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A simplified technique of esophageal self-expandable
metallic stent placement without fluoroscopic and
endoscopic guidance for treating esophageal carcinoma
ABSTRACT
Background/Aims: Self-expandable metallic stent (SEMS) placement with fluoroscopic guidance is a commonly used technique to
relieve obstruction in patients with esophageal carcinoma. However, it has disadvantages such as radiation exposure. SEMS placement
with endoscopic guidance also has the disadvantages of causing discomfort to patients as the endoscope and SEMS assembly are
simultaneously used and it needs two experts for the procedure to be performed. To overcome these disadvantages, a simplified tech-
nique for SEMS placement was developed that does not require fluoroscopic or endoscopic guidance. Our objective was to compare the
efficacy and safety of this simplified technique with the conventional SEMS placement method.
Materials and Methods: This is a retrospective study including patients with esophageal carcinoma who underwent SEMS placement
for the palliation of dysphagia.
Results: Sixty-two patients were placed on stents for the palliation for esophageal carcinoma, with 46 patients in the conventional
technique group (group A) and 16 in the simplified technique group (group B). The duration of the procedure was considerably lesser in
group B than in group A (2 min 53 s vs. 15 min 4 s, p=0.001). The technical success rate achieved in groups A and B were 97.82% and
100%, respectively. SEMS placement required two experts in the conventional technique whereas the simplified technique required only
one expert.
Conclusion: The advantages of the simplified technique are as follows: technical ease, cost-effectiveness, no exposure to radiation,
requirement of minimal manpower, and less time-consuming; these advantages make it the technique day-care procedure.
Keywords: Self-expandable metallic stent, esophageal carcinoma, fluoroscopy, dysphagia, simplified technique
INTRODUCTION
Esophageal cancer is the eighth most common cancer
among all cancers worldwide, with a substantially increas-
ing prevalence. More than 50% of patients present with
either locally advanced disease or metastasis at the time
of diagnosis (1). Self-expandable metallic stent (SEMS)
placement is imperative in the amelioration of dysphagia,
thereby enhancing the quality of life of patients (1). Fur-
thermore, the use of SEMSs is explicitly associated with
relatively lower morbidity and mortality rates than the use
of plastic stents (2).
Earlier studies had evinced that SEMS placement is per-
formed under fluoroscopic or endoscopic guidance. How-
ever, the limited accessibility to fluoroscopy and the haz-
ard of radiation exposure are established as the two main
pitfalls pertaining to fluoroscopic guidance (3). Although
endoscopic guidance during SEMS placement is an effort
to overcome these limitations, it had a constraint of af-
fecting patient compliance during the procedure, thereby
demanding the use of a nasogastroscope or an ultra-thin
scope (4). The other disadvantage is that it requires two
experts to perform the procedure. The first expert is
needed to place the SEMS, and the second expert per-
forms endoscopy and assists the first expert to place the
stent under endoscopic guidance. Therefore, we devel-
oped a simplified technique of SEMS placement without
fluoroscopic guidance and with limited endoscopic guid-
ance i.e., endoscopy was used only to assess the extent
of the carcinoma of esophagus and not during the stent
82
Cite this article as: Kini R, Ramanathan S, Thangavel P, Karunakaran P, Mohamed KS, Ananthavadivelu M. A simplified technique of
esophageal self-expandable metallic stent placement without fluoroscopic and endoscopic guidance for treating esophageal
carcinoma. Turk J Gastroenterol 2018; 29: 82-8.
GASTROINTESTINAL ENDOSCOPY
Address for Correspondence: Ratnakar Kini E-mail: gastrokini@gmail.com
Received: February 22, 2017 Accepted: September 11, 2017
© Copyright 2018 by The Turkish Society of Gastroenterology • Available online at www.turkjgastroenterol.org
DOI: 10.5152/tjg.2018.17112
ORIGINAL ARTICLE
ORCID IDs of the authors: R.K.0000-0002-0421-5960; S.R. 0000-0002-6292-7341; P.T. 0000-0003-3562-0130; P.K. 0000-0002-7711-
9478; K.M. 0000-0001-9732-3612; M.A. 0000-0002-1499-8911
Ratnakar Kini , Sabarinathan Ramanathan , Pugazhendhi Thangavel , Premkumar Karunakaran , Kani Shaik Mohamed ,
Murali Ananthavadivelu
Department of Medical Gastroenterology, Madras Medical College and Rajiv Gandhi Government General Hospital, Tamil Nadu, India
deployment. In this study, we compared the safety and
efficacy of the simplified technique of esophageal SEMS
placement (without fluoroscopic guidance) with that of
the conventional method (with fluoroscopic guidance) in
patients with advanced esophageal carcinoma.
MATERIALS AND METHODS
This retrospective study was conducted with prior in-
stitutional ethics committee approval. The endoscopy
registry and inpatient case records of patients who were
diagnosed of advanced esophageal carcinoma and who
underwent SEMS placement between January 2012 and
September 2016 were analyzed. Telephone calls were
made to collect data whenever necessary. During this
study period, all patients in who underwent SEMS place-
ment were divided into two groups on depending on
whether fluoroscopic guidance was performed. Patients
who were aged over 18 years and with histopathological-
ly proven carcinoma of the esophagus not amenable to
curative treatment were included. Patients with tumors
located 2-3 cm close to the cricopharyngeus muscle
and who required the placement of more than one stent
or telescopic SEMS were excluded. Pre-procedural in-
formed consent was obtained from the patients.
