Endoluminal Treatments of Morbid Obesity.pptx

Seminar: Endoluminal Treatments of
Morbid Obesity
-Dr Manu B
27-08-2022 Endoluminal Treatments of Morbid Obesity – Dr Manu 1

ROLE OF ENDOSCOPY
MECHANISM OF WEIGHT
LOSS
INDICATIONS FOR
INTERVENTION
FOLLOW UP
CONCLUSION

PRIMARY /
BRIDGE
REVISION
THERAPY
MANAGEMENT
OF
COMPLICATION

INTRODUCTION

• Obesity - 600 million people worldwide
• Bariatric surgery remains the most effective treatment for
• sustained weight loss and
• improvement of comorbidities
• The steady increase of bariatric procedures each year has led to room for innovation.

• Morbid obesity - cannot be successfully treated with conventional lifestyle interventions such
as
• Diet therapy or
• Increased physical activity
• Due to the tendency for basal metabolic rate to decrease with dieting
• Most people will regain all their weight, returning to the previous homeostatic set point

Rationale for surgery
Bariatric surgery appears to alter this mechanism and ‘reset’ this point, with 15–
25% weight loss maintenance up to 20 years
Bariatric surgery leads to long-term survival benefit and improves obesity-
related disease and quality of life

IFSO survey(Globally) 2017
RYGB 191,326
Sleeve 340,550
Band 19,332
OAGB 30,563
Bariatric surgery - The Gold standard
Protein/calorie
malabsorption
3-year
% EWL
3-year %
diabetes
remission
Gastric band No 40–50% 20%
Gastric bypass No 50–60% 50%
Sleeve
gastrectomy
No 50–60% 50%
BPD/DS Yes 70–80% 80%
4% of bariatric procedures corresponded to endoluminal procedures but this percentage may be
underestimated Angrisani et al. reported.

Estimated early surgical complication rates, operative mortality after gastric banding, gastric bypass
and sleeve gastrectomy and late complications.
Early Mortality Late
Gastric band Access port infection (1%)
DVT/PE (<0.1%)
0.05–0.1% Band infection Tubing
leak Slippage
Erosion into stomach Band
intolerance
Failure to lose weight/weight regain
Gastric bypass Anastomotic leak (<1%)
Intra-abdominal bleed (2–3%)
Unspecified obstruction (1–2%)
DVT/PE (<1%)
0.1–0.2% Internal hernia
Chronic abdominal pain
Malnutrition if long limb bypass
Anastomotic ulcer/stricture
Weight regain
Sleeve gastrectomy Leak at angle of His (2–3%)
Intra-abdominal bleed (2–
3%)
DVT/PE (<1%)
0.1–0.2% Gastro-oesophageal reflux
Weight regain
There is a need for treatment options that reduce surgery related
complications and do not produce a permanent change in the gastrointestinal

MECHANISM OF WEIGHT LOSS
27-08-2022 11

MECHANISM OF WEIGHT LOSS
• Although caloric restriction - dominant mechanism in the early period
• Over the long term - secondary changes in food intake
• Primary caloric restriction
• To the rearrangement of hormonal and neural elements of gastrointestinal tract
• Resulting in
1. Increased satiety
2. Appetite suppression
3. Aversive conditioning due to negative side effects
27-08-2022 12

Incretin theory
GLP-1 glucagon-like
peptide-1
L-cells • Stimulates insulin secretion from the pancreas,
• Increases insulin sensitivity, and
• Inhibits glucagon, thus reducing gluconeogenesis and hepatic
glucose output.
• Glp-1 is also an anorexigenic hormone that acts centrally to
• Increase satiety and reduce appetite
GIP glucagon-
dependent
insulinotropic
polypeptide
K-cells • Antidiabetogenic effects
Postprandial levels of GLP-1 increased significantly and conversely; GIP levels were found to decrease
at 6 months. These findings are similar to the changes in gut hormones post-RYGB

• It is likely that several mechanisms are responsible for the bariatric surgery changes
Negative energy balance and consequent weight loss.
27-08-2022 14
PYY and
GLP-1
Trophic
role of
GLP-2
GIP and
ghrelin

