Update on Endoluminal Treatment Options for Morbid Obesity

| June 18, 2009

By Amy Cha, MD; Stacy A. Brethauer MD; Aurora Pryor MD; and Bipan Chand, MD

Column Editor: Marc Bessler, MD

This ongoing column investigates current research in the surgical and clinical aspects of obesity treatment and educates bariatric care professionals on the most up-to-date, concrete information on emerging technologies in the field. The second article in 2009’s Emerging Technologies series is authored by Dr. Amy Cha, Dr. Stacy A. Brethauer, and Dr. Bipan Chand, all from the Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio, and Dr. Aurora Pryor from the Duke Center for Weight Loss and Metabolic Surgery, Duke University Medical Center, Durham, North Carolina.Column Editor, Dr. Marc Bessler, a leading authority in the surgical treatment of obesity,  is the Surgical Director, New York-Presbyterian Hospital Center for Obesity Surgery, and Assistant Professor of Surgery, Department of Surgery, Director of Laparoscopic Surgery, Columbia University College of Physicians and Surgeons, New York, New York. 

INTRODUCTION
The field of bariatric surgery has changed tremendously over the last decade. The rapid growth and increased interest in this field can be largely attributed to the application of minimally invasive techniques used within these complex procedures. Lower-risk procedures, such as adjustable gastric banding, and abundant evidence demonstrating the safety and benefit of laparoscopic gastric bypass have increased the level of acceptance for bariatric surgery among patients and referring physicians.[1]

Currently, more than 220,000 bariatric procedures are estimated to be performed annually.[2] This is only 1.6 percent of the 13,750,000 individuals with morbid obesity in the United States[3] who meet NIH criteria for bariatric surgery, however, and there are still many obstacles to patient access and acceptance of these procedures.

There are many reasons for the low penetration of bariatric surgery, many of them beyond the scope of this article. However, it is safe to say that no optimal single procedure has been identified, and the current procedures all have associated risks.[4]  An additional factor that must be considered is that in most cases, patient preference currently determines the type of procedure performed. The emergence of less-invasive technologies that can be performed endoscopically (with presumably much less risk) has great potential for attracting new patients to this field and improving referral patterns.[1]

Another important issue in bariatric surgery is the recidivism and weight regain 3 to 5 years after surgery.[5]

Several devices have been applied to the post-Roux-en-Y gastric bypass (RYGB) problems of stoma dilation, pouch dilation, or fistula repair in an attempt to reduce the risks and complications associated with standard revisional surgery.[5–7]

The purpose of this article is to review the current state of primary and revisional endoluminal therapy for bariatric patients.

ENDOSCOPIC PRIMARY PROCEDURES
Balloon devices for endoluminal restriction. One of the earliest endoluminal devices for the treatment of morbid obesity was the Garren-Edwards bubble. The initial concept of a cylindrical, space-occupying device delivered endoscopically into the gastric lumen was proposed in 1982. It was Food and Drug Administration (FDA)-approved in 1985, and was then removed from the market in 1988 due to poor patient tolerance and efficacy shown in several sham-controlled trials.[8] The mechanism of action of the balloon may be through mechanical satiety, delayed gastric emptying, hormonal modulation, neuronal effects, behavior modification, or placebo. Advantages include ease of placement under deep sedation, ease of modification or reversal, and low morbidity. Disadvantages include modest weight loss and weight regain after removal of the device. An improved version of the Garren-Edwards bubble, the BioEnterics Intragastric Balloon (BIB) system (Allergan, Irvine, California), was released in the mid-1990s. This system includes a silicone balloon filled with 400 to700cc of saline with a maximum placement period of six months (Figures 1A–1B). While the device is not FDA approved for use in the United States, the European experience with the BIB is quite extensive. Genco et al[9] reported the Italian experience in a retrospective study of efficacy and comorbidity reduction. The study included 2,515 patients over four years, with a mean body mass index (BMI) of 44.4kg/m2 and one or more comorbidities in 56.4 percent of patients. After six months of therapy, mean BMI decreased from 44.4 to 35.4kg/m2 with mean excess weight loss (EWL) of 33.9 percent. Medical comorbidities were resolved or improved in 1,242 of 1,394 patients (89.1%). Complications included gastric perforation in five patients (0.19%), 19 gastric obstructions (0.76%), nine balloon ruptures (0.36%), 32 patients with esophagitis (1.27%), five patients with gastric ulcer (0.19%), and 11 balloons removed for patient intolerance (0.44%). Clinical trials are currently underway in the United States. One trial10 randomized 43 patients to BIB or sham for three months, followed by balloon placement and exchange every three months up to one year. Patients were followed for 12 months after BIB removal. Overall, patients in the study had 30 percent EWL and some sustained weight loss at one year after removal, but both sham and BIB groups lost weight with no significant difference between groups. Both groups experienced frequent symptoms with the BIB in place, including nausea, vomiting, and pyrosis more than 50 percent of follow-up days. These complaints were more prevalent in the group that had sham procedure before BIB placement. The authors concluded that the BIB was safe, but the benefit of balloon over sham was not proven. Currently, the BIB is only available as Orbera™ Intragastric Balloon (Allergan, Irvine, California) in Europe.

