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Endoscopic Management Of
Obesity
(Endobariatrics)
Dr.Santosh M Narayankar
Department Of Gastroenterology
Yashoda Hospital
Bridge the gap between medical therapy
& surgical management.
• It may be used as
Primary Therapy
Bridging Procedure
Revisional Procedure
• Preoperative Endoscopy
• Post Operative Endoscopic
Management Of Surgical
Complications
• Endoscopic Treatment Of Obesity
PRIMARY THERAPY
• Intra Gastric Balloons
• Tissue Apposition Techniques
• Nutrient Diverting Therapies
Secondary Therapy
• Trans oral outlet reduction
• Revision Obesity Surgery Endoscopic
• Argon Plasma Coagulation
INTRAGASTRIC
BALLOONS
Intra Gastric Balloons
• Orbera Balloon –Fluid Filled
• Reshape Duo –Fluid Filled
• Spatz Ballon-Fluid Filled Adjustable
• Obalon Balloon-Gas Filled
• Elipse Balloon-Fluid filled
• TransPyloric Shuttle
FDA Approved in 2015-ReShape and Orbera
Orbera Balloon
• Most Studied And widely used –
Introduced in 1991
• Single,Spherical & made of silicone
• Placed Endoscopicaly
• Inflated with 400-700ml saline+2 to 10ml
Methylene blue
• Approved in 2015 by FDA
• The ASGE Bariatric Endoscopy Task Force
systematically reviewed 82 studies in 2015.
• These patients averaged a 25.4% EWL, with
a 95% confidence interval (CI) of 21.5% to
29.4%.
• Only 3 studies had adequate control
groups, with Orbera patients losing an
average of 26.9% more weight than control
patients , with 95% CI of 15.6% to 38.2%.
• A large RCT-results have not yet been
published
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
• 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 was approved by the FDA for
treatment of obesity in 2015.
ReShape Duo
• The ReShape IGB was evaluated in the
REDUCE Trial
• The completed study At 24 weeks, Duo
subjects had an average %EWL of 25.1%
compared with 11.3% in Diet patients(P= .
004) on intention-to-treat analysis.
• An average of 66% of weight lost at time of
balloon removal was maintained 24 weeks
later.
• Endoscopically placed, saline-filled single
intragastric balloon.
• Attached inflation tube -extracted out
through the mouth to adjust the balloon
volume during therapy to improve tolerance
or efficacy.
• Not approved by the FDA but is approved in
Europe for 12 months of therapy.
Spatz -Adjustable Balloon
Spatz Adjustable Balloon
• At present, there are limited safety and
efficacy data on the Spatz IGB.
• A study of 73 patients in the United
Kingdom showed a 45.7% EWL.
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, and is used to inflate the balloon with
250 mL of a nitrogen-mix gas.
Obalon-Gas Filled Balloon
• Pilot study - 17 patients was undertaken in
Europe, with up to 3 balloons given per patient,
swallowed individually at 4-week intervals, and
removed endoscopically at 12 weeks.
• Average EWL at 12 weeks was 36%, with no
serious adverse events reported.
• Most patients experienced transient abdominal
pain and nausea after balloon administration
Obalon-Gas Filled Balloon
• Enclosed within a capsule with an attached
catheter and swallowed under radiographic
guidance.
• 550ml fluid & remains in stomach for 4
months.
• Degrades over 4 months.
Elipse-Fluid filled swallowed
balloon
Elipse-Fluid filled swallowed
balloon
• An 8-patient pilot study using a
prototype demonstrated no adverse
events and patients lost an average of
12.4% of excess weight over 6 weeks.
• Results of a small multicenter study ,
yet to be published.
Elipse-Fluid filled swallowed
balloon
TransPyloric Shuttle
• Consists of a spherical bulb attached by a
flexible cord to a smaller cylindrical bulb
• Placed endoscopically and assembled in the
stomach.
• The large bulb rests in the antrum, with the
smaller bulb crossing into the duodenum.
• Intermittent obstruction at the pylorus leading
to delayed gastric emptying and longer periods
of satiety.
• One study of 20 participants showed
promising results, with mean EWL of 25%
at 3 months and 41% at 6 months
• Gastric ulcers in 50% of patients with
early device removal in 2 patients due to
symptomatic gastric ulcers.