Bariatric surgery
candidate
BMI < 35 AND >=30 BMI < 40 AND >=35 BMI >=40
YES
CONSERVATIVE MANGEMENT
NO NO YES
BARIATRIC/METABOLIC SURGERY
Refractory diabetes or hypertension Comorbidities ?
27-08-2022
16

27-08-2022
BMI ≥ 27 kg/m2 or a
BMI of greater than 25
kg/m2 with
comorbidities
Drug
therapy For patients with BMI of
32.5 kg/m2 in the
presence of
comorbidities and
37.5 kg/m2 in the
absence of co-
morbidities
Bariatric
surgery
BMI : 18.0 – 22.9 Kg/m2
Normal

ROLE OF
ENDOSCOPY

Pre/post Surgery
endoscopy
(EGD) - considered - all patients
With upper GI symptoms
25.3% chance of an unexpected finding that may
alter management or contra-indicate surgery.
Without upper GI symptoms
At 1 year and then every 2– 3 years - LSG or OAGB
• Barrett’s esophagus or
• upper GI malignancy
Follow up after bariatric surgery
EGD should be performed following AGB and RYGB
on the basis of upper GI symptoms
upper GI symptoms

1. Early intervention
IGB - average weight loss of 20% is very inviting…
Brazilian study
BMI Between 25 and 35 Kg/m2
Cardiologists Hypertension associated with obesity
Endocrinologists DM - tried drug treatment with little success
Gynecologists Improvement in fertility
Orthopedists Relief of the musculoskeletal system disorders
Cosmetology Aesthetics
Present day role of Endoluminal therapy

2. Bridge-to-surgery
Mean BMI loss – 7.2
Mean EBL loss - 30.1
190 patients – 183 super obese
76 received subsequent surgery (40.0%)

2. Bridge-to-surgery
3. Primary metabolic treatment to address comorbid illnesses such as diabetes.
41 IU/L 29 IU/L
30 IU/L 23 IU/L

Primary
Endoluminal therapy

8/27/2022 Endoluminal Treatments of Morbid Obesity – Dr Manu 24
Category 1:
Gastric volume reduction - By tissue apposition techniques

EndoCinch
• The EndoCinch product has previously been used to treat GERD.
• Recent - endoluminal gastroplasty by Fogel et al.
• Limiting functional gastric volume.
• Series of stitches are completed,
• The continuous suture is tightened
• Secured with a suture fastening device

• The largest study completed by Fogel et al. was completed in 2009
Fogel et al. 64 patients
Overall (%EWL)
At 1 month 21.1 ± 6.2%
At 3 month 39.6 ± 11.3%
At 12 month 58.1 ± 19.9%

(Overstitch; Apollo Endosurgery)
Reload the suture without the need for removing the endoscope.

• These devices are disposable and are used with standard flexible endoscopes.
• A pilot study of endoluminal gastric plication has been completed using the Restore Suturing
System.
• The proportion of patients with an EWL of or was and, respectively.
• However, the plications were not found to be durable on endoscopic evaluation.
Pilot study of endoluminal gastric plication 21 obese adolescents
At 12 months
Mean weight (−11.0 ± 10.0 kg, P = 0.0006),
Mean BMI (−4.0 ± 3.5 kg/m2, P = 0.0006),
Mean excess weight loss 27.7 ± 21.9%.
proportion of patients with an EWL of
>20% 57%
>30% 50%

SafeStitch
• SafeStitch is currently developing the Intraluminal Gastroplasty Device.
It functions by
1. injecting adrenaline into the mucosa,
2. elevating it for excision,
3. excising the top layer of the entrapped stomach wall,
4. releasing this tissue,
5. removing the device, and
6. tightening the sutures.

