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Lo Stent nelle
Occlusioni Neoplastiche
del Colon
Guido Costamagna
Catholic University – “A. Gemelli” Hospital
European Endoscopy Training Center (EETC)
Rome - Italy
Colorectal Cancer
Obstruction
Presenting
symptom in
8-29% of cases
1991: Esophageal Stents sporadically
used for palliation in CRC obstruction

1991
First (esophageal) stent
implantation
for palliative treatment
Dohmoto M, Rupp KD (1991)
Dtsch Med Wochenschr 115: 943
Esophageal vs Colorectal
Wall Thickness

5-6 mm
3-4 mm
Esophageal vs Colorectal
Lumen
2000: Specifically designed
Colorectal Stents
Indications
to Colorectal Stents
Bridge to Surgery


Acute colonic obstruction
Palliation



CR cancer stage IV patients



Unresectable extracolonic neoplasms



Patients unfit for surgery



Patients who refuse colostomy
Literature on CRC and Stents


Multiple retrospective studies



Variability in case-mix



Selection biases





Shortcomings of the published literature

Vast heterogeneity in the technical
success rates and risk profiles

5 RCT’s
CRC and Stents in 2013

Still No Evidence Based !
Endoscopic Treatment
of Advanced CR Carcinoma

Bridge-to-Surgery
Bridge-to-Surgery
Rationale



To avoid emergency surgery



Allow normal preoperative bowel preparation
followed by a one-stage elective procedure



Allows time for resuscitation, re-hydration, and
hyper-alimentation



To decrease the rate of stoma formation



Overall lower morbidity and mortality



If Stage IV  Palliation
Bridge-to-Surgery
Emergency
surgery

vs

Elective
surgery

Morbidity 10% - 36%

Morbidity 4% - 14%

Mortality 6% - 38%

Mortality 1% - 13%

Often 2-stage procedure with
temporary colostomy
Colostomy reversal only in 60%
Colostomy associated with
morbidity and QoL implications
Data from Literature
Malignant Colonic Obstruction:
Literature Review on CR Stents
(1992-2004)

54 Series*
1198 Pts
Palliation

Bridge to Surgery

791 (66%)

407 (34%)

* Technique:
Endo-Rx
Rx
Endo

37
16
1
Sebastian. Am J Gastroenterol 2004; 99: 2051-57
Literature Review on Bridge to Surgey
Technical Success
91.9%
Clinical Success
78.1%*
*Causes of clinical failure:
• Locally advanced tumor
• Poor preparation
• Stent migration
• Perforation
Am J Gastroenterol 2004
Bridge to Surgery vs Emergency Surgery:
Long-Term Prognosis
Early complications
14%
12%
10%

P<0.05

8%

Emerg. Surg.
Stent

6%
4%
2%
0%

Infections

Anast. Leak

Saida et Al. Dis Colon Rectum 2003
Bridge to Surgery vs Emergency Surgery:
Long-Term Prognosis
Survival rate

40%

5 years
fu

44%

48%
3 years

0%

Emerg. Surg.
Stent

50%

20%

40%

60%

Saida et Al. Dis Colon Rectum 2003
Cost Analysis of
Bridge to surgery
vs 2-stage surgical procedure
6000

Cost in GBP (£)

5000

Bridge to surgery
and elective resection
(n=5)

4000
3000

Hartmann’s operation
and reversal
(n = 6)

2000
1000
0
Hospital Stent
stay

Material Theatre/
(excl. radiology
stent)
suite

Total

Osman H.S. et al. Colorectal Dis 2000
2002: A role for Lap Surg
Malignant colonic obstruction managed by
endoscopic stent decompression
followed by laparoscopic resection

Morino et Al. Surg Endosc 2002
Endoscopic Treatment
of Advanced CR Carcinoma

Palliation
From: Incidence and Predictors of Bowel Obstruction in Elderly Patients With Stage IV Colon Cancer: A
Population-Based Cohort Study
JAMA Surg. 2013;148(8):715-722. doi:10.1001/jamasurg.2013.1