Within the same category of space-occupying devices for endoluminal restriction is the polymer pill developed by BaroNova Therapeutics, Inc. (Foster City, California). This pill is ingested or delivered endoscopically, expands to take up space in the stomach for one week, and degrades to pass through the gastrointestinal tract. In theory, this can be taken at regular intervals and titrated based upon response.[11] Although not yet clinically tested, this technology holds some promise.

Suturing and stapling devices for endoluminal restriction. An endoscopic vertical banded gastroplasty (VBG) has been reported using a vertical ring gastroplasty created with an endoscopic suturing device, the Endoscopic Sewing Machine (ESM) (C. R. Bard, Inc., Murray Hill, NJ), mounted at the tip of a flexible endoscope. The procedure includes a 3cm plastic ring sutured to the lesser curvature of the stomach 8cm from the GE junction. An 8cm-long tube is created along the lesser curvature by suturing the anterior and posterior walls of the stomach with the ESM. This was performed only as a feasibility study in explanted porcine stomachs[12]; further studies have not been reported.

Other suturing devices have been used in studies for bariatric surgery. The Eagle Claw endoscopic suturing device (Olympus Corporation, Tokyo, Japan) is one of the earliest devices. It was used in a porcine model to create a gastric pouch entirely from within the gastric lumen of an explanted porcine stomach.[13] This pouch was approximately 100cc, which the authors admitted may be too large for weight loss in a morbidly obese patient.[14] Their goal was only to demonstrate feasibility of performing a purely endoluminal procedure to decrease the volume of the stomach. The same group published another set of experiments in four live animals using the Eagle Claw VII. This time they were able to create a much smaller pouch, approximately 30cc in size. The investigation was limited by its design as an acute feasibility study, and short-term success was not evaluated.[15] No further studies in gastric restriction have been performed using this device to date.