• The ENDObesity II multicenter study is
currently underway, with no results yet
published.
TransPyloric Shuttle
Tissue Apposition
Techniques
• Gastric volume is reduced by using
endoscopically placed sutures to create a
gastric sleeve similar to a sleeve gastrectomy.
Endoscopic Sleeve
Gastroplasty
Overstitch endoscopic suturing device
(Apollo Endosurgery),an FDA-approved
commercial device for the purposes of tissue
apposition compatible with a double-channel
therapeutic gastroscope
• In 2015, midterm results of an open-label trial
were reported, with 25 patients (BMI 35.5)
enrolled.
• All ESGs remained intact by endoscopic
evaluation at 3 months, and patients had lost
an average of41%of excess body weight at 20
months
Endoscopic Sleeve
Gastroplasty
Primary Obesity Surgery
Endoluminal(POSE)
• Over tube style incision less operating platform (USGI
Medical, San Clemente, California) with 4working
channels and accommodates a slim endoscope along
with specialized instruments that are FDA-approved
for tissue apposition
• Transmural tissue anchor plications –
• To reduce accommodation of the gastric fundus
• Additional plications in the distal gastric body to delay
emptying.
Primary Obesity Surgery
Endoluminal
• Feasibility and safety were demonstrated in
a single-center , open-label prospective trial
in Spain with 45 patients evaluated, with
49% EWL average at 6 months.
• Physiologic changes –
• Decreased intake capacity
• Initially delayed gastric emptying that returned to
baseline by 6 months
• Improved insulin sensitivity
• Enhanced postprandial decrease in ghrelin.
ESSENTIAL, MILEPOST
Results have been presented in abstract form, but have not been published
Nutrient Diversion
Therapy
Aspiration therapy
• New endoscopic approach - Placement of a
large per cutaneous silicone gastrostomy tube
(A-Tube) that is subsequently connected with
a skin port to an Aspire Assist device (Aspire
Bariatrics, King of Prussia, Pennsylvania)
• The patient uses this system to siphon off a
portion of the ingested meal, typically one-
third of the volume.
Aspiration therapy
• In a small pilot study published in 2013,
patients in the aspiration group lost an
average of 49% of excess weight, compared
with 14.9% in the lifestyle therapy group.
Weight loss was maintained at 2-year follow-
up.
• No serious adverse effects were observed, and
no binge eating episodes occurred.
• Similar results were obtained in a single-arm
prospective trial in Sweden.
Duodenal–Jejunal Bypass
Liner
• Endobarrier (GI Dynamics, Lexington,
Massachusetts) is a 65 cm Teflon sleeve
that is anchored in the duodenal bulb by a
barbed nitinol crown .
• The device is placed under endoscopic and
fluoroscopic guidance.
• Removed endoscopically at 12 months.
EndoBarrier
• Efficacy has been assessed over several
studies, with EWL ranging from 30% to47%
at 52 weeks.
• A recent meta-analysis found that patients
had an average of 12.6% EWL with
EndoBarrier compared to dietary
modification, with an average of 0.9% change
in HbA1c that failed to meet statistical
significance
Gastroduodenal Bypass Liner
• Long 120 cm fluoropolymer sleeve has been
developed (ValenTx, Hopkins, Minnesota) .
• Secured at the GE junction - Endoscopic +
Laparoscopic approach.
• The device bypasses the stomach, duodenum,
and proximal jejunum.
• It is also left in place for 12 months and
retrieved endoscopically.
Gastroduodenal Bypass Liner
• A 1-year prospective series with 12 patients
enrolled showed an average EWL of 35.9%.
• 2 patients had the device removed due to
dysphagia and odynophagia, and 4 patients
had partially detached devices at 12 months,
with inferior weight loss results.
• No bowel erosions, ulcerations, or cases of
pancreatitis were observed.
• A modification device - does not require
laparoscopic assistance is being developed.
Incisionless Anastomosis System
• Endoscopically deliver magnets to adjacent
GI lumens, creating entero-enteral bypass
anastomoses by magnetic compression.