Copyright © 2012 American Medical
Association. All rights reserved.
Effect of primary tumor resection on
survival in CRC stage IV Patients
Palliative Surgery vs CR Stenting
Palliative resection of primary CRC
should be pursued in stage IV patients,
as this prolongs survival
In these pts new schedules of chemotherapy
has improved the median survival
from around 11 months with conventional regimes
to over 20 months with the new ones
Cochrane Database Syst Rev 2000
Costi R et al. Ann Surg Oncol 2007
Konyalian VR et al. Colorectal Dis 2007
Malignant Colonic Obstruction:
Literature Review on CR Stents
Technical Success
93.2%
CR tumors
93.5%

Extrinsic group
78%

Am J Gastroenterol 2004; 99: 2051-57
Stents for
Colonic vs Extracolonic Malignancy
Colon stenting for large-bowel obstruction from
ECM is seldom successful and is associated
with a significantly higher risk of complications in
comparison with patients with CRC

Keswani RN. Gastrointest Endosc 2009
Malignant Colonic Obstruction:
Literature Review on CR Stents

Clinical Success
88.5%

Am J Gastroenterol 2004; 99: 2051-57
Malignant Colonic Obstruction:
Literature Review on CR Stents

Complications


Stent Migration

11.8%



Re-obstruction

7.3%



Perforation

3.7%



Mortality

0.6%
Am J Gastroenterol 2004
Colonic perforation after stent placement for malignant
colorectal obstruction – causes and contributing factors
Datye A, Hersh J. Minim Invasive Ther Allied Technol. 2011

2287 pts from 82 articles
Overall perforation rate: 4.9%
Perf rates for P and BTS not significantly different
(4.8% vs. 5.4%, p = 0.66);
Over 80% of perf occurred within 30 days of stent
placement
Mortality rate related to perforation: 0.8%
Mortality of patients with perforation: 16.2%.
No significant difference (p = 0.78) in the mortality
rates between the P and the BTS group

Premature Closure of the
Dutch Stent-in I Study

Multi -centre, prospective, randomised
controlled trial WallFlex stent VS surgery
in patients with incurable CRC

Study stopped by the Safety Monitoring Committee
21 patients included.
10 patients treated with stenting.
Hooft EJ and Dutch Stent-in Study Group. Endoscopy 2008
Premature Closure of the
Dutch Stent-in I Study

60% Perforation Rate !
Hooft EJ and Dutch Stent-in Study Group. Lancet 2006
Premature Closure of the
Dutch Stent-in I Study

Of the seven stented patients who were treated
with chemotherapy, four developed a (late) perforation
Hooft EJ and Dutch Stent-in Study Group. Lancet 2006
The 11.1% mortality following colonic stenting
for obstructing cancers
was higher than in published cases
and may need further study
The Association of Coloproctology of Great Britain and Ireland
Palliative SEMS:
Look Out for Perforations !

3/19 pts (16%)
died within a week after the insertion
of an Ultraflex Precision Stent
Surg Laparosc Endosc Percutan Tech, 2008
CR stents in palliative situation


Complications rates*: 25 - 50 %


Perforation :



Obstruction :



Migration :
5-20 %



5-10 %

Ulceration :
<5%

10-15 %

* 50% of complications are observed after the 1st week
Ceze, JFHOD 2007
Fernandez-Esparrach, Am J Gastro 2010
Small, GIE 2011
CR Stents: Risk of Perforation
Risk factors for perforation


Chemotherapy



Steroids



Radiotherapy

Datye A, Hersh J. Minim Invasive Ther Allied Technol. 2011
Stents vs Surgery: 5 RCT’s
van Hooft JE
Lancet 2006
van Hooft JE
Lancet Oncology 2011
Pirlet IA
Surgical Endoscopy 2011
Alcántara M
World Journal of Surgery 2011
Ho KS
International Journal of Colorectal Disease 2012
Stents vs Surgery: 5 RCT’s