TOGA System Deviere et al. and Moreno et al. - Trans-oral gastroplasty
• The TOGA System is a flexible stapler introduced endoscopically.
stapler is fired to approximate the
gastric walls - create a vertical
gastroplasy
The suction chambers- engage
the anterior and posterior gastric
walls
Distend the greater curvature
laterally
serosa-to serosa
apposition

Twenty one patients
were enrolled
BMI 43.3 (35–53)
kg/m2
EWL
at 1 month 16.2%
at three months 22.6%
at 6 months post-
treatment
24.4%
There were no serious adverse events (AEs).
At 6-month endoscopy, all patients had persistent full or partial stapled sleeves.
Gaps in the staple line were evident in 13 patients.
Early experience with the TOGa procedure indicates that this transoral approach may be safe and feasible.

Category 2:
Space-Occupying Devices - Intragastric Baloons

The Rapunzel Syndrome
The concept of weight loss using an intragastric balloon (IGB) originated from the Rapunzel Syndrome
–
• A rare psychiatric condition resulting from trichophagia or ingesting hair.
• The trichobezoar (hairball) occupies the stomach culminating in diminished appetite, postprandial
fullness, and weight loss.
• This concept was used to fill the stomach with a pseudo bezoar – the intragastric balloon, a unique
and innovative supposition to induce weight loss.

BioEnterics Intragastric Balloon/Orbera balloon
• BIB System is a saline-filled space-occupying balloon that is endoscopically placed into the
stomach
Most Studied And widely used
Approved in 2015 by FDA

Overall
complication
70/2,515 (2.8%).
Gstric
perforation
5 patients
(0.19%),
gastric
obstructions
19 (0.76%)
Balloon rupture 9; 0.36%)
Esophagitis (n=32; 1.27%)
and
gastric ulcer (n=5; 0.2%)
Results:
 From May 2000 to September 2004,
2,515 patients After 6 months
mean BMI
44.4±7.8 kg/m2
mean BMI 35.4±11.8 kg/m2 (range 24-73)
%EWL 33.9±18.7 (range 0-87).
Preoperative co-morbidities 1,394/2,471 patients
(56.4%)
resolved 617/1,394 (44.3%)
improved 625/1,394 (44.8%),
unchanged 152/1,394 (10.9%).
Improvement of obesity-related illnesses was significant with regard to fasting
glucose, LDL cholesterol, triglyceride, and blood pressure (P < 0.05).
In 488 diabetes patients, HBA1C level was significantly decreased or normal
in 87.2% (P < 0.05).

ReShape Duo
• The ReShape Integrated Dual Balloon System is an endoscopically placed device consisting
of 2 equal-sized silicone balloons connected by a flexible shaft

ReShape Duo
• Each balloon is filled separately with either 375 or 450 mL of saline + methylene blue
• For a total volume of 750 or 900 mL depending on the height of the patient.
• The device is removed endoscopically at 6 months.
• ReShape Duo 2015 FDA approval.
REDUCE Trial ReShape IGB Diet
Average %EWL
(P = . 004)
25.1% 11.3%

Obalon-Gas Filled Balloon
• Enclosed in a gelatin capsule, which is swallowed by the patient under fluoroscopic
visualization.
• The capsule has an attached catheter that extends through the esophagus and out of the mouth
Pilot Study (Europe) 17 patients
Average EWL at 12 weeks 36%
No serious adverse effect

IGB
device
FDA approval
BMI 30–40 kg/m2
Durat
ion
EWL (%) Premature
removal (%)
SAEs(%) SAEs description
Orbera Approved in 2015 6 • 26.5 at 9 mo
• 22.1 at 12 mo.
18.8 10
Device intolerance,
dehydration, gastric outlet
obstruction, gastric
perforation, pneumonia,
abdominal cramping,
laryngospasm, esophageal
injury
Obalon Approved in 2016 6 23.9 ± 19.2 at 6 mo. 3.3 0.5
Bleeding ulcer and balloon
deflation
ReShape
duo
Approved in 2015 6 27.9±21.3 at 6 mo. 9.1 n.r.
Accomodative symptoms,
esophageal tear,
gastroesophageal junction
ulcer,esophageal
perforation,pneumonitis,
gastric ulceration
Comparision

Spatz -Adjustable Balloon
• Not approved by the FDA but is approved in Europe for 12 months of therapy.
• A study of 73 patients in the United Kingdom showed a 45.7% EWL.