• IAS(GI Windows,Boston, Massachusetts),
previously known as self-assembling magnets
for endoscopy (SAMSEN), consists of smart
magnets that are delivered endoscopically in
a linear configuration and form an octagonal
shape intra luminally
Incisionless Anastomosis
System
• For bariatric use, this device may induce
ileal break with decreased food intake and
improved diabetic control.
• This system has recently been evaluated
in people in a feasibility study in Europe,
but the results have not been published
yet.
Incisionless Anastomosis System
Mucosal Resurfacing
• The Revita duodenal mucosal resurfacing procedure
(Fractyl Laboratories, Cambridge,Massachusetts)
• Involves the use of RFA following saline lift to induce
mucosal remodeling .
• Result in changes in enteroendocrine cells improving
diabetic control.
• A pilot study has been completed, and a multicenter
clinical trial is currently underway in Europe.
Mucosal Resurfacing-Revita
catheter
Secondary Therapy
Transoral Outlet Reduction
• Endoscopic Suturing technique
• Endoclinch
• Apollo Overstictch
• Associated - Decreased incidence of
• Dumping syndrome
• Bile reflux &
• Weight regain.
Revision Obesity Endoscopic
Surgery(ROSE)
• Uses the Incisionless Operating Platform
(IOP, USGI Medical) to place durable tissue
anchors in the gastric lumen to create
placations.
• In 2009, a multicenter prospective single- arm study of 116
patients ,reported 69% of patients experienced increased
satiety; 88% of patients stopped weight regain at 6 months,
and 53% of patients achieved an EWL of at least 20%, with
a mean 11.3 kg weight loss at 6 months. No significant
complications occurred
Argon Plasma Coagulation
• Used with 65 to 75 W and 2-3 L/m flow can be
used on the mucosa in the GJ anastomosis.
• Leading to fibrosis of gastric mucosa and
subsequent reduction of the GJ stoma.
• In a study of 215 patients by Sander and
colleagues , APC was used to decrease the
diameter of the GJ stoma by almost 50%
using an average of 1.36 sessions.
• Patients experienced on average 13.8 kg weight
loss after the final APC session.
• However, 69 patients (32.1%) did not achieve the
target stoma diameter.
• Main complication - Symptomatic stenosis in
16.3% of patients, necessitating balloon dilation.
Argon Plasma Coagulation
Thank You

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Endoscopic Management Of Obesity-Endobariatrics

  • 1. Endoscopic Management Of Obesity (Endobariatrics) Dr.Santosh M Narayankar Department Of Gastroenterology Yashoda Hospital
  • 2. Bridge the gap between medical therapy & surgical management. • It may be used as Primary Therapy Bridging Procedure Revisional Procedure
  • 3.
  • 4. • Preoperative Endoscopy • Post Operative Endoscopic Management Of Surgical Complications • Endoscopic Treatment Of Obesity
  • 5. PRIMARY THERAPY • Intra Gastric Balloons • Tissue Apposition Techniques • Nutrient Diverting Therapies
  • 6. Secondary Therapy • Trans oral outlet reduction • Revision Obesity Surgery Endoscopic • Argon Plasma Coagulation
  • 8. Intra Gastric Balloons • Orbera Balloon –Fluid Filled • Reshape Duo –Fluid Filled • Spatz Ballon-Fluid Filled Adjustable • Obalon Balloon-Gas Filled • Elipse Balloon-Fluid filled • TransPyloric Shuttle FDA Approved in 2015-ReShape and Orbera
  • 9. Orbera Balloon • Most Studied And widely used – Introduced in 1991 • Single,Spherical & made of silicone • Placed Endoscopicaly • Inflated with 400-700ml saline+2 to 10ml Methylene blue • Approved in 2015 by FDA
  • 10.
  • 11.
  • 12. • The ASGE Bariatric Endoscopy Task Force systematically reviewed 82 studies in 2015. • These patients averaged a 25.4% EWL, with a 95% confidence interval (CI) of 21.5% to 29.4%. • Only 3 studies had adequate control groups, with Orbera patients losing an average of 26.9% more weight than control patients , with 95% CI of 15.6% to 38.2%. • A large RCT-results have not yet been published
  • 13.