Data pertaining to the early and late complications of
stent placement were obtained from the case records.
Complications were defined as early and late based on
those occurring before SEMS placement and 7 days after
SEMS placement (5).
Dysphagia scoring was done before and after the proce-
dure:
Grade 0: no dysphagia, able to tolerate normal food
Grade 1: able to swallow most foods
Grade 2: able to swallow a soft diet
Grade 3: able to swallow liquid only
Grade 4: unable to swallow saliva
Technical success was defined as the ability to accurately
place and expand the stent at the desired level in the first
attempt.
Technique
Conventional technique (with fluoroscopic guidance)-
group A
Under conscious sedation with intravenous midazolam
and fentanyl, esophagogastroduodenoscopy (EGD) was
performed to compute the proximal and distal extents of
the lesion. Whenever dilatation was needed, a guide wire
(0.035 inch with a soft tip) was placed across carcinoma
of esophagus and it was dilated with serial Savary-Gilliard
bougies. The proximal and distal extents of the tumor
were marked under fluoroscopic guidance either by an
external radiopaque marker or by the submucosal injec-
tion of a contrast material serving as an internal marker.
The guide wire was lodged in the antrum of the stomach,
further after withdrawal of the endoscope the SEMS as-
sembly would be threaded over the guide wire. The SEMS
was placed by the distal release technique. During and
after placement, the proper positioning of the SEMS was
firmly established fluoroscopically and the expansion of
the SEMS was endoscopically confirmed on the next day
of the procedure.
Simplified technique (without fluoroscopic or
endoscopic guidance)-group B
With conscious sedation, EGD was performed to deter-
mine the anatomical level of the esophagogastric junc-
tion and proximal and distal extents of the lesion as
well as to locate the cricopharynx. The proximal extent
of the carcinoma of esopghagus (Figure 1) was noted
83
Turk J Gastroenterol 2018; 29: 82-8	 Kini et al. A simplified technique of esophageal self-expandable
metallic stent placement
Figure 1. Endoscopic view of the upper level of carcinoma of esopha-
gus [In this case, it was noted at 24 cm (X)]
in centimeters from the incisor teeth (X). The proximal
end of the stent was planned to be placed at least 2 cm
above this level (X-2). Factor (X-2) is to account for the
expanded portion of the SEMS. This level (X-2) was not-
ed over the graduation visualized in the inner sheath of
the stent assembly seen through the transparent outer
sheath (Figure 2). The stent assembly was then threaded
over the guide wire till the (X-2) mark on the stent as-
sembly reached the incisor teeth (Figure 3). At this point,
the marking on the stent assembly (X-2) at the incisor
teeth was the same as the distance at which the proxi-
mal extent of the stent was planned to be placed. After
confirming this, stent placement was slowly performing
using the distal release technique (Figure 4). Post-pro-
cedure endoscopy was performed to affirm the position
of the proximal end of SEMS (Figure 5a,b). After SEMS
placement, the patients were placed in the semi recum-
bent position and kept nil orally and the infusion of clear
oral fluids was started 6 h later. The following day, a soft
semi-solid diet was initiated according to the tolerance
of the patient.
Statistical analysis
Statistical analysis was performed using (IBM Inc.; SPSS
Statistics for Windows, Version 24.0. Armonk, NY, ABD)
The independent samples t-test and paired t-test were
used to compare patients between the two groups and
within the groups, respectively. The Mann-Whitney U
test was performed for quantitative variables. p<0.05 was
considered as the level of significance.
84
Kini et al. A simplified technique of esophageal self-expandable	 Turk J Gastroenterol 2018; 29: 82-8
metallic stent placement
Figure 4. The 22-cm mark on the stent assembly was kept at the
incisor teeth. Stent placement was done slowly using the distal
release technique
Figure 2. The level of 22 cm (X-2) noted on the stent assembly indi-
cated by a red arrow
Figure 3. The stent assembly threaded over the guide wire till the 22-
cm mark on the stent assembly reaches the incisor teeth (red arrow)
RESULTS
A total of 62 patients were placed on stents for the palli-
ation for esophageal carcinoma, with 46 patients in group
A and 16 in group B. The demographic findings and char-
acteristics of the patients are shown in Table 1. The mean
age of the patients was 57.7±12.5 y. There was no statisti-
cally significant difference in the age of the patients in the
two groups (p=0.535). Of the 62 patients included in the
study, 46 were male and 16 were female. In groups A and
B, the most common site of the tumor was mid-esopha-
gus, as observed in about 65.22% and 68.75% of the pa-
tients, respectively. The existence of tracheoesophageal
fistula was observed in about 16 patients. The extent of
the lesion was about 8.4±2.8 cm and 7.5±2.1 cm in groups
A and B, respectively, and was almost homogenous in both
the groups (p=0.274). Considering the type of carcinoma,
squamous cell carcinoma was the most common histo-
pathological type observed in both study groups. Dyspha-
gia was evaluated before and after the procedure with the
dysphagia score. The dysphagia score was not significantly
different between the groups (Table 2). There was a statis-
tically significant difference within the groups (p= 0.001 in
both groups) before and after SEMS placement, suggest-