Elipse-Fluid filled swallowed balloon
• Enclosed within a capsule with an attached catheter and swallowed under radiographic
guidance. 550ml fluid & remains in stomach for 4 months.
• Elipse-Fluid filled swallowed balloon
Pilot Study(Elipse-Fluid filled swallowed balloon ) 8 patients
Average EWL at 6 weeks 12.4%
No serious adverse effect

TransPyloric Shuttle
Study 20 participants
mean EWL at 3 months of 25%
mean EWL at 6 months 41%
Complication
Gastric Ulcer 50%
Early removal 2 patients

Balloons - Summary

IGB - contraindications

Category 3:
Malabsorption - Nutrition diversion therapy

DJBL – duodenal jejunal bypass liner
• Preventing chyme from contacting the proximal intestine, similar to the RYGB but without
the gastric restrictive element
• A 60 cm
• Impermeable,
• Fluoropolymer liner
• Anchored in the proximal duodenum

European experience – Multicentre RCT
• There were no major complications.
• Type 2 diabetes mellitus was present at baseline in eight patients of the device group and
improved in seven patients during the study period, as indicated by lower glucose levels,
HbA1c, and medication requirements.
Device group Control
Initial mean BMI 48.9 kg/m2 47.4 kg/m2
Mean excess weight loss after 3
months
19.0% 6.9%
Absolute change in BMI at 3 months 5.5 1.9 kg/ m2
• 30 underwent sleeve
implantation
• 4 devices - explanted
• So total 26 patients
11 patients served as a
diet control group.

(P 0.002) device patients control
(BMI, kg/m2) 48.9 47.4
Mean excess
weight loss after 3
months
19.0% 6.9%
Absolute change
in BMI at 3
months
5.5 1.9
Type 2 diabetes mellitus (8 patients)
improved in 7 patients during the study period (lower
glucose levels, HbA1c, and medication requirements).
Conclusion: The EndoBarrier Gastrointestinal Liner is a feasible and safe noninvasive device with
excellent short-term weight loss results.
The device also has a significant positive effect on type 2 diabetes mellitus.

• The ENDO Trial was a multicenter, double-blinded, and randomised trial
• halted the trial due to the development of 7 liver abscesses (3.5%)
March 2015, the Food and Drug Administration (FDA)

ValenTx - endoscopic duodenal–jejunal sleeve
• ValenTx has developed an endoscopic duodenal–jejunal sleeve that is meant to combine both
gastric restrictive and malabsorptive components

The AspireAssist device used to stimulate weight loss.
(a)Animation of the device when placed in situ.
(b)Endoscopic view of the AspireAssist device. Note the long, wide-bore intragastric tube
to aid in efficient aspiration.
(c) The external portion of the device on the skin showing minimal elevation on the skin.
FDA approves - June 14, 2016
AspireAssist

Clinically significant reductions in glycated hemoglobin (HbA1C), triglycerides, and blood pressure were
observed.
For participants with diabetes, HbA1C decreased by 1% (P < 0.0001) from 7.8% at baseline to 6.8% at 1 year.
Conclusion : This study establishes that aspiration therapy is a safe, effective, and durable weight loss
therapy in people with classes II and III obesity in a clinical setting.
Results
Mean percent total weight loss
1 year 18.2% ± 9.4% (n/N = 155/173)
2 year 19.8% ± 11.3% (n/N = 82/114)
3 year 21.3% ± 9.6% (n/N = 24/43)
4 year 19.2% ± 13.1% (n/N= 12/30)

REVISIONAL
TREATMENT

REVISIONAL TREATMENT
• While Roux-en-Y gastric bypass is considered one of the most effective weight loss procedures,
1. up to 20% of bypass patients will fail to meet success criteria
2. up to 20% of bypass patients will experience significant weight regain
3. (20–35%) in the superobese patients (BMI>50)
A combination of genetic, anatomic, behavioral, and psychological components is thought to contribute to weight
regain in these patients
• Among these, anatomic aspect
• Enlarged gastric pouch,
• Dilated gastrojejunostomy, or both,

• Along with several revision options, endoscopic approaches exist for targeting
this anatomic factor,
1. Endoscopic suturing,
2. Clipping, and
3. Sclerotherapy
• Endoluminal revision of dilated gastrojejunal stomas and dilated gastric pouches
theoretically has a lower risk profile and may provide a solution to some patients
struggling with this problem.

