Full-thickness Endoscopic Suturing Research Articles

Pilot study of an endoluminal-suturing device as a treatment for patients with gastroesophageal reflux disease.

Background and study aims Endoscopic therapy is a promising option for patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess safety and feasibility of the Endomina suturing platform as a treatment for GERD. Patients and methods This was a two-center study of patients with chronic GERD symptoms that responded at least partially to proton pump inhibitors (PPIs). Primary endpoints were to assess the safety of the procedure and persistence of the sutures. Secondary endpoints were to assess esophageal pH-impedance and manometry parameters changes at 6 months, as well as GERD symptoms and PPI use up to 12 months of follow-up. Results Fourteen patients were treated (13 males, mean of 43±12 years), with a mean number of three plications per patient. Thirteen, 10, and nine patients were analyzed at 3, 6, and 12 months of follow-up, respectively. One device-related adverse event occurred (loss of needle tip requiring endoscopic retrieval 1 week later). A mean of two plications persisted at 3 and 12 months. A decrease in median acid exposure time and reflux episodes was observed after the procedure. Mean Reflux Symptom Index and GERD-Health-Related Quality of Life scores decreased during follow-up visits and 90% of the patients discontinued PPI use at 1 year. Conclusions Endoscopic full-thickness suturing of the esophagogastric junction with the Endomina suturing platform is feasible, allowing persistence of two-thirds of the plications, with promising results for decreasing reflux and improving GERD symptoms.

A Comprehensive Review on Bariatric Endoscopy: Where We Are Now and Where We Are Going

Background: Obesity is a chronic disease that impairs quality of life and leads to several comorbidities. When conservative therapies fail, bariatric surgical options such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are the most effective therapies to induce persistent weight loss. Over the last two decades, bariatric endoscopy has become a valid alternative to surgery in specific settings. Primary bariatric endoscopic therapies: Restrictive gastric procedures, such as intragastric balloons (IGBs) and endoscopic gastroplasty, have been shown to be effective in inducing weight loss compared to diet modifications alone. Endoscopic gastroplasty is usually superior to IGBs in maintaining weight loss in the long-term period, whereas IGBs have an established role as a bridge-to-surgery approach in severely obese patients. IGBs in a minority of patients could be poorly tolerated and require early removal. More recently, novel endoscopic systems have been developed with the combined purpose of inducing weight loss and improving metabolic conditions. Duodenal mucosal resurfacing demonstrated efficacy in this field in its early trials: significant reduction from baseline of HbA1c values and a modest reduction of body weight were observed. Other endoscopic malabsorptive have been developed but need more evidence. For example, a pivotal trial on duodenojejunal bypasses was stopped due to the high rate of severe adverse events (hepatic abscesses). Optimization of these more recent malabsorptive endoscopic procedures could expand the plethora of bariatric patients that could be treated with the intention of improving their metabolic conditions. Revisional bariatric therapies: Weight regain may occur in up to one third of patients after bariatric surgery. Different endoscopic procedures are currently performed after both RYGB and SG in order to modulate post-surgical anatomy. The application of argon plasma coagulation associated with endoscopic full-thickness suturing systems (APC-TORe) and Re-EndoSleeve have shown to be the most effective endoscopic treatments after RYGB and SG, respectively. Both procedures are usually well tolerated and have a very low risk of stricture. However, APC-TORe may sometimes require more than one session to obtain adequate final results. The aim of this review is to explore all the currently available primary and revisional endoscopic bariatric therapies focusing on their efficacy and safety and their potential application in clinical practice.

A novel approach for weight regain after Roux-en-Y gastric bypass: Staged transoral outlet reduction (TORe) followed by surgical type 1 distalization.

Video 1Transoral outlet reduction.Video2. Laparoscopic type 1 distalization of the Roux limb.

The efficacy and long-term outcomes of endoscopic full-thickness suturing for chronic gastrointestinal fistulas with an Overstitch device: is it a durable closure?