Four were interrupted by the respective
ethics committee:






One for the high incidence of perforations
(6/11)
Other two for the high perforation rate (13%
and 6.6%), and for the lack of benefit with
regard to quality of life and stoma formation.
Only the Study of Alcantara has been
discontinued for the high rate of anastomotic
dehiscence in one-stage surgery
… consider placing a SEMS
to initially manage a left-sided
complete or near-complete
colonic obstruction
Only a healthcare
professional experienced in
placing colonic stents who
has access to fluoroscopic
equipment and trained
support staff should insert
colonic stents
If a SEMS is suitable attempt
insertion urgently and no
longer than 24 hours after
patients present with colonic
obstruction.
• Systematic review of five RCTs
• Higher rates of clinical relief of obstruction in
emergency surgery
• CR stent has not been shown to be as effective as
emergency surgery in malignant colorectal
obstructions
• Use of CR stent is associated with comparable
mortality and morbidity with advantage of shorter
hospital stay and procedure time and less blood loss.
“Colonic stenting has no decisive advantages
to Emergency surgery”

Sagar Jayesh
Colorectal stents for the management of malignant colonic obstructions
39
Cochrane Database of Systematic Reviews. 2011
UK ColoRectal Stenting Trial (CReST)
2009 –






Pts in emergency setting
with left-sided neoplastic colonic obstruction
who require urgent decompression
Randomised to

Stenting
Stenting

Surgical decompression
Surgical decompression
+/+/Resection
Resection
To Stent or Not to Stent
That Is the Question
The question of stenting, therefore, remains
unanswered.
It seems a reasonable approach for patients with
incurable cancer who have a left-sided obstruction
or those who are not fit for an operation.
Questions arise as to the need for stents as a
bridge to surgical intervention given the high rate of
stoma formation despite decompression with a
stent.
Any risk of perforation in a patient with a potentially
curable obstruction is not acceptable because it
converts a curable obstruction into one destined for
Possible worsening of QoL
even after a successful SEMS insertion






… An elderly woman who presented with an
obstructing metastatic rectal cancer
underwent ‘successful’ insertion of SEMS and
was subsequently managed by the palliative
care team.
She died peacefully after 6 months …
The twist of the story was that she spent her
remaining days mostly on the toilet as the
stent made her incontinent…
D. Debnath. Br J Surg 2004
Stent Palliation of
Malignant Colonic Obstruction

Bowel function is often poor in patients
treated with CR stents
 Functional outcome should be
discussed fully during the consenting
process for the procedure.


Colorectal Disease 2006, 7
Contraindications
to Colorectal Stents


Long Life Expectancy



Right sided occlusions



Incomplete occlusion



Cancers ≤ 5 cm from the anal verge



Severe anemia by bleeding cancers



(Extracolonic Malignancies)
• The decision to insert a SEMS or to perform a

colostomy involves multiple areas of uncertainty…

• The longer a SEMS remains in place, the

greater the amount of uncertainty surrounding its
effectiveness and the higher the probability that
surgery is the preferred alternative
da Silveira E, Barkun AN.
Gastrointest Endosc. 2008.
• Utilization of SEMS for conditions that have not

been thoroughly investigated (ie, long-term
palliation of CRC) cannot be recommended yet ...

• … but short ‘‘bridges’’ from acute obstruction to
surgery can be safely ‘‘crossed’’ with the
endoscopic insertion of a colonic SEMS

da Silveira E, Barkun AN.
Gastrointest Endosc. 2008.
Stent Palliation of
Malignant Colonic Obstruction
Take Home Messages


Acute Occlusion = Bridge to Surgery



Palliation: Stent only if occlusion



If CT planned, consider resection



Discuss with the patient
(Informed Consent)

!