The Bard EndoCinch Suturing System (C. R. Bard, Inc., Murray Hill, New Jersey) is an investigational device for endoluminal vertical gastroplasty (EVG). This device uses a suction capsule and suture delivery device attached to a standard endoscope. In 2005, Fogel et al performed a feasibility study in 10 obese patients with a BMI range of 28 to 43kg/m2 who volunteered for the study. The procedure was technically successful in all patients with a procedure time of 60 to 90 minutes, no complications, and a weight loss range of 15 to 49kg at nine months follow up. One repeat procedure was performed for inadequate weight loss in one patient. A second study in 2008 by Fogel et al reported a series of 64 patients with a BMI range of 28 to 60.2kg/m2. The average procedure time for EVG was 45 minutes, with no serious adverse events and no admissions required. Patients reported a noticeable reduction in their hunger and the amount of food they desired to eat. Early weight loss results were comparable to traditional bariatric procedures, with a significant reduction in BMI at 1, 3, and 12 months from baseline (mean [SD] BMI 39.9±5.1kg/m2 vs. 36.5±4.8kg/m2, 33.5±4.5kg/m2, and 30.6±4.7kg/m2). Patients had a significant percentage of EWL (±SD) of 21.1%±62%, 39.6%±11.3%, and 58.1%±19.9% at 1, 3, and 12 months follow-up, respectively. Fifty-nine of the 64 patients (94.1%) were successfully observed with 12 months of follow-up. Fourteen endoscopies were performed at some point between 3 and 12 months for changes in satiety and weight loss stabilization. Of these 14 endoscopies, five patients had intact suture configuration, six patients had loosely intact EVG, and three patients had disrupted EVG. Of these last three cases, another repeat procedure was performed in two; whereas, in the third case, the procedure was left unchanged because the patient was close to the ideal body weight.[16] A new generation of this device (Restore Suturing System™) is currently being evaluated. The TRIM trial (Transoral Gastric Volume Reduction as an Intervention for Weight Management) is a multicenter, prospective, nonrandomized study in the US involving two centers (Brigham and Women’s Hospital, Boston, Massachussetts and Cleveland Clinic, Cleveland, Ohio), with a planned two-year follow-up. Enrollment in this feasibility study has been completed, and six-month weight loss and endoscopic follow-up is to be completed and presented at Digestive Diseases Week 2009.[17]

A primary endoluminal stapling device used in transoral gastroplasty has been reported in two recent human studies out of Belgium and Mexico. The Transoral Gastroplasty (TOGa™) system (Satiety Inc., Palo Alto, California) was used to create a transmural, stapled, restrictive pouch along the lesser curvature of the stomach (Figures 2a–2c), with follow-up at Week 1 and Months 1, 3, and 6. The first study included 21 patients with no serious adverse events. Early results demonstrated a 24.4-percent EWL at six months, with no longer-term data reported. A technical issue with the system was demonstrated in a large number of staple line “gaps” between the first staple and the angle of His, and gaps between the first and second staple lines.[18] The system was redesigned to create overlapping staple lines to reduce the incidence of these gaps, and a second study with 11 patients revealed even more impressive results than the first study. At six months, the average EWL was 46 percent. However, two patients had large outlet sizes at three months, and despite re-treatment, did not have appropriate weight loss. Long-term follow-up is required to determine if staple line dehiscence may occur along with dilation of the outlet.[19] A US multicenter trial is ongoing and should be helpful in validating the short-term results as well as providing long-term results of this system.

The SafeStitch device (SafeStitch Medical Inc., Miami, Florida) is designed as an endoscopic version of laparoscopic suturing, and it may also potentially be used for an endoluminal gastroplasty. This device uses a suction-facilitated endoluminal mucosectomy followed by suture placement to create a gastric pouch while excluding mucosa from the suture line. Clinical trials are slated to begin in 2009.

Several other devices have been developed that may have applications for endoluminal restrictive procedures. Power Medical (Power Medical Interventions, Inc., Langhorne, Pennsylvania) has released a transoral stapling device that can provide endoluminal stapling. The Endoscopic Suturing Device (Wilson-Cook Medical, Winston-Salem, North Carolina) could also be applied to an endoluminal restrictive technique. While these devices have not yet been studied specifically in endoluminal restrictive procedures, they may hold some potential for study in transoral gastric restrictive procedures for obesity.

