Endoscopic Therapies for Obesity

Educational Objectives

The goal of this lecture is to improve the management of obesity. After hearing and assimilating this lecture, the clinician will be better able to:

1. Compare the various endoluminal treatment options used in the management of obesity.

2. Elaborate on the indications and most common adverse events for each of the currently available endoluminal techniques for obesity.

Summary

Current status and efficacy of weight-loss therapies: supervised weight-loss programs — 2% to 3% total body weight loss (TBWL) at 1 yr (similar to unsupervised programs); medications — 5 currently approved by Food and Drug Administration (FDA), with different mechanisms of action and durations of use; result in 3% to 5% TBWL at 1 yr; adverse events (AEs) common (≤20%) and include nausea, diarrhea, and headache; surgery — almost all laparoscopic; 2 most common sleeve gastrectomy and Roux-en-Y gastric bypass; highly effective and results in 20% to 30% TBWL at 1 yr and significant improvement in metabolic profile; disadvantages include permanent alteration to anatomy and weight regain after ≈2 yr

Minimally invasive therapy: benefits of endoluminal therapy — less invasive, scarless, less expensive, outpatient procedure, repeatable, reversible, and multipurpose (cosmesis or treatment of metabolic disease); roles of endoluminal therapies — as primary therapy for those with no previous surgery to induce weight loss and improve metabolic comorbidities; as early intervention or preemptive therapy (before patient becoming morbidly obese); as bridge therapy for superobese patients before undergoing cardiac, orthopedic, or bariatric surgery

Benchmarks of American Society for Gastrointestinal Endoscopy (ASGE): before any endoscopic therapy becomes available on market, must result in excess weight loss (EWL) of ≥25% or TBWL of >5%; in randomized controlled trials, EWL of >15% greater than that of control group desired; must have serious AE rate of <5%

Endoluminal therapies: should always be used as adjunct to lifestyle intervention and/or pharmaceutical therapy; consider for patients who failed to lose weight or maintain weight loss with lifestyle intervention; use as primary therapy in those with body mass index (BMI) >30 and as bridge therapy; any therapy or intervention for obesity must be combined with at least moderate-intensity lifestyle intervention for 12 mo

Intragastric botulinum toxin (BTX) injection: BTX paralyzes smooth muscle, causing delay in emptying of food from stomach, resulting in early satiety and maintenance of satiation after meal; simple and safe; propagatory waves of peristalsis of stomach disappear within minutes; endoscope loaded with 400 IU of BTX placed into stomach and injected in 10 to 20 places; takes 10 min to perform, painless, and patients go home after recovery of ≈20 min; meta-analysis found significant benefit vs placebo, with significant difference in weight loss pre- and postprocedure; EWL 5 to 8 kg; repeatable; however, short duration of action (6 mo) and expensive

Intragastric balloon: approved by FDA in August 2015; balloon filled with 600 to 700 mL of fluid; sits in stomach to occupy space; simple procedure that takes 12 min to perform; balloon removed at 6 mo; balloon sits high up in fundus; mechanically limits food intake and delays emptying of food from stomach; may affect hunger hormones (data controversial); patient able to perform most activities (except diving, as balloon affected by changes in pressure)

Procedure: patient placed in left lateral position; catheter with deflated balloon inserted and run through esophagus and into stomach; fluid injected through catheter to fill balloon; fundus critical area for hunger hormones and eating behavior; balloon left in place, and patient discharged after 1 hr; removal of balloon — performed under sedation; endoscope inserted, needle punctures balloon, and catheter aspirates fluid; balloon removed

Indications and contraindications: indications — adults with BMI ≥30; those with medical comorbidities (eg, diabetes, sleep apnea, heart disease, liver disease) can undergo procedure; patients with previous laparoscopic adjustable banding, as long as band completely deflated or removed; contraindications — not indicated in those with previous sleeve gastrectomy or Roux-en-Y gastric bypass; increases risk for reflux, so not recommended in those with reflux unresponsive to simple medical measures; if evidence of esophagitis, gastric ulcer, or large hiatal hernia present at time of insertion, balloon not placed

Weight loss: expected weight loss 4 to 50 lb at 12 mo; mean EWL at 6 mo after balloon removal 25%, just meeting ASGE threshold for effectiveness; EWL in intragastric balloon group ≈26%, compared to control group; appears effective, with expected TBWL of 12% regardless of BMI before therapy begun

AEs: sometimes necessitate early removal of balloon; short-term AEs — almost always managed medically with aggressive antinausea medication; include nausea, vomiting, regurgitation, abdominal pain (speaker recommends patient not go back to work for 3 days after procedure); regimen of analgesic, antireflux, and antinausea medications recommended after procedure; liquid diet for first week, followed by soft diet for 2 to 3 wk; long-term AEs — pain (33% of cases), nausea (33%), reflux (20%), early removal (7%), ulceration (rare, 2%), migration (1.4%), and gastric perforation (even more rare, 0.1%)

Weight loss and recidivism: most rapid loss seen in first 4 mo, with continued weight loss at 4 to 6 mo; after 6 mo, weight loss tapers off (reason for balloon removal); syndrome of weight recidivism not uncommon after removal, with steady weight gain often seen at 6 mo and 12 mo after removal of balloon; important for patient to be in close contact with physician

Improvement in comorbidities: study of patients with mean BMI of 36 followed for 18 mo found rate of metabolic syndrome decreased from 35% to 12%, diabetes from 33% to 21%, average hemoglobin A1c decreased from 7.5% to 5.5%, and cholesterol decreased; smaller study showed marked improvement in sleep apnea and even reduction in neck circumference; study of 27 infertile women found that with intragastric balloon, reversal of infertility of 55% seen, with all patients carrying pregnancy to full term without obstetric events; multiple studies demonstrate improvement in visceral adiposity, liver fat content, and nonalcoholic steatohepatitis