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Lo stent nelle occlusioni neoplastiche del Colon - Gastrolearning®

  • 1. Lo Stent nelle Occlusioni Neoplastiche del Colon Guido Costamagna Catholic University – “A. Gemelli” Hospital European Endoscopy Training Center (EETC) Rome - Italy
  • 3. 1991: Esophageal Stents sporadically used for palliation in CRC obstruction 1991 First (esophageal) stent implantation for palliative treatment Dohmoto M, Rupp KD (1991) Dtsch Med Wochenschr 115: 943
  • 4. Esophageal vs Colorectal Wall Thickness 5-6 mm 3-4 mm
  • 7. Indications to Colorectal Stents Bridge to Surgery  Acute colonic obstruction Palliation  CR cancer stage IV patients  Unresectable extracolonic neoplasms  Patients unfit for surgery  Patients who refuse colostomy
  • 8. Literature on CRC and Stents  Multiple retrospective studies   Variability in case-mix  Selection biases   Shortcomings of the published literature Vast heterogeneity in the technical success rates and risk profiles 5 RCT’s
  • 9. CRC and Stents in 2013 Still No Evidence Based !
  • 10. Endoscopic Treatment of Advanced CR Carcinoma Bridge-to-Surgery
  • 11. Bridge-to-Surgery Rationale  To avoid emergency surgery  Allow normal preoperative bowel preparation followed by a one-stage elective procedure  Allows time for resuscitation, re-hydration, and hyper-alimentation  To decrease the rate of stoma formation  Overall lower morbidity and mortality  If Stage IV  Palliation
  • 12. Bridge-to-Surgery Emergency surgery vs Elective surgery Morbidity 10% - 36% Morbidity 4% - 14% Mortality 6% - 38% Mortality 1% - 13% Often 2-stage procedure with temporary colostomy Colostomy reversal only in 60% Colostomy associated with morbidity and QoL implications Data from Literature
  • 13. Malignant Colonic Obstruction: Literature Review on CR Stents (1992-2004) 54 Series* 1198 Pts Palliation Bridge to Surgery 791 (66%) 407 (34%) * Technique: Endo-Rx Rx Endo 37 16 1 Sebastian. Am J Gastroenterol 2004; 99: 2051-57
  • 14. Literature Review on Bridge to Surgey Technical Success 91.9% Clinical Success 78.1%* *Causes of clinical failure: • Locally advanced tumor • Poor preparation • Stent migration • Perforation Am J Gastroenterol 2004
  • 15. Bridge to Surgery vs Emergency Surgery: Long-Term Prognosis Early complications 14% 12% 10% P<0.05 8% Emerg. Surg. Stent 6% 4% 2% 0% Infections Anast. Leak Saida et Al. Dis Colon Rectum 2003
  • 16. Bridge to Surgery vs Emergency Surgery: Long-Term Prognosis Survival rate 40% 5 years fu 44% 48% 3 years 0% Emerg. Surg. Stent 50% 20% 40% 60% Saida et Al. Dis Colon Rectum 2003
  • 17. Cost Analysis of Bridge to surgery vs 2-stage surgical procedure 6000 Cost in GBP (£) 5000 Bridge to surgery and elective resection (n=5) 4000 3000 Hartmann’s operation and reversal (n = 6) 2000 1000 0 Hospital Stent stay Material Theatre/ (excl. radiology stent) suite Total Osman H.S. et al. Colorectal Dis 2000
  • 18. 2002: A role for Lap Surg Malignant colonic obstruction managed by endoscopic stent decompression followed by laparoscopic resection Morino et Al. Surg Endosc 2002
  • 19. Endoscopic Treatment of Advanced CR Carcinoma Palliation
  • 20. From: Incidence and Predictors of Bowel Obstruction in Elderly Patients With Stage IV Colon Cancer: A Population-Based Cohort Study JAMA Surg. 2013;148(8):715-722. doi:10.1001/jamasurg.2013.1 Copyright © 2012 American Medical Association. All rights reserved.
  • 21. Effect of primary tumor resection on survival in CRC stage IV Patients Palliative Surgery vs CR Stenting Palliative resection of primary CRC should be pursued in stage IV patients, as this prolongs survival In these pts new schedules of chemotherapy has improved the median survival from around 11 months with conventional regimes to over 20 months with the new ones Cochrane Database Syst Rev 2000 Costi R et al. Ann Surg Oncol 2007 Konyalian VR et al. Colorectal Dis 2007