Endoscopic closure of chronic gastrointestinal fistulas (CGFs) is challenging due to their epithelialized surfaces. The aim of this study was to assess the efficacy and long-term closure rate of endosuturing for CGFs with an Apollo Overstitch device. Consecutive CGF patients undergoing endosuturing for fistula closure from April 2018 to January 2020 at the First Affiliated Hospital of Nanjing Medical University were enrolled for retrospective review. Demographics, fistula characteristics, details of the suturing procedures and outcomes were collected for analysis. Twenty patients (mean age 59.8 ± 9.1years; 85% males) with a total of 23 CGFs underwent sutured fistula closure. Esophagotracheal fistulas were the most common CGFs (12/23, 52.2%), and prior cancer surgery was the most common fistulization etiology (14/20, 70%). Twelve patients (12/20, 60%) had undergone failed endoscopic attempts at fistula closure before suturing. Additional endoscopic therapies used during suturing were 100% argon plasma coagulation, 50% clip fixation, and 10% stent placement. Although all patients undergoing suturing achieved immediate technical success of fistula closure, sustained fistula closure was observed in only 5 patients (5/20, 25.0%) on surveillance endoscopy 3months after suturing with a mean follow-up of 19.5months. Esophagotracheal fistula patients were predisposed to shorter dehiscence-free survival than those with other fistulas (HR 3.378; 95% CI 1.127-10.13). Endosuturing is safe and should be considered for use as the first-line or salvage therapy for CGF closure, primarily for patients with fistulas not involving the trachea. However, the long-term healing of CGFs by suturing is challenging, and CGF patients might not benefit from repeated suturing.

S1035 Social Determinants of Weight Loss Following Transoral Outlet Reduction (TORe) at a Safety-Net Hospital

Introduction: Roux-En-Y gastric bypass (RYGB) is a bariatric surgery for weight loss (WL) among obese patients. Weight regain (WR) is a common complication of RYGB. One anatomic etiology of WR after RYGB is dilation of the gastrojejunal (GJ) anastomosis outlet. Transoral Outlet Reduction (TORe) is an endoscopic therapy using a full thickness endoscopic suturing device to narrow the GJ outlet. Given the novelty of bariatric endoscopy, most insurance does not cover the cost. There is little data on outcomes of bariatric endoscopy in underserved populations. Our study aimed to assess the impact of socioeconomic and demographic factors on WL after TORe at our safety net hospital. Methods: We performed a retrospective chart review of patients who underwent TORe for post-RYGB WR from November 2016 to September 2020. Data collected included age, gender, ethnicity, highest education level, income, marital status, insurance status, number of children and procedural outcomes (weight, metabolic parameters). We performed a multivariable linear regression analysis using R© software to assess the relationship of social factors to TORe outcomes. Results: We analyzed 45 TORe procedures. The cohort was predominantly female (98%) with a mean age of 42 years. Of the 45 TORes, 7 were performed in Black patients, 31 Hispanic, 3 Asian, 1 White and 3 in patients of unknown ethnic background. Thirty-one (69%) TORes were in patients with annual household incomes of less $50,000 and 22 (49%) with only a high school level education. Thirty-five (67%) procedures were performed in patients who were unmarried and 32 (71%) procedures were performed in patients with insurance. The mean diameter of the pre-TORe GJ outlet was 27.5 mm. Mean weight lost post-TORe was 12.5 lbs which corresponded to a 5.7% WL and 3.5% reduction in BMI. Compared to an annual income of less than $10,000, a patient with an annual income of $10,000-$50,000 would be 3.87 times as likely to have post-TORe per lb WL (p=0.15), and 4.50 times as likely to with an annual income of $50,000-$100,000 (p=0.26). We also found that having insurance made it 2.75 times as likely to promote post-TORe per lb WL compared to being uninsured (p=0.313). Conclusion: Social determinants of health are known to impact obesity and post-operative outcomes in bariatric surgery patients. We found in our analysis of an underserved bariatric population at our public hospital that a higher income and having insurance was positively associated with better post-TORe WL.Table 1.: Multivariable linear regression analysis of social determinants of post-TORe weight loss; Income 1: less than $10,000; Income 2: $10,000-$50,000; Income 3: $50,000-%100,000.

The First Endoscopic Sleeve Gastroplasty and Transoral Outlet Reduction in Thailand: Case Report and Literature Review

Obesity is becoming a universal healthcare problem. The role of endoscopic bariatric and metabolic therapies is emerging in the management of obesity and its related conditions. The endoscopic treatment can be used as a primary weight loss procedure and a revision procedure after bariatric surgery. While the prevalence of obesity has been rising over the past two decades in Thailand, the treatment options have been limited to diet and exercise, pharmacological treatment, and bariatric surgery until recently. In 2020, an endoscopic full-thickness suturing device was introduced to Thailand, leading to successful endoscopic bariatric therapy using a suturing device in Thai patients. This article intends to report the first successful endoscopic sleeve gastroplasty and transoral outlet reduction in Thailand with a mini-review focusing on these two procedures' outcomes.