ing a greater degree of improvement in dysphagia in both
groups. The mean duration of the procedure was 15 min
4 s in group A and 2 min 53 s in group B; this difference
85
Turk J Gastroenterol 2018; 29: 82-8	 Kini et al. A simplified technique of esophageal self-expandable
metallic stent placement
		 With 	 Without
		 fluoroscopic	 fluoroscopic
		 guidance 	 guidance
Variable	 (n=46)	 (n=16)	p
Age (years)	 58.8±11.7	 56.6±13.3	 0.535
Sex, n (%)
	 Male	 33 (71.74%)	 13 (81.25%)	 0.458
	 Female	 13 (28.26%)	 3 (18.75%)	
Tumor site, n (%)
	 Upper esophagus	 7 (15.22%)	 3 (18.75%)	 0.743
	 Mid-esophagus	 30 (65.22%)	 11 (68.75%)	 0.799
	 Lower esophagus 	 9 (19.56%)	 2 (12.5%)	 0.527
Tracheoesophageal 	 13 (28.26%)	 3 (18.75%)	 0.458
fistula, n (%)	
Lesion extent (cm)	 8.4±2.8	 7.5±2.1	 0.274
Type of carcinoma, n (%)
	 Squamous cell carcinoma	41 (89.13%)	 14 (87.5%)	 0.860
	 Adenocarcinoma	 4 (8.7%)	 2 (12.5%)	 0.660
	 Undifferentiated	 1 (2.17%)	 0 (0%)	 0.555
Table 1. Demographic characteristics and features of the
patients
Figure 5. a, b. (a) Endoscopic appearance of the esophageal SEMS
after placement (b) The proximal end of the SEMS at 22 cm of the
esophagus from the incisors as confirmed by the marking on the
endoscope (yellow arrow)
a
b
was statistically significant (p=0.001), suggesting the su-
periority of the simplified technique over the conventional
technique. The technical success rate achieved in groups
A and B were 97.82% and 100%, respectively. The con-
ventional technique needed two experts for SEMS place-
ment, whereas the simplified technique needed only one
expert. With regard to immediate complications, 26.08%
and 6.25% of the patients in groups A and B, respectively,
underwent SEMS repositioning due to distal migration. In
group A, two patients developed aspiration and one patient
underwent stent removal due to lodging of the SEMS in
the cricopharynx during repositioning. Both complications
were not seen in group B. Other immediate complications
such as perforation, delivery system entrapment, and pro-
cedure-related mortality were not present in both groups.
Early complications (≤7 days) and late complications (>7
days) observed in the study groups were similar, with no
statistically significant difference between them (Table 3).
The patients were followed up at the end of one week and
every month thereafter. Four patients in group A and one
patient in group B were lost to follow-up.
DISCUSSION
Esophageal SEMS placement is extremely efficacious in
the palliation of dysphagia due to carcinoma of esopha-
gus (6). SEMS placement has advantages of being tech-
nically compliant and brings about the immediate relief
of symptoms, resulting in it becoming the treatment of
choice in patients with unresectable esophageal carcino-
ma,, including those complicated by fistulas (7). SEMS is
slightly better than rigid plastic stents in the palliation of
dysphagia (8), thereby significantly improving the quality
of life of patients (9,10).
SEMS placement with fluoroscopic guidance has the dis-
advantage of the non-feasibility of using the fluoroscop-
ic system in hospitals with limited settings in developing
countries (11, 12). Occasionally, it also causes problems
such as the migration of an external marker on move-
ment, dissolution of the contrast agent used as an inter-
nal marker, and more importantly, hazardous radiation
exposure. To overcome these issues, another technique
is sought that necessitates the use of endoscopy alone
for SEMS placement and its safety and efficacy is com-
parable to fluoroscopic guidance (2,13-20). There are few
studies stating that the individual use of endoscopy is not
feasible in patients with upper esophageal carcinoma and
those with tight strictures. It also inconveniences patients
due to insertion of an endoscope and the stent assembly,
thereby requiring the use of ultra-thin or slim endoscopy
(3,12). Considering this, we developed a simplified tech-
nique that could be safely performed in settings where
		 With 	 Without
		 fluoroscopic	 fluoroscopic
		 guidance 	 guidance
Variable	 (n=46)	 (n=16)	p
Dysphagia score
	Before	 2.8±0.58	 3±0.63	 0.453
	After	 0.39±0.57	 0.43±0.62	 0.798
Mean procedure duration 	 15 min 4s	 2 min 53sec	 0.001
Technical success rate	 97.82%	 100%	 0.555
No. of experts (main+	 1+1	 1+0
assistant) involved		
Table 2. Outcomes and results
		 With 	 Without
		 fluoroscopic	fluoroscopic
		 guidance 	 guidance
Variable	 (n=46)	 (n=16)	p
Immediate complications
SEMS repositioning	
	 Stent removal	 12 (26.08%)	 0 (0%)	 0 (0%)
	 Perforation	 1 (2.17%)	 1 (6.25%)	 0 (0%)
	 Aspiration	 0 (0%)	 0 (0%)	 0.096
	 Delivery system entrapment	 2 (4.35%)	 0 (0%)	 0.555
	 Procedure-related mortality 	 0 (0%)	 0 (0%)	 0.400
Early complications (≤7 days)
	 Chest pain	 14 (30.43%)	 4 (25%)	 0.682
	 Nausea and vomiting	 9 (19.56%)	 3 (18.75%)	 0.944
	 Upper gastrointestinal	 1 (2.17%)	 0 (0%)	 0.555
	bleeding	
Late complications (>7 days)
	 Gastroesophageal reflux	 6 (14.28%)	 3 (20%)	 0.606
	 Tumor outgrowth	 10 (23.80%)	 4 (26.67 %)	 0.827
	 Migration	 2 (4.76%)	 0 (0%)	 0.394
	 Bleeding 	 0 (0 %)	 0 (0%)
Food impaction	 4 (9.52%)	 1(6.67%)	 0.739
Lost to follow-up	 4	 1	
Table 3. Post-procedure complications
86
Kini et al. A simplified technique of esophageal self-expandable	 Turk J Gastroenterol 2018; 29: 82-8
metallic stent placement
fluoroscopic guidance and ultra-thin endoscopy are lack-
ing. This technique is applicable only for stents that have
external ruler markings used for measuring and judging
stent placement.