Endoluminal malabsorptive procedures. Another endoluminal device for weight loss is the duodenal-jejunal bypass sleeve (DJBS), developed as the EndoBarrier™ (GI Dynamics, Lexington, Massachussetts). This device is a flexible, endoscopically placed and removable sleeve (Figure 3A) that is open at both ends and positioned to bypass the duodenum and the first part of the jejunum. The sleeve allows food to pass while preventing contact with the duodenum, biliary, and pancreatic secretions. It is intended to mimic the duodenal and proximal jejunal bypass of a RYGB (Figures 3B–3C). The anchoring system is self-expanding and placed past the duodenal bulb, allowing the barbs to attach to the gastrointestinal tract to decrease risk of migration. To remove the sleeve, the proximal drawstrings are pulled to collapse the anchoring system into a retrieval “hood” that is designed to reduce the risk of injury to the gastrointestinal tract during removal (Figure 3D). In addition to weight loss, the EndoBarrier™ may also have value in the management of type 2 diabetes.[20] The first prospective, open-label, single-center trial by Rodriguez-Grunert et al showed successful placement of 10 sleeves in 12 patients. The sleeve was left in place for 12 weeks, with early removal in two patients due to abdominal pain. Average EWL at 12 weeks was 23.6 percent, with all patients experiencing at least 10-percent EWL. Three of four diabetic patients in the study were successfully managed off medication with normal fasting blood-glucose levels only 24 hours after implantation; the fourth patient demonstrated no improvement. Two mucosal pharyngeal-esophageal tears were reported at extraction as well as some gastrointestinal symptoms within the first two weeks of placement.[21]

A multicenter, randomized, controlled trial was initiated in 2008 with 37 patients, 26 of whom had the EndoBarrier™ DJBS implanted, with 11 diet-controlled patients. Mean procedure time was 33 minutes for insertion and 15 minutes for explantation. The device was left implanted for 12 weeks, with four patients beyond 12 weeks. Starting weight and BMI were comparable between the two groups. At 12 weeks, mean EWL of the sleeve group was 19 percent compared to 6 percent in the control group (p<0.001). Eight type 2 diabetic patients showed a reduction in medications.[22]

Other endoscopic bypass devices include the ValenTx (ValenTx, Inc., Hopkins, Minnesota) and BaroSense (Menlo Park, California). These devices are designed for transoral procedures for gastric restriction with or without combined malabsorptive devices for surgical weight loss. As with many of the other endoluminal therapies, these devices are in varying stages of development and testing.

Neurologic and electromotor devices. Gastric pacing has been shown to effect weight loss in some patients.[23] Endoscopically and laparoscopically placed pacing systems are being developed. Laparoscopically placed systems include the Implantable Gastric Stimulation (IGS) (Medtronic Transneuronix, Inc., Mount Arlington, New Jersey), which has been reported to be more effective than medical weight loss therapy, very safe, and potentially very effective for treating obesity,[24] and the Tantalus System meal-activated device (MetaCure USA Inc., Orangeburg, New York), is a laparoscopically placed device based on new technology called Gastric Contractility Modulation (GCM) that delivers electrical signals synchronized to the intrinsic electrical activity of the stomach.[25] There is currently no published data available on endoscopically placed gastric pacing systems. IntraPace (Mountain View, California) is currently developing one platform for endoscopic placement of gastric pacing for the treatment of obesity.
Laparoscopic truncal vagotomy or vagal blockade has been suggested as an approach to treatment of morbid obesity. It has been demonstrated that patients with peptic ulcer disease temporarily lose weight after gastrectomy and truncal vagotomy. Ghrelin is reduced after this operation, as is the appetite-stimulating effect of ghrelin.[26] Devices for vagal blockade include VBLOC (EnteroMedics, St. Paul, Minnesota) and TEVX (EndoVx, Inc., Napa, California). A large, multicenter study (EMPOWER) is currently being performed to evaluate vagal blockade using the VBLOC for weight loss. While the VBLOC device is placed laparoscopically, endoscopic vagotomy is a logical target for future research.

ENDOSCOPIC REVISION PROCEDURES
Revisional bariatric surgery for weight regain or inadequate weight loss is technically complex and associated with increased postoperative complications.[5–7] Conservative options available for management of poor weight loss after RYGB, including behavior modification, diet, exercise, and medications, are generally no more effective after failed surgery than they are before.[5] Since the precise mechanisms of a successful gastric bypass are not known (relative contribution of restriction, foregut bypass, gut hormone changes), the appropriate target for weight regain patients is poorly understood. Current endoluminal efforts have focused on improving the restrictive component of the operation. The presumption that weight regain is due to pouch or stoma dilation is reasonable, but this has not been proven in any prospective long-term study. Nevertheless, these are accessible targets for endoluminal therapy, and studies evaluating these therapies may improve our understanding of this problem.