  • 22. Malignant Colonic Obstruction: Literature Review on CR Stents Technical Success 93.2% CR tumors 93.5% Extrinsic group 78% Am J Gastroenterol 2004; 99: 2051-57
  • 23. Stents for Colonic vs Extracolonic Malignancy Colon stenting for large-bowel obstruction from ECM is seldom successful and is associated with a significantly higher risk of complications in comparison with patients with CRC Keswani RN. Gastrointest Endosc 2009
  • 24. Malignant Colonic Obstruction: Literature Review on CR Stents Clinical Success 88.5% Am J Gastroenterol 2004; 99: 2051-57
  • 25. Malignant Colonic Obstruction: Literature Review on CR Stents Complications  Stent Migration 11.8%  Re-obstruction 7.3%  Perforation 3.7%  Mortality 0.6% Am J Gastroenterol 2004
  • 26. Colonic perforation after stent placement for malignant colorectal obstruction – causes and contributing factors Datye A, Hersh J. Minim Invasive Ther Allied Technol. 2011 2287 pts from 82 articles Overall perforation rate: 4.9% Perf rates for P and BTS not significantly different (4.8% vs. 5.4%, p = 0.66); Over 80% of perf occurred within 30 days of stent placement Mortality rate related to perforation: 0.8% Mortality of patients with perforation: 16.2%. No significant difference (p = 0.78) in the mortality rates between the P and the BTS group 
  • 27.
  • 28. Premature Closure of the Dutch Stent-in I Study Multi -centre, prospective, randomised controlled trial WallFlex stent VS surgery in patients with incurable CRC Study stopped by the Safety Monitoring Committee 21 patients included. 10 patients treated with stenting. Hooft EJ and Dutch Stent-in Study Group. Endoscopy 2008
  • 29. Premature Closure of the Dutch Stent-in I Study 60% Perforation Rate ! Hooft EJ and Dutch Stent-in Study Group. Lancet 2006
  • 30. Premature Closure of the Dutch Stent-in I Study Of the seven stented patients who were treated with chemotherapy, four developed a (late) perforation Hooft EJ and Dutch Stent-in Study Group. Lancet 2006
  • 31. The 11.1% mortality following colonic stenting for obstructing cancers was higher than in published cases and may need further study The Association of Coloproctology of Great Britain and Ireland
  • 32. Palliative SEMS: Look Out for Perforations ! 3/19 pts (16%) died within a week after the insertion of an Ultraflex Precision Stent Surg Laparosc Endosc Percutan Tech, 2008
  • 33. CR stents in palliative situation  Complications rates*: 25 - 50 %  Perforation :  Obstruction :  Migration : 5-20 %  5-10 % Ulceration : <5% 10-15 % * 50% of complications are observed after the 1st week Ceze, JFHOD 2007 Fernandez-Esparrach, Am J Gastro 2010 Small, GIE 2011
  • 34. CR Stents: Risk of Perforation Risk factors for perforation  Chemotherapy  Steroids  Radiotherapy Datye A, Hersh J. Minim Invasive Ther Allied Technol. 2011
  • 35.
  • 36. Stents vs Surgery: 5 RCT’s van Hooft JE Lancet 2006 van Hooft JE Lancet Oncology 2011 Pirlet IA Surgical Endoscopy 2011 Alcántara M World Journal of Surgery 2011 Ho KS International Journal of Colorectal Disease 2012
  • 37. Stents vs Surgery: 5 RCT’s  Four were interrupted by the respective ethics committee:    One for the high incidence of perforations (6/11) Other two for the high perforation rate (13% and 6.6%), and for the lack of benefit with regard to quality of life and stoma formation. Only the Study of Alcantara has been discontinued for the high rate of anastomotic dehiscence in one-stage surgery
  • 38. … consider placing a SEMS to initially manage a left-sided complete or near-complete colonic obstruction Only a healthcare professional experienced in placing colonic stents who has access to fluoroscopic equipment and trained support staff should insert colonic stents If a SEMS is suitable attempt insertion urgently and no longer than 24 hours after patients present with colonic obstruction.