In our simplified technique group, fully covered Niti-STM
Esophageal stent(outer diameter, 18 mm and length, 15
cm;Taewoong Medical Co.) was placed in 15 patients, and
a fully covered OttomedTM
Bravo esophageal stent (outer
diameter, 18 mm and length, 14 cm; Mitra Medical Ser-
vices) was placed in 1 patient. Stents with outer diam-
eters of 18 and 22 mm and lengths of 10 to 16 cm that
were either partially or fully covered such as NITI-S, Ultra-
flex, or Endotechnik, based on the availability, were used
in the conventional group in our study.
This study compared stent placement with or without
fluoroscopic guidance in a single institution and used pa-
tients of similar demographics and characteristics. Both
groups exhibited a comparable statistical significant im-
provement in dysphagia. Immediate, early, and late com-
plications were homogenous between the groups, reveal-
ing that both techniques are equally safe.
The main advantage of the simplified technique is the
reduction in procedure duration compared with that in
the conventional method (2 min 53 s vs. 15 min 4 s).
This study also shows that the simplified technique is
highly efficacious in terms of its technical success rate
(100%). The other advantages that increase the value of
the simplified technique are as follows: technical ease,
cost-effectiveness, and no hazardous radiation expo-
sure; therefore, this technique can be used as a day-care
procedure.
The additional advantage is that it requires only one expert
to advance the stent assembly, thereby minimizing man-
power; the conventional technique requires two experts:
one for fixing the markers and operating the fluoroscope
and the other for advancing the stent assembly. In the
method used for stent placement under only endoscopic
guidance, two experts are needed: one to handle the en-
doscope and the other to place the stent. Through-the-
scope stents are also available (Tae Woong Medical); they
serve the purpose of no radiation use and single operator
delivery. Table 4 shows a comparison between various
techniques of esophageal SEMS placement.
Some limitations of this study are as follows: retrospec-
tive nature of the study and smaller sample size in the
simplified technique group. Further prospective studies
in a larger population would add value in terms of the
safety and efficacy of the simplified technique of SEMS
placement. Stents in the simplified technique are all
fully covered, whereas those in the conventional tech-
nique have various stent diameters and lengths and
are also covered and uncovered; thus, a head-to-head
comparison and outcomes measures cannot be made
with surety.
After reviewing the literature, we found that there were
no data available till date regarding SEMS placement us-
ing the simplified technique. We invented this new meth-
od of SEMS placement, which is simple, safe, effective,
precise, requires minimal manpower, is less time-con-
suming, and without radiation exposure. Hence, we pro-
pose that this simplified method would have a promising
role in SEMS placement in the future after more compre-
hensive evaluations in a larger series.
87
Turk J Gastroenterol 2018; 29: 82-8	 Kini et al. A simplified technique of esophageal self-expandable
metallic stent placement
		 Under fluoroscopic 	 Under endoscopic	 Simplified
S.No.		 guidance	 guidance	 technique
1.	 Fluoroscopy 	 Needed 	 Not needed 	 Not needed
2.	 Exposure to radiation	 Present 	 Absent 	 Absent
3.	 Placement of external/internal marker	 Required 	 Not required	 Not required
4.	 Number of experts needed	 Two 	 Two 	 One
5.	 Simultaneous use of stent assembly and endoscopy	 No 	 Yes 	 No
6.	 Duration of the procedure	 Long 	 Short 	 Very short
7.	 Patient comfort	 Good 	 Not good	 Good
Table 4. Comparison between various methods of esophageal SEMS placement
Ethics Committee Approval: Ethics committee approval was
received for this study from institutional ethics committee of
Madras Medical College (Decision Date: 02.08.2016/Decision
No: 05082016)
Informed Consent: Written informed consent was obtained
from patients who participated in this study.
Peer-review: Externally peer-reviewed.
Author contributions: Concept - R.K.; Design - R.K., S.R., P.T.;
Supervision - R.K., P.T., M.A.; Resource - R.K., P.K., K.M.; Materi-
als - R.K., P.K., K.M.; Data Collection and/or Processing - R.K., S.R.;
Analysis and/or Interpretation - R.K., S.R., P.K.; Literature Search -
R.K., R.S., K.M.; Writing - R.K., R.S.; Critical Reviews - P.T., M.A., P.K.