  • 14. 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
  • 15. • 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 was approved by the FDA for treatment of obesity in 2015. ReShape Duo
  • 16. • The ReShape IGB was evaluated in the REDUCE Trial • The completed study At 24 weeks, Duo subjects had an average %EWL of 25.1% compared with 11.3% in Diet patients(P= . 004) on intention-to-treat analysis. • An average of 66% of weight lost at time of balloon removal was maintained 24 weeks later.
  • 17. • Endoscopically placed, saline-filled single intragastric balloon. • Attached inflation tube -extracted out through the mouth to adjust the balloon volume during therapy to improve tolerance or efficacy. • Not approved by the FDA but is approved in Europe for 12 months of therapy. Spatz -Adjustable Balloon
  • 19. • At present, there are limited safety and efficacy data on the Spatz IGB. • A study of 73 patients in the United Kingdom showed a 45.7% EWL.
  • 20. 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, and is used to inflate the balloon with 250 mL of a nitrogen-mix gas.
  • 22. • Pilot study - 17 patients was undertaken in Europe, with up to 3 balloons given per patient, swallowed individually at 4-week intervals, and removed endoscopically at 12 weeks. • Average EWL at 12 weeks was 36%, with no serious adverse events reported. • Most patients experienced transient abdominal pain and nausea after balloon administration Obalon-Gas Filled Balloon
  • 23.
  • 24. • Enclosed within a capsule with an attached catheter and swallowed under radiographic guidance. • 550ml fluid & remains in stomach for 4 months. • Degrades over 4 months. Elipse-Fluid filled swallowed balloon
  • 26. • An 8-patient pilot study using a prototype demonstrated no adverse events and patients lost an average of 12.4% of excess weight over 6 weeks. • Results of a small multicenter study , yet to be published. Elipse-Fluid filled swallowed balloon
  • 27. TransPyloric Shuttle • Consists of a spherical bulb attached by a flexible cord to a smaller cylindrical bulb • Placed endoscopically and assembled in the stomach. • The large bulb rests in the antrum, with the smaller bulb crossing into the duodenum. • Intermittent obstruction at the pylorus leading to delayed gastric emptying and longer periods of satiety.
  • 28.
  • 29. • One study of 20 participants showed promising results, with mean EWL of 25% at 3 months and 41% at 6 months • Gastric ulcers in 50% of patients with early device removal in 2 patients due to symptomatic gastric ulcers. • The ENDObesity II multicenter study is currently underway, with no results yet published. TransPyloric Shuttle
  • 30.
  • 32. • Gastric volume is reduced by using endoscopically placed sutures to create a gastric sleeve similar to a sleeve gastrectomy. Endoscopic Sleeve Gastroplasty
  • 33. Overstitch endoscopic suturing device (Apollo Endosurgery),an FDA-approved commercial device for the purposes of tissue apposition compatible with a double-channel therapeutic gastroscope
  • 34.
  • 35. • In 2015, midterm results of an open-label trial were reported, with 25 patients (BMI 35.5) enrolled. • All ESGs remained intact by endoscopic evaluation at 3 months, and patients had lost an average of41%of excess body weight at 20 months Endoscopic Sleeve Gastroplasty
  • 36. Primary Obesity Surgery Endoluminal(POSE) • Over tube style incision less operating platform (USGI Medical, San Clemente, California) with 4working channels and accommodates a slim endoscope along with specialized instruments that are FDA-approved for tissue apposition • Transmural tissue anchor plications – • To reduce accommodation of the gastric fundus • Additional plications in the distal gastric body to delay emptying.
  • 38. • Feasibility and safety were demonstrated in a single-center , open-label prospective trial in Spain with 45 patients evaluated, with 49% EWL average at 6 months. • Physiologic changes – • Decreased intake capacity • Initially delayed gastric emptying that returned to baseline by 6 months • Improved insulin sensitivity • Enhanced postprandial decrease in ghrelin. ESSENTIAL, MILEPOST Results have been presented in abstract form, but have not been published
  • 40. Aspiration therapy • New endoscopic approach - Placement of a large per cutaneous silicone gastrostomy tube (A-Tube) that is subsequently connected with a skin port to an Aspire Assist device (Aspire Bariatrics, King of Prussia, Pennsylvania) • The patient uses this system to siphon off a portion of the ingested meal, typically one- third of the volume.