Sclerotherapy
• Sclerotherapy - injection of sclerosant(sodium morrhuate ) in peri-stomal tissue.
• Desired outlet size of less than 12 mm.
• 8–12-week intervals
• 2–3 sessions
• A 2007 study retrospectively 32 patients - 91.6% of patients demonstrated weight
loss
• A subsequent 2008 study involving 71 patients showed that 72% of patients
maintained or lost weight at 12-month follow-up.

Argon plasma coagulation
• APC was performed on patients who regained weight after RYGB procedure.
• A retrospective chart review
• 558 patients at eight bariatric centers
• between 31st July 2009 and 29th March 2017.
• 6–10% total weight loss at 12 months.

• Bard EndoCinch Suturing System - revision of dilated gastrojejunal anastomoses.
• Incisionless Operating Platform (IOP) - revision of dilated gastric pouches and
dilated gastrojejunal stomas.
• Plications are placed around a dilated stoma or within a dilated gastric pouch

• StomaphyX
• Suction for tissue acquisition and
• Delivers polypropylene H-fasteners to secure full thickness plications.
• These plications are created in a circumferential manner in the gastric pouch, thereby reducing
pouch volume
•
Recent study of 39
patients
Average BMI of 39.8
kg/m2
average % EWL
at 1 month 10.6% (n=34)
at 3 month 13.1%
at 6 month 17.0%
At 1 year 19.5%

• OTSC(R)-Clip
An endoscopic over-the-scope clip OTSC - reduce the size of the gastrojejunal
anastomosis.
• Best clinical results were obtained by narrowing the gastrojejunostomy by placing
two clips at opposite sites, thereby reducing the outlet by more than 80%.
Recent study of 94
patients
Average BMI of 32.8
kg/m2
Mean BMI
at 3 month 29.7 kg/m2
At 1 year 27.4 kg/m2

• 25 studies had clear selection criteria for all patients included in their study.
• These are as follows:
• Greater than 18 months following initial bariatric procedure
• Weight regain or failure to lose sufficient weight
• Aged between 18 to 65 years old
• Decreased satiety
• Dilated gastrojejunal anastomosis and gastric pouch
• Increased volume / frequency of meals
• Reappearing comorbidities
• BMI 30–60 kg/m2 greater than six months after RYGB

• Procedures identified
vs Success rate Recurrence rates
Endoluminal plication 91.8% (5.02%) Greatest initial weight
loss within 12 months
post-procedure, but not
sustained at 18
months.
Sclerotherapy & other
techniques
46.8% 21.5% Only one study utilising
sclerotherapy showed
greater sustained
weight loss with peak
EWL (19.9%) at 18
months
Combination therapy EWL (36.4%) at 18 months
Both procedures demonstrate no major complications and low rates of moderate complications.
Only mild complications were noted for combination therapy

Endoscopic management
of
Post-bariatric surgery complications

• Early (< 30 d) complications
• Bleeding and
• Anastomotic leak
• Late (> 30 d) complications.
• Strictures,

Gastrointestinal bleeding
• Immediate postoperative period secondary to technical complications.
• Intra luminal > extraluminal bleeding
Submucosal vessels along the staple line at the
1. Gastrojejunostomy,
2. Jejuno-jejunostomy, or a
3. Long the staple lines of the gastric pouch.

A meta analysis of randomized controlled trials demonstrated efficacy with the use of
several endoscopic therapies, including
1. Thermal therapies (heater probe, mono and bipolar electrocoagulation, argon plasma
coagulation, and laser therapy),
2. Injections with epinephrine and various sclerosants,
3. Clips, and fibrin or thrombin glues.