The Efficacy and Safety of Endoscopic Sleeve Gastroplasty as an Alternative to Laparoscopic Sleeve Gastrectomy.

Endoscopic sleeve gastroplasty (ESG) is a therapeutic endoscopic technique for reducing the size of the gastric reservoir in obese patients, using a full-thickness endoscopic suturing device. The effectiveness of ESG in weight loss is significantly greater than that of high-intensity diet and lifestyle therapy and lower than that of laparoscopic sleeve gastrectomy (LSG). The efficacy at 12 months after ESG in terms of percentage of total body weight loss and excess body weight loss was approximately 16% and 60%, respectively. The well-known predictive factors for increased weight loss by ESG are good compliance with regular monitoring and post-procedure care involving a multidisciplinary team approach. Although the underlying mechanism of weight loss induced by ESG is debatable, delayed gastric emptying and early satiation are some of the proposed mechanisms. The pooled rate of adverse events after ESG reported in several meta-analysis studies ranged from 1.5% to 2.3% and the incidence of new-onset gastroesophageal reflux disease after ESG was negligible, indicating that ESG has a superior safety profile to LSG. Moreover, ESG reduced the risk of obesity-related metabolic comorbidities, evidenced by the reduction in HbA1c level, systolic blood pressure, triglyceride level, and risk of hepatic steatosis and fibrosis; it even improved the quality of life. ESG could be considered safe and qualify as an alternative treatment to LSG.

Symptom resolution of bile reflux gastritis after transoral gastric outlet reduction in a patient with Billroth II anastomosis.

Endoscopic transoral outlet reduction (TORe) utilizing a full thickness endoscopic suturing device is a minimally invasive therapeutic option in bariatric surgery patients who have experienced weight gain, but also can be used in patients who underwent Billroth II (B-II) procedure with biliary reflux symptoms.

S1869 Transoral Gastric Outlet Reduction in a Patient With Billroth II Anastomosis for the Treatment of Severe Bile Acid Reflux

INTRODUCTION: Endoscopic transoral outlet reduction (TORe) utilizing a full thickness endoscopic suturing device is a minimally invasive therapeutic option in bariatric surgery patients who have experienced weight gain. This procedure can be therapeutic not only for weight gain after Roux-en-Y Gastric Bypass (RYGB), but also can be used in patients who underwent Billroth II procedure with biliary reflux symptoms. CASE DESCRIPTION/METHODS: A 68-year-old female patient with a past medical history of hypertension, dyslipidemia and prior Billroth II procedure for management of peptic ulcer disease presented with severe epigastric pain and bloating after meals refractory to PPI use. She underwent an EGD and was diagnosed with severe biliary gastritis. Transoral endoscopic gastric outlet reduction was recommended for this patient. A diagnostic flexible endoscope was advanced to the site of gastroduodenal anastomosis. Then, the gastric mucosa on the side of the anastomosis was aggressively ablated using argon plasma coagulation (APC). An endoscopic scissor was then used for trimming the previous suture remnants. A double channel scope was then inserted with the OverStitch device. A 2-0 Prolene suture was placed at the 3 O'clock position using full thickness running suture technique. A total of 4 bites were used. The suture was subsequently tightened with the creation of pseudo-pyloric opening. A total of one cinch was deployed to keep the suturing material permanently reinforced. No complications occurred throughout the procedure. Post-procedure follow up was normal with complete resolution of the patient's symptoms. DISCUSSION: Transoral endoscopic gastric outlet reduction is an emerging procedure used to manage weight gain after RYGB. The two-fold running suture technique is a novel method that can be used very effectively in this procedure. We have demonstrated that transoral outlet gastric reduction is not only effective for patients who have gained weight after RYGB, but also therapeutic in the improvement of biliary reflux symptoms after Billroth II procedure.Figure 1.: Argon plasma coagulation of the anastomotic margin.Figure 2.: Endoscopic suturing using the Apollo OverStitch device.Figure 3.: Creation of pseudo-pyloric opening.