Acknowledgements: The authors sincerely thank all patients for
their participation in this study, the nursing staff of Institute of
Medical Gastroenterology of Madras Medical College and Rajiv
Gandhi Government General Hospital for their support and Dr.
Breetha Sabarinathan and Dr. Amudhan Aravind towards pre-
paring this manuscript.
Conflict of Interest: No conflict of interest was declared by the
authors.
Financial Disclosure: The authors declared that this study has
received no financial support.
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metallic stent placement

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A simplified technique of esophageal self-expandable metallic stent placement without fluoroscopic and endoscopic guidance for treating esophageal carcinoma

  • 1. A simplified technique of esophageal self-expandable metallic stent placement without fluoroscopic and endoscopic guidance for treating esophageal carcinoma ABSTRACT Background/Aims: Self-expandable metallic stent (SEMS) placement with fluoroscopic guidance is a commonly used technique to relieve obstruction in patients with esophageal carcinoma. However, it has disadvantages such as radiation exposure. SEMS placement with endoscopic guidance also has the disadvantages of causing discomfort to patients as the endoscope and SEMS assembly are simultaneously used and it needs two experts for the procedure to be performed. To overcome these disadvantages, a simplified tech- nique for SEMS placement was developed that does not require fluoroscopic or endoscopic guidance. Our objective was to compare the efficacy and safety of this simplified technique with the conventional SEMS placement method. Materials and Methods: This is a retrospective study including patients with esophageal carcinoma who underwent SEMS placement for the palliation of dysphagia. Results: Sixty-two patients were placed on stents for the palliation for esophageal carcinoma, with 46 patients in the conventional technique group (group A) and 16 in the simplified technique group (group B). The duration of the procedure was considerably lesser in group B than in group A (2 min 53 s vs. 15 min 4 s, p=0.001). The technical success rate achieved in groups A and B were 97.82% and 100%, respectively. SEMS placement required two experts in the conventional technique whereas the simplified technique required only one expert. Conclusion: The advantages of the simplified technique are as follows: technical ease, cost-effectiveness, no exposure to radiation, requirement of minimal manpower, and less time-consuming; these advantages make it the technique day-care procedure. Keywords: Self-expandable metallic stent, esophageal carcinoma, fluoroscopy, dysphagia, simplified technique INTRODUCTION Esophageal cancer is the eighth most common cancer among all cancers worldwide, with a substantially increas- ing prevalence. More than 50% of patients present with either locally advanced disease or metastasis at the time of diagnosis (1). Self-expandable metallic stent (SEMS) placement is imperative in the amelioration of dysphagia, thereby enhancing the quality of life of patients (1). Fur- thermore, the use of SEMSs is explicitly associated with relatively lower morbidity and mortality rates than the use of plastic stents (2). Earlier studies had evinced that SEMS placement is per- formed under fluoroscopic or endoscopic guidance. How- ever, the limited accessibility to fluoroscopy and the haz- ard of radiation exposure are established as the two main pitfalls pertaining to fluoroscopic guidance (3). Although endoscopic guidance during SEMS placement is an effort to overcome these limitations, it had a constraint of af- fecting patient compliance during the procedure, thereby demanding the use of a nasogastroscope or an ultra-thin scope (4). The other disadvantage is that it requires two experts to perform the procedure. The first expert is needed to place the SEMS, and the second expert per- forms endoscopy and assists the first expert to place the stent under endoscopic guidance. Therefore, we devel- oped a simplified technique of SEMS placement without fluoroscopic guidance and with limited endoscopic guid- ance i.e., endoscopy was used only to assess the extent of the carcinoma of esophagus and not during the stent 82 Cite this article as: Kini R, Ramanathan S, Thangavel P, Karunakaran P, Mohamed KS, Ananthavadivelu M. A simplified technique of esophageal self-expandable metallic stent placement without fluoroscopic and endoscopic guidance for treating esophageal carcinoma. Turk J Gastroenterol 2018; 29: 82-8. GASTROINTESTINAL ENDOSCOPY Address for Correspondence: Ratnakar Kini E-mail: gastrokini@gmail.com Received: February 22, 2017 Accepted: September 11, 2017 © Copyright 2018 by The Turkish Society of Gastroenterology • Available online at www.turkjgastroenterol.org DOI: 10.5152/tjg.2018.17112 ORIGINAL ARTICLE ORCID IDs of the authors: R.K.0000-0002-0421-5960; S.R. 0000-0002-6292-7341; P.T. 0000-0003-3562-0130; P.K. 0000-0002-7711- 9478; K.M. 0000-0001-9732-3612; M.A. 0000-0002-1499-8911 Ratnakar Kini , Sabarinathan Ramanathan , Pugazhendhi Thangavel , Premkumar Karunakaran , Kani Shaik Mohamed , Murali Ananthavadivelu Department of Medical Gastroenterology, Madras Medical College and Rajiv Gandhi Government General Hospital, Tamil Nadu, India