• Hemostasis was eventually achieved in all patients, but 5 (17%) patients required repeat
endoscopic management for rebleeding
Retrospective study presented by
jamil et al
933 patients that underwent
LRYGB during a 5year study
period
Signs of upper GI bleeding 30
Endoscopic intervention 27
Active oozing 13 (48%)
Visible bleeding vessel 7 (26%)
An adherent clot 7 (26%)
Intervention in 23 patients
Injection with epinephrine (n = 3,
13%)
Heat electrocautery (n = 4, 17%)
Dual therapy with epinephrine and
heat electrocautery (n = 14, 61)
Clips (n = 2, 9%).

Anastomotic leak and fistulas
• Most commonly - along staple lines.
• Overall incidence of anastomotic leak following bariatric surgery is reported to range from
1% to 6%.
• LRYGB - 0.1% to 5.6%
• SG - 2.4%.
Sugery MC site
SG EG junction may be secondary to
stenosis at the incisura.
RYGB GJ anastomosis
duodenal switch ileal staple line

Stent

• Clips
• Leaks postSG - The study concluded that 21 (80.7%) patients were successfully treated with
the OTSC device. Keren et al

• Suturing
• Apollo Overstitch device - full thickness suturing for tissue approximation
• This device has been implicated in the early use of closure of fistulas.
• Fibrin glue or sealant
• Hemostatic and
• Sealant with tissue adhesive capabilities.
• Fibrin glue is composed of fibrinogen and thrombin.
Fibrin glue is rarely used a single modality but rather in combination with endoscopic stenting.

Management of strictures:
• Strictures incidence
• post LRYGB - 3% - 28%.
• SG - 0.2% to 4%.
• It is important to differentiate true stenosis from sleeve rotation or torsion which may mimic
obstructive symptoms.
• This may also be managed through endoscopic dilation, myotomy or surgical revision.

• Endoscopic balloon dilation has become first-line treatment and standard of
care for the management of strictures post LRYGB.
• Management of strictures post SG includes
1. Observation,
2. Endoscopic dilation with or without stenting,
3. Seromyotomy, or
4. Ultimately converting to a LRYGB.

Stenting:
• Stenting rarely used in the management of strictures.
• 83% stent success rate in managing strictures in six patients that had been refractory to
repeated balloon dilations. Eubanks et al
• Common concern of stent application is stent migration - 58% to 66%

Summary of British Obesity and Metabolic Surgery Society (BOMSS)
After Gastric Banding, Sleeve gastrectomy:
Annual full blood count, urea and electrolytes, HbA1c, fasting glucose, lipids as appropriate
After Gastric bypass, BPD/DS:
As for bands +
1. Liver function tests, ferritin, folate, vitamin D, ca++, parathyroid hormone at 3, 6, 12 months then
annually;
2. Vitamin B12 at 6, 12 months then annually;
3. Zinc, copper - annual;
4. Vitamin A, E, K, selenium if concern (e.G. Steatorrhoea, night blindness, unexplained fatigue,
anaemia, metabolic bone disease, chronic diarrhoea, heart failure)
27-08-2022 77

27-08-2022 78
Summary of British Obesity and Metabolic Surgery Society (BOMSS)
nutritional and micronutrient guidance after bariatric surgery.
After gastric banding:
Multivitamin and mineral supplement, thiamine if vomiting, vitamin D, iron
After gastric bypass, sleeve gastrectomy, BPD/DS:
As for banding + selenium, copper, zinc, folic acid, vitamins B12, A, E, K (BPD/DS may
require higher doses)

• Endoscopy - Clearly defined Role in:
• Pre op evaluation
• Post of follow up
• Managing post surgery complication
• As primary/revision treatment – Promising/minimally invasive/without permanently
changing the anatomy
• An excellent adjunctive strategy
• Bridge therapy in super obese
• Delay revision surgeries
CONCLUSION

• There are still many questions regarding the
1. Relative efficacy and
2. Durability of these procedures,
3. As well as their place within bariatric and endoluminal surgery.
• Finally, it is imperative that gastroenterologists and bariatric surgeons work together
within a multidisciplinary culture and structure to ensure safe adoption of these new
techniques.
CONCLUSION

Thank you

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