Reduction in stoma size as well as pouch size has been attempted through endoscopic injection of sclerosing agents. Sclerotherapy was first reported by Spaulding et al,[27] using sodium morrhuate as the agent. The initial report of 20 patients demonstrated that 75 percent lost weight with an average nine percent weight change six months after sclerotherapy. Average injection volume was 6cc of sodium morrhuate. A more recent publication with more than one year of follow-up of 32 patients demonstrated a reversal of 0.36kg/month weight gain to a 0.39kg/month weight loss. Over half of the patients began to lose weight, and more than 90 percent had weight loss or stabilization. One limitation of their study was that only 32 of 147 patients who underwent sclerotherapy had one year or more follow up.[28] Others have reported similar mixed results; Loewen and Barba[29] reported on 71 patients, 30 percent of whom lost weight and 28 percent gained weight, but 42 percent had no change in their weight. An average of 13cc of sodium morrhuate was injected in their study. Catalano et al[30] reported a much higher rate of weight loss, averaging 22.3kg in 28 patients, with larger quantities of sodium morrhuate injection (average 14.5cc). They injected enough volume to cause the tissue to turn a deep purple. One patient in this study required dilation for a stenosis.

Several devices have been developed to facilitate endoscopic revision of prior bariatric procedures. The Bard EndoCinch Suturing System (C. R. Bard, Inc., Murray Hill, New Jersey) has been applied in the management of post RYGB anastomotic stoma dilatation. A few small reports of successful endoscopic stoma reduction have been published using the EndoCinch device.[31–33] Again, low morbidity compared to revisional surgery is the advantage of the endoscopic approach, but durability remains an important issue. Bard/Davol conducted a multicenter, randomized, sham-controlled trial (Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction, RESTORe trial) to determine if stoma reduction with the EndoCinch device promotes additional weight loss in patients that have had gastric bypass. Enrollment for this study was completed in 2008 and the long-term results are to be reported in 2009.[34]

The G-prox device with Endosurgical Operating System (EOS) (USGI, Inc., San Clemente, California) has been used in the Restorative Obesity Surgery Endoscopic (ROSE) procedure for pouch and stoma reduction in post-RYGB patients. This system involves an over-the-scope platform with four channels, one for the endoscope itself and three for the operating instruments (Figure 4A). With the ability to take a deeper, full-thickness bite for suture placement, the stoma reduction in this procedure may possibly be more durable. However, the platform is cumbersome to use and requires a dilated gastric pouch to accommodate the device. For this reason, the device may be limited to use in patients who have pouch dilation post-RYGB. Herron et al reported feasibility in ex vivo and in vivo porcine models.[35] A single institution series of 21 patients with weight regain post-RYGB averaging 59lb who underwent endoluminal stomal and pouch reduction with the EOS was recently reported at SAGES 2009.[36] Twenty of 21 patients had successful placement of tissue anchors. The abstract reported stomal diameter reduction on average by 53 percent, with pouch reduction averaging 41 pecent. Procedure time averaged 91 minutes with no significant complications. An average of 36 percent of weight regain post-RYGB was lost at theree months follow up in 15 patients. Endoscopy at three months revealed presence of anchors in their original locations, preservation of most of the stoma/pouch reduction, tissue remodeling, and fibrotic tissue folds.  The authors concluded that the EOS may have great potential as a safe and efficacious method for stoma and pouch reduction post-RYGB.

The StomaphyX™ (EndoGastric Solutions, Inc., Redmond, Washington) device is currently available for the treatment of a dilated gastric pouch and stoma following RYGB (Figure 5A). This over-the-scope device uses H-fasteners to create endoluminal plications that decrease pouch size and stoma size (Figure 5B). Ease of use and low morbidity appear to be the advantages of this procedure. The initial US experience will be published in 2009.[37] In 39 patients who underwent endoluminal gastric pouch reduction with the StomaphyX™ device, EWL was 7.4 percent, 10.6 percent, 13.2 percent, 13.2 percent, 17.0 percent, and 19.5 percent at two weeks, one month, two months, three months, six months, and one year, with six patients thus far at one year follow-up. The authors state these results are consistent with initial trials in Belgium with Dr. Himpens’ group, and that the StomaphyX™ procedure may offer an alternative to open or laparoscopic revisional bariatric surgery for weight regain.