  • 42. • In a small pilot study published in 2013, patients in the aspiration group lost an average of 49% of excess weight, compared with 14.9% in the lifestyle therapy group. Weight loss was maintained at 2-year follow- up. • No serious adverse effects were observed, and no binge eating episodes occurred. • Similar results were obtained in a single-arm prospective trial in Sweden.
  • 43. Duodenal–Jejunal Bypass Liner • Endobarrier (GI Dynamics, Lexington, Massachusetts) is a 65 cm Teflon sleeve that is anchored in the duodenal bulb by a barbed nitinol crown . • The device is placed under endoscopic and fluoroscopic guidance. • Removed endoscopically at 12 months.
  • 45. • Efficacy has been assessed over several studies, with EWL ranging from 30% to47% at 52 weeks. • A recent meta-analysis found that patients had an average of 12.6% EWL with EndoBarrier compared to dietary modification, with an average of 0.9% change in HbA1c that failed to meet statistical significance
  • 46.
  • 47. Gastroduodenal Bypass Liner • Long 120 cm fluoropolymer sleeve has been developed (ValenTx, Hopkins, Minnesota) . • Secured at the GE junction - Endoscopic + Laparoscopic approach. • The device bypasses the stomach, duodenum, and proximal jejunum. • It is also left in place for 12 months and retrieved endoscopically.
  • 49. • A 1-year prospective series with 12 patients enrolled showed an average EWL of 35.9%. • 2 patients had the device removed due to dysphagia and odynophagia, and 4 patients had partially detached devices at 12 months, with inferior weight loss results. • No bowel erosions, ulcerations, or cases of pancreatitis were observed. • A modification device - does not require laparoscopic assistance is being developed.
  • 50. Incisionless Anastomosis System • Endoscopically deliver magnets to adjacent GI lumens, creating entero-enteral bypass anastomoses by magnetic compression. • IAS(GI Windows,Boston, Massachusetts), previously known as self-assembling magnets for endoscopy (SAMSEN), consists of smart magnets that are delivered endoscopically in a linear configuration and form an octagonal shape intra luminally
  • 52. • For bariatric use, this device may induce ileal break with decreased food intake and improved diabetic control. • This system has recently been evaluated in people in a feasibility study in Europe, but the results have not been published yet. Incisionless Anastomosis System
  • 53. Mucosal Resurfacing • The Revita duodenal mucosal resurfacing procedure (Fractyl Laboratories, Cambridge,Massachusetts) • Involves the use of RFA following saline lift to induce mucosal remodeling . • Result in changes in enteroendocrine cells improving diabetic control. • A pilot study has been completed, and a multicenter clinical trial is currently underway in Europe.
  • 56. Transoral Outlet Reduction • Endoscopic Suturing technique • Endoclinch • Apollo Overstictch • Associated - Decreased incidence of • Dumping syndrome • Bile reflux & • Weight regain.
  • 57.
  • 58. Revision Obesity Endoscopic Surgery(ROSE) • Uses the Incisionless Operating Platform (IOP, USGI Medical) to place durable tissue anchors in the gastric lumen to create placations. • In 2009, a multicenter prospective single- arm study of 116 patients ,reported 69% of patients experienced increased satiety; 88% of patients stopped weight regain at 6 months, and 53% of patients achieved an EWL of at least 20%, with a mean 11.3 kg weight loss at 6 months. No significant complications occurred
  • 59. Argon Plasma Coagulation • Used with 65 to 75 W and 2-3 L/m flow can be used on the mucosa in the GJ anastomosis. • Leading to fibrosis of gastric mucosa and subsequent reduction of the GJ stoma.
  • 60. • In a study of 215 patients by Sander and colleagues , APC was used to decrease the diameter of the GJ stoma by almost 50% using an average of 1.36 sessions. • Patients experienced on average 13.8 kg weight loss after the final APC session. • However, 69 patients (32.1%) did not achieve the target stoma diameter. • Main complication - Symptomatic stenosis in 16.3% of patients, necessitating balloon dilation. Argon Plasma Coagulation