  • 2. deployment. In this study, we compared the safety and efficacy of the simplified technique of esophageal SEMS placement (without fluoroscopic guidance) with that of the conventional method (with fluoroscopic guidance) in patients with advanced esophageal carcinoma. MATERIALS AND METHODS This retrospective study was conducted with prior in- stitutional ethics committee approval. The endoscopy registry and inpatient case records of patients who were diagnosed of advanced esophageal carcinoma and who underwent SEMS placement between January 2012 and September 2016 were analyzed. Telephone calls were made to collect data whenever necessary. During this study period, all patients in who underwent SEMS place- ment were divided into two groups on depending on whether fluoroscopic guidance was performed. Patients who were aged over 18 years and with histopathological- ly proven carcinoma of the esophagus not amenable to curative treatment were included. Patients with tumors located 2-3 cm close to the cricopharyngeus muscle and who required the placement of more than one stent or telescopic SEMS were excluded. Pre-procedural in- formed consent was obtained from the patients. Data pertaining to the early and late complications of stent placement were obtained from the case records. Complications were defined as early and late based on those occurring before SEMS placement and 7 days after SEMS placement (5). Dysphagia scoring was done before and after the proce- dure: Grade 0: no dysphagia, able to tolerate normal food Grade 1: able to swallow most foods Grade 2: able to swallow a soft diet Grade 3: able to swallow liquid only Grade 4: unable to swallow saliva Technical success was defined as the ability to accurately place and expand the stent at the desired level in the first attempt. Technique Conventional technique (with fluoroscopic guidance)- group A Under conscious sedation with intravenous midazolam and fentanyl, esophagogastroduodenoscopy (EGD) was performed to compute the proximal and distal extents of the lesion. Whenever dilatation was needed, a guide wire (0.035 inch with a soft tip) was placed across carcinoma of esophagus and it was dilated with serial Savary-Gilliard bougies. The proximal and distal extents of the tumor were marked under fluoroscopic guidance either by an external radiopaque marker or by the submucosal injec- tion of a contrast material serving as an internal marker. The guide wire was lodged in the antrum of the stomach, further after withdrawal of the endoscope the SEMS as- sembly would be threaded over the guide wire. The SEMS was placed by the distal release technique. During and after placement, the proper positioning of the SEMS was firmly established fluoroscopically and the expansion of the SEMS was endoscopically confirmed on the next day of the procedure. Simplified technique (without fluoroscopic or endoscopic guidance)-group B With conscious sedation, EGD was performed to deter- mine the anatomical level of the esophagogastric junc- tion and proximal and distal extents of the lesion as well as to locate the cricopharynx. The proximal extent of the carcinoma of esopghagus (Figure 1) was noted 83 Turk J Gastroenterol 2018; 29: 82-8 Kini et al. A simplified technique of esophageal self-expandable metallic stent placement Figure 1. Endoscopic view of the upper level of carcinoma of esopha- gus [In this case, it was noted at 24 cm (X)]
  • 3. in centimeters from the incisor teeth (X). The proximal end of the stent was planned to be placed at least 2 cm above this level (X-2). Factor (X-2) is to account for the expanded portion of the SEMS. This level (X-2) was not- ed over the graduation visualized in the inner sheath of the stent assembly seen through the transparent outer sheath (Figure 2). The stent assembly was then threaded over the guide wire till the (X-2) mark on the stent as- sembly reached the incisor teeth (Figure 3). At this point, the marking on the stent assembly (X-2) at the incisor teeth was the same as the distance at which the proxi- mal extent of the stent was planned to be placed. After confirming this, stent placement was slowly performing using the distal release technique (Figure 4). Post-pro- cedure endoscopy was performed to affirm the position of the proximal end of SEMS (Figure 5a,b). After SEMS placement, the patients were placed in the semi recum- bent position and kept nil orally and the infusion of clear oral fluids was started 6 h later. The following day, a soft semi-solid diet was initiated according to the tolerance of the patient. Statistical analysis Statistical analysis was performed using (IBM Inc.; SPSS Statistics for Windows, Version 24.0. Armonk, NY, ABD) The independent samples t-test and paired t-test were used to compare patients between the two groups and within the groups, respectively. The Mann-Whitney U test was performed for quantitative variables. p<0.05 was considered as the level of significance. 84 Kini et al. A simplified technique of esophageal self-expandable Turk J Gastroenterol 2018; 29: 82-8 metallic stent placement Figure 4. The 22-cm mark on the stent assembly was kept at the incisor teeth. Stent placement was done slowly using the distal release technique Figure 2. The level of 22 cm (X-2) noted on the stent assembly indi- cated by a red arrow Figure 3. The stent assembly threaded over the guide wire till the 22- cm mark on the stent assembly reaches the incisor teeth (red arrow)