Other companies are developing similar endoluminal devices. The NDO Plicator (NDO Surgical, Inc., Mansfield, Massachusetts) is currently off the market, but it also may have bariatric applications. Current evidence for this device is limited to a few case reports.

THE FUTURE OF BARIATRIC SURGERY
While most endoluminal techniques focus on proven surgical concepts of restriction and malabsorption, our understanding of the mechanism of weight loss after bariatric surgery continues to expand. With this expansion comes greater future possibilities for bariatric surgery being safer, more effective, and less costly. Surgical treatment will continue to be important given the poor efficacy of nonsurgical treatments for this complex disease. Adoption of new technology into everyday practice should be based on safety, efficacy, and benefit over the existing procedures.

References
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7.    Jones KB. Revisional bariatric surgery—safe and effective. Obes Surg. 2001;11:183–189.
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17.    Personal communication, TRIM trial
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21.    Rodriguez-Grunert L, Galvao Neto MP, Alamo M. First human experience with endoscopically delivered and retrieved duodenal-jejunal bypass sleeve. Surg Obes Relat Dis. 2008;4(1):55–59.
22.    Schouten R, Rijs C, Bouvy ND, et al. A multi-center efficacy study of the EndoBarrier for pre-surgical weight loss. Presented at: The International Federation for the Surgery of Obesity XIII World Congress; September 2008; Buenos Aires, Argentina.
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24.    Shikora SA, Storch K. Implantable gastric stimulation for the treatment of severe obesity: the American experience. Surg Obes Relat Dis. 2005;1(3):334–342.
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26.    le Roux CW, Neary NM, Halsey TJ, et al. Ghrelin does not stimulate food intake in patients with surgical procedures involving vagotomy. J Clin Endocrinol Metab. 2005;90(8):4521–4524.
27.    Spaulding L. Treatment of dilated gastrojejunostomy with sclerotherapy. Obes Surg. 2003;13(2):254–257.
28.    Spaulding L, Osler T, Patlak J. Long-term results of sclerotherapy for dilated gastrojejunostomy after gastric bypass. Surg Obes Relat Dis. 2007;3(6):623–626.
29.    Loewen M, Barba C. Endoscopic sclerotherapy for dilated gastrojejunostomy of failed gastric bypass. Surg Obes Relat Dis. 2007;4(4):539–542; discussion 542–543.
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31.    Schweitzer M. Endoscopic intraluminal suture plication of the gastric pouch and stoma in postoperative Roux-en-Y gastric bypass patients. J Laparoendosc Adv Surg Tech A. 2004;14(4):223–226.
32.    Starpoli AA. Prospective feasibility study of gastrojejunostomy anastomotic size reduction by endoluminal gastroplication in patients with postgastric bypass recidivism. Gastrointest Endosc. 2005;61:AB240.
33.    Thompson CC, Slattery J, Bundga ME, Lautz DB. Peroral endoscopic reduction of dilated gastrojejunal anastamosis after Roux-en-Y gastric bypass: a possible new option for patients with weight regain. Surg Endosc. 2006;20(11):1744–1748.
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36.    Borao FJ, Gorcey SA, Chaump M. Single site series utilizing the Endosurgical Operating System (EOS) for revision of post Roux-en-Y gastric bypass stomal and pouch dilatation. Presented at: 2009 SAGES Meeting, April 23, 2009, Phoenix, AZ.
37.    Personal communication, StomaphyX trial
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DISCLOSURES
Dr. Brethauer receives research support from Bard/Davol. Dr. Chand’s financial disclosures include research investigator for CR Bard, speaker for Sanofi-Aventis, and speaker for Ethicon Endo-Surgery.

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