  • 39. • Systematic review of five RCTs • Higher rates of clinical relief of obstruction in emergency surgery • CR stent has not been shown to be as effective as emergency surgery in malignant colorectal obstructions • Use of CR stent is associated with comparable mortality and morbidity with advantage of shorter hospital stay and procedure time and less blood loss. “Colonic stenting has no decisive advantages to Emergency surgery” Sagar Jayesh Colorectal stents for the management of malignant colonic obstructions 39 Cochrane Database of Systematic Reviews. 2011
  • 40. UK ColoRectal Stenting Trial (CReST) 2009 –     Pts in emergency setting with left-sided neoplastic colonic obstruction who require urgent decompression Randomised to Stenting Stenting Surgical decompression Surgical decompression +/+/Resection Resection
  • 41. To Stent or Not to Stent That Is the Question The question of stenting, therefore, remains unanswered. It seems a reasonable approach for patients with incurable cancer who have a left-sided obstruction or those who are not fit for an operation. Questions arise as to the need for stents as a bridge to surgical intervention given the high rate of stoma formation despite decompression with a stent. Any risk of perforation in a patient with a potentially curable obstruction is not acceptable because it converts a curable obstruction into one destined for
  • 42. Possible worsening of QoL even after a successful SEMS insertion    … An elderly woman who presented with an obstructing metastatic rectal cancer underwent ‘successful’ insertion of SEMS and was subsequently managed by the palliative care team. She died peacefully after 6 months … The twist of the story was that she spent her remaining days mostly on the toilet as the stent made her incontinent… D. Debnath. Br J Surg 2004
  • 43. Stent Palliation of Malignant Colonic Obstruction Bowel function is often poor in patients treated with CR stents  Functional outcome should be discussed fully during the consenting process for the procedure.  Colorectal Disease 2006, 7
  • 44.
  • 45. Contraindications to Colorectal Stents  Long Life Expectancy  Right sided occlusions  Incomplete occlusion  Cancers ≤ 5 cm from the anal verge  Severe anemia by bleeding cancers  (Extracolonic Malignancies)
  • 46. • The decision to insert a SEMS or to perform a colostomy involves multiple areas of uncertainty… • The longer a SEMS remains in place, the greater the amount of uncertainty surrounding its effectiveness and the higher the probability that surgery is the preferred alternative da Silveira E, Barkun AN. Gastrointest Endosc. 2008.
  • 47. • Utilization of SEMS for conditions that have not been thoroughly investigated (ie, long-term palliation of CRC) cannot be recommended yet ... • … but short ‘‘bridges’’ from acute obstruction to surgery can be safely ‘‘crossed’’ with the endoscopic insertion of a colonic SEMS da Silveira E, Barkun AN. Gastrointest Endosc. 2008.
  • 48. Stent Palliation of Malignant Colonic Obstruction Take Home Messages  Acute Occlusion = Bridge to Surgery  Palliation: Stent only if occlusion  If CT planned, consider resection  Discuss with the patient (Informed Consent) !

Editor's Notes

  1. Cumulative incidence of hospitalization for bowel obstruction over time in the baseline cohort of 12 553 patients with stage IV colon cancer in the Surveillance, Epidemiology, and End Results and Medicare claims linked databases for January 1, 1991, through December 31, 2005, stratified by tumor histological type. For reference, the median survival of each group is given. We found no significant difference in survival experience by histological type (P = .29) in a multivariable model of survival since the cancer diagnosis that included age at and year of diagnosis, sex, marital status, patient comorbidity score, primary tumor surgery, chemotherapy after diagnosis, tumor site and grade, and lymph node status. IQR indicates interquartile range.