  • 4. RESULTS A total of 62 patients were placed on stents for the palli- ation for esophageal carcinoma, with 46 patients in group A and 16 in group B. The demographic findings and char- acteristics of the patients are shown in Table 1. The mean age of the patients was 57.7±12.5 y. There was no statisti- cally significant difference in the age of the patients in the two groups (p=0.535). Of the 62 patients included in the study, 46 were male and 16 were female. In groups A and B, the most common site of the tumor was mid-esopha- gus, as observed in about 65.22% and 68.75% of the pa- tients, respectively. The existence of tracheoesophageal fistula was observed in about 16 patients. The extent of the lesion was about 8.4±2.8 cm and 7.5±2.1 cm in groups A and B, respectively, and was almost homogenous in both the groups (p=0.274). Considering the type of carcinoma, squamous cell carcinoma was the most common histo- pathological type observed in both study groups. Dyspha- gia was evaluated before and after the procedure with the dysphagia score. The dysphagia score was not significantly different between the groups (Table 2). There was a statis- tically significant difference within the groups (p= 0.001 in both groups) before and after SEMS placement, suggest- ing a greater degree of improvement in dysphagia in both groups. The mean duration of the procedure was 15 min 4 s in group A and 2 min 53 s in group B; this difference 85 Turk J Gastroenterol 2018; 29: 82-8 Kini et al. A simplified technique of esophageal self-expandable metallic stent placement With Without fluoroscopic fluoroscopic guidance guidance Variable (n=46) (n=16) p Age (years) 58.8±11.7 56.6±13.3 0.535 Sex, n (%) Male 33 (71.74%) 13 (81.25%) 0.458 Female 13 (28.26%) 3 (18.75%) Tumor site, n (%) Upper esophagus 7 (15.22%) 3 (18.75%) 0.743 Mid-esophagus 30 (65.22%) 11 (68.75%) 0.799 Lower esophagus 9 (19.56%) 2 (12.5%) 0.527 Tracheoesophageal 13 (28.26%) 3 (18.75%) 0.458 fistula, n (%) Lesion extent (cm) 8.4±2.8 7.5±2.1 0.274 Type of carcinoma, n (%) Squamous cell carcinoma 41 (89.13%) 14 (87.5%) 0.860 Adenocarcinoma 4 (8.7%) 2 (12.5%) 0.660 Undifferentiated 1 (2.17%) 0 (0%) 0.555 Table 1. Demographic characteristics and features of the patients Figure 5. a, b. (a) Endoscopic appearance of the esophageal SEMS after placement (b) The proximal end of the SEMS at 22 cm of the esophagus from the incisors as confirmed by the marking on the endoscope (yellow arrow) a b
  • 5. was statistically significant (p=0.001), suggesting the su- periority of the simplified technique over the conventional technique. The technical success rate achieved in groups A and B were 97.82% and 100%, respectively. The con- ventional technique needed two experts for SEMS place- ment, whereas the simplified technique needed only one expert. With regard to immediate complications, 26.08% and 6.25% of the patients in groups A and B, respectively, underwent SEMS repositioning due to distal migration. In group A, two patients developed aspiration and one patient underwent stent removal due to lodging of the SEMS in the cricopharynx during repositioning. Both complications were not seen in group B. Other immediate complications such as perforation, delivery system entrapment, and pro- cedure-related mortality were not present in both groups. Early complications (≤7 days) and late complications (>7 days) observed in the study groups were similar, with no statistically significant difference between them (Table 3). The patients were followed up at the end of one week and every month thereafter. Four patients in group A and one patient in group B were lost to follow-up. DISCUSSION Esophageal SEMS placement is extremely efficacious in the palliation of dysphagia due to carcinoma of esopha- gus (6). SEMS placement has advantages of being tech- nically compliant and brings about the immediate relief of symptoms, resulting in it becoming the treatment of choice in patients with unresectable esophageal carcino- ma,, including those complicated by fistulas (7). SEMS is slightly better than rigid plastic stents in the palliation of dysphagia (8), thereby significantly improving the quality of life of patients (9,10). SEMS placement with fluoroscopic guidance has the dis- advantage of the non-feasibility of using the fluoroscop- ic system in hospitals with limited settings in developing countries (11, 12). Occasionally, it also causes problems such as the migration of an external marker on move- ment, dissolution of the contrast agent used as an inter- nal marker, and more importantly, hazardous radiation exposure. To overcome these issues, another technique is sought that necessitates the use of endoscopy alone for SEMS placement and its safety and efficacy is com- parable to fluoroscopic guidance (2,13-20). There are few studies stating that the individual use of endoscopy is not feasible in patients with upper esophageal carcinoma and those with tight strictures. It also inconveniences patients due to insertion of an endoscope and the stent assembly, thereby requiring the use of ultra-thin or slim endoscopy (3,12). Considering this, we developed a simplified tech- nique that could be safely performed in settings where With Without fluoroscopic fluoroscopic guidance guidance Variable (n=46) (n=16) p Dysphagia score Before 2.8±0.58 3±0.63 0.453 After 0.39±0.57 0.43±0.62 0.798 Mean procedure duration 15 min 4s 2 min 53sec 0.001 Technical success rate 97.82% 100% 0.555 No. of experts (main+ 1+1 1+0 assistant) involved Table 2. Outcomes and results With Without fluoroscopic fluoroscopic guidance guidance Variable (n=46) (n=16) p Immediate complications SEMS repositioning Stent removal 12 (26.08%) 0 (0%) 0 (0%) Perforation 1 (2.17%) 1 (6.25%) 0 (0%) Aspiration 0 (0%) 0 (0%) 0.096 Delivery system entrapment 2 (4.35%) 0 (0%) 0.555 Procedure-related mortality 0 (0%) 0 (0%) 0.400 Early complications (≤7 days) Chest pain 14 (30.43%) 4 (25%) 0.682 Nausea and vomiting 9 (19.56%) 3 (18.75%) 0.944 Upper gastrointestinal 1 (2.17%) 0 (0%) 0.555 bleeding Late complications (>7 days) Gastroesophageal reflux 6 (14.28%) 3 (20%) 0.606 Tumor outgrowth 10 (23.80%) 4 (26.67 %) 0.827 Migration 2 (4.76%) 0 (0%) 0.394 Bleeding 0 (0 %) 0 (0%) Food impaction 4 (9.52%) 1(6.67%) 0.739 Lost to follow-up 4 1 Table 3. Post-procedure complications 86 Kini et al. A simplified technique of esophageal self-expandable Turk J Gastroenterol 2018; 29: 82-8 metallic stent placement