Endoscopic sleeve gastroplasty: slight variation on sleeve gastrectomy, first reported in 2013; mechanism to reduce gastric volume along same conformation as sleeve gastrectomy by endoscopically involuting greater curvature and fundus of stomach to reduce gastric volume by ≈70%; can perform in patients with previous bariatric surgery; procedure — endoscope passed through esophagus into stomach; ensure that stomach clear; diathermy used to mark areas of stomach; concept is to use suturing system to decrease volume of stomach; nonabsorbable sutures used; bites taken from anterior wall of greater curvature and posterior wall of stomach, then sutures tightened; this shrinks luminal diameter and length of stomach; reinforcing sutures placed to ensure that fundus closed; vascular supply maintained; outcomes — literature very limited; data show reduction of BMI of 5 and EWL of ≈60% (almost as good as sleeve gastrectomy) and improved glucose metabolism; probably works slightly differently than sleeve gastrectomy does (which increases gastric emptying, resulting in food being sensed by ileal mucosa earlier than expected, leading to increase in glucagon-like peptide-1 [associated with metabolic changes that result in decreased appetite and improved glucose metabolism]); data on sleeve gastroplasty based on 4 patients show increased gastric retention (significantly reduced gastric emptying); European study — found TBWL of 20 kg (almost 20%), or EWL of 55%; also found that nutritional follow-up important, with improvement in TBWL and EWL in those adherent to strict nutritional guidelines; saw improvement in eating behaviors (less likely to engage in disorganized meals, speed eating, binge eating, and snacking) and decrease in sedentary behavior; AEs of short duration only; long-term outcomes (durability; risk for reflux) unknown

Transoral gastric outlet reduction: performed with suturing system for patients who regain weight after bariatric surgery; most patients eventually regain 30% of lost weight, and one of reasons is large gastric outlet (gastrojejunal anastomosis in those who have had Roux-en-Y gastric bypass); over time, diameter of anastomosis increases, and pouch can also dilate; procedure takes 15 to 20 min; outlet reduced to 10 mm, and size of pouch reduced with suturing apparatus; study showed that 3 yr after procedure, weight loss of 10 kg achieved and maintained

Suggested Readings

Germanova D et al: Previous bariatric surgery increases postoperative morbidity after sleeve gastrectomy for morbid obesity. Acta Chir Belg, 2013 Jul-Aug;113(4):254-7; Kotzampassi K et al: Looking into the profile of those who succeed in losing weight with an intragastric balloon. J Laparoendosc Adv Surg Tech A, 2014 May;24(5):295-301; Kumbhari V et al: Over-the-scope clips for transoral gastric outlet reduction as salvage therapy for weight regain after Roux-en-Y gastric bypass. Endoscopy, 2015;47 Suppl 1 UCTN:E253-4; Li L et al: Treatment of obesity by endoscopic gastric intramural injection of botulinum toxin A: a randomized clinical trial. Hepatogastroenterology, 2012 Sep;59(118):2003-7; Lopez-Nava G et al: Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscoply, 2015 May;47(5):449-52; Sharaiha RZ et al: Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy, 2015 Feb;47(2):164-6; Su HJ et al: Effect of intragastric balloon on gastric emptying time in humans for weight control. Clin Nucl Med, 2013 Nov;38(11):863-8; Thompson CC et al: Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology, 2013 Jul;145(1):129-137.e3; Yazbek T et al: Laparoscopic sleeve gastrectomy (LSG)-a good bariatric option for failed laparoscopic adjustable gastric banding (LAGB): a review of 90 patients. Obes Surg, 2013 Mar;23(3):300-5; Zheng Y et al: Short-term effects of intragastric balloon in association with conservative therapy on weight loss: a meta-analysis. J Transl Med, 2015 Jul 29;13:246.

Readings

Disclosures

For this lecture, members of the faculty and planning committee reported nothing to disclose. In his lecture, Dr. Kumbhari presents information that is related to the off-label or investigational use of a therapy, product, or device.

Acknowledgements

Dr. Kumbhari was recorded at the 61st Annual Philip A. Tumulty Topics in Clinical Medicine, held May 2-6, 2016, in Baltimore, MD, and presented by the Johns Hopkins University School of Medicine, Office of Continuing Medical Education. For information about upcoming CME activities from Johns Hopkins University School of Medicine, visit their website at www.hopkinscme.edu. The Audio Digest Foundation thanks the speakers and the sponsor for their cooperation in the production of this lecture.

CME/CE INFO

Accreditation:

The Audio- Digest Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Audio- Digest Foundation designates this enduring material for a maximum of 0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Audio Digest Foundation is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's (ANCC's) Commission on Accreditation. Audio Digest Foundation designates this activity for 0 CE contact hours.

Lecture ID:

IM632901

Expiration:

This CME course qualifies for AMA PRA Category 1 Credits™ for 3 years from the date of publication.

Instructions:

To earn CME/CE credit for this course, you must complete all the following components in the order recommended: (1) Review introductory course content, including Educational Objectives and Faculty/Planner Disclosures; (2) Listen to the audio program and review accompanying learning materials; (3) Complete posttest (only after completing Step 2) and earn a passing score of at least 80%. Taking the course Pretest and completing the Evaluation Survey are strongly recommended (but not mandatory) components of completing this CME/CE course.

Estimated time to complete this CME/CE course:

Approximately 2x the length of the recorded lecture to account for time spent studying accompanying learning materials and completing tests.