  • 6. fluoroscopic guidance and ultra-thin endoscopy are lack- ing. This technique is applicable only for stents that have external ruler markings used for measuring and judging stent placement. In our simplified technique group, fully covered Niti-STM Esophageal stent(outer diameter, 18 mm and length, 15 cm;Taewoong Medical Co.) was placed in 15 patients, and a fully covered OttomedTM Bravo esophageal stent (outer diameter, 18 mm and length, 14 cm; Mitra Medical Ser- vices) was placed in 1 patient. Stents with outer diam- eters of 18 and 22 mm and lengths of 10 to 16 cm that were either partially or fully covered such as NITI-S, Ultra- flex, or Endotechnik, based on the availability, were used in the conventional group in our study. This study compared stent placement with or without fluoroscopic guidance in a single institution and used pa- tients of similar demographics and characteristics. Both groups exhibited a comparable statistical significant im- provement in dysphagia. Immediate, early, and late com- plications were homogenous between the groups, reveal- ing that both techniques are equally safe. The main advantage of the simplified technique is the reduction in procedure duration compared with that in the conventional method (2 min 53 s vs. 15 min 4 s). This study also shows that the simplified technique is highly efficacious in terms of its technical success rate (100%). The other advantages that increase the value of the simplified technique are as follows: technical ease, cost-effectiveness, and no hazardous radiation expo- sure; therefore, this technique can be used as a day-care procedure. The additional advantage is that it requires only one expert to advance the stent assembly, thereby minimizing man- power; the conventional technique requires two experts: one for fixing the markers and operating the fluoroscope and the other for advancing the stent assembly. In the method used for stent placement under only endoscopic guidance, two experts are needed: one to handle the en- doscope and the other to place the stent. Through-the- scope stents are also available (Tae Woong Medical); they serve the purpose of no radiation use and single operator delivery. Table 4 shows a comparison between various techniques of esophageal SEMS placement. Some limitations of this study are as follows: retrospec- tive nature of the study and smaller sample size in the simplified technique group. Further prospective studies in a larger population would add value in terms of the safety and efficacy of the simplified technique of SEMS placement. Stents in the simplified technique are all fully covered, whereas those in the conventional tech- nique have various stent diameters and lengths and are also covered and uncovered; thus, a head-to-head comparison and outcomes measures cannot be made with surety. After reviewing the literature, we found that there were no data available till date regarding SEMS placement us- ing the simplified technique. We invented this new meth- od of SEMS placement, which is simple, safe, effective, precise, requires minimal manpower, is less time-con- suming, and without radiation exposure. Hence, we pro- pose that this simplified method would have a promising role in SEMS placement in the future after more compre- hensive evaluations in a larger series. 87 Turk J Gastroenterol 2018; 29: 82-8 Kini et al. A simplified technique of esophageal self-expandable metallic stent placement Under fluoroscopic Under endoscopic Simplified S.No. guidance guidance technique 1. Fluoroscopy Needed Not needed Not needed 2. Exposure to radiation Present Absent Absent 3. Placement of external/internal marker Required Not required Not required 4. Number of experts needed Two Two One 5. Simultaneous use of stent assembly and endoscopy No Yes No 6. Duration of the procedure Long Short Very short 7. Patient comfort Good Not good Good Table 4. Comparison between various methods of esophageal SEMS placement
  • 7. Ethics Committee Approval: Ethics committee approval was received for this study from institutional ethics committee of Madras Medical College (Decision Date: 02.08.2016/Decision No: 05082016) Informed Consent: Written informed consent was obtained from patients who participated in this study. Peer-review: Externally peer-reviewed. Author contributions: Concept - R.K.; Design - R.K., S.R., P.T.; Supervision - R.K., P.T., M.A.; Resource - R.K., P.K., K.M.; Materi- als - R.K., P.K., K.M.; Data Collection and/or Processing - R.K., S.R.; Analysis and/or Interpretation - R.K., S.R., P.K.; Literature Search - R.K., R.S., K.M.; Writing - R.K., R.S.; Critical Reviews - P.T., M.A., P.K. Acknowledgements: The authors sincerely thank all patients for their participation in this study, the nursing staff of Institute of Medical Gastroenterology of Madras Medical College and Rajiv Gandhi Government General Hospital for their support and Dr. Breetha Sabarinathan and Dr. Amudhan Aravind towards pre- paring this manuscript. Conflict of Interest: No conflict of interest was declared by the authors. Financial Disclosure: The authors declared that this study has received no financial support. REFERENCES 1. Spaander MC, Baron TH, Siersema PD, et al. Esophageal stenting for benign and malignant disease: European Society of Gastroin- testinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2016; 48: 939-48. [CrossRef] 2. Khara HS, Diehl DL, Gross SA. Esophageal stent fracture: Case report and review of the literature. World J Gastroenterol 2014; 20: 2715-20. [CrossRef] 3. Ferreira F, Bastos P, Ribeiro A, et al. 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