Sa1938 SEVEN YEAR OUTCOMES OF TRANSORAL OUTLET REDUCTION (TORE) FOR THE TREATMENT OF WEIGHT REGAIN FOLLOWING ROUX-EN-Y GASTRIC BYPASS

Weight regain following Roux-en-Y gastric bypass (RYGB) is a growing problem. Transoral Outlet Reduction (TORe) is a commonly performed procedure to address this condition, and the aim of this study is to assess its long-term efficacy. Study Design: A retrospective review of prospectively collected data on RYGB patients who underwent TORe for weight regain. Technique: TORe was performed using a full-thickness endoscopic suturing device. The GJA was ablated using argon plasma coagulation (APC). Stitches were placed around the GJA to reduce its size. Primary Outcome: Percent total weight loss (%TWL) at 7 years following TORe. Secondary Outcomes: Procedure details, safety profile classified using the ASGE lexicon, number needed to treat (NNT) to stop weight regain and predictors of %TWL at 7 years following TORe. A total of 443 RYGB patients underwent TORe and were included in the study. Baseline age, weight and BMI were 49±11 years, 116.9±28.4 kg and 41.8±10.5 kg/m2. On average, the patients were 7±3 years post-RYGB and had regained 43.9±26.3% of maximal weight lost. Pre-TORe GJA size was 25.0±6.4 mm, which decreased to 7.2±2.6 mm after TORe. Primary Outcomes: Patients lost 9.5±9.5 kg, 8.6±11.7, 10.5±17.5 kg and 10.1±16.0 kg at 1, 3, 5 and 7 years, respectively (p<0.01 for all). This corresponded to 7.5±6.6%, 6.9±8.9%, 7.5±14.4% and 8.4±12.8% TWL at 1, 3, 5 and 7 years with follow-up rates of 86%, 94%, 86% and 72% of patients eligible for follow-up at these time points, respectively (Figure 1). Secondary Outcomes: 80.3%, 16.1% and 3.6% of the cases were performed using single pursestring, interrupted, and double pursestring suture patterns, respectively, with an average of 10±4 stitches (bites) per GJA. Pouch reinforcement suturing was performed in 62%, with an average of 3±2 stitches per pouch. There were no severe adverse events. At 7 years, 32% of the patients had an additional weight loss therapy including pharmacotherapy (18%), repeat TORe (10%), and surgical revision (4%). The NNT to stop weight regain at 7 years was 1.3. Amount of weight loss at 1 year (β=0.67, p=0.03) was a predictor of %TWL at 7 years after controlling for age, sex, weight regain and the use of adjunctive therapy. TORe appears safe, effective and durable at treating weight regain following RYGB, with a NNT of 1.3. The amount of weight loss at 1 year predicts 7-year efficacy and may help direct use of adjunctive therapy.

Argon plasma coagulation alone versus argon plasma coagulation plus full-thickness endoscopic suturing to treat weight regain after Roux-en-Y gastric bypass: a prospective randomized trial (with videos)

A significant number of patients regain weight after Roux-en-Y gastric bypass. Ablation with argon plasma coagulation (APC) plus endoscopic full-thickness suturing (FTS-APC) and ablation alone have been reported for treating weight regain when associated with gastrojejunostomy (GJ) dilation. However, comparative controlled data are still lacking. This was a pilot single-center open-label randomized trial comparing the effectiveness and safety of APC alone versus FTS-APC for transoral outlet reduction. Patients with at least 20% weight regain from the nadir, and GJ≥15mm were considered eligible. The primary outcome was percentage total weight loss (%TWL) at 12 months. Secondary outcomes were the incidence of adverse events, amelioration of metabolic laboratory parameters, and improvement in quality of life and eating behavior. Forty patients meeting the eligibility criteria were enrolled from October 2017 to July 2018. Technical and clinical success rates were similar between the groups. At 12 months, the mean %TWL was 8.3% ± 5.5% in the APC alone group versus 7.5% ± 7.7% in the FTS-APC group (P= .71). The pre-revisional % solid gastric retention at 1 hour positively correlated with the probability of achieving≥10% TWL at 12 months. Both groups experienced significant reductions in low-density lipoprotein and triglyceride levels at 12 months, and improvement in eating behavior and quality of life at 3 months. There were 2 cases of stenoses (1 from each group), which were successfully treated with endoscopic balloon dilation. APC alone is similar to FTS-APC in terms of technical and clinical outcomes within 1 year of follow-up. (Clinical trial registration number: NCT03094936.).

Endoscopic management of dumping syndrome after Roux-en-Y gastric bypass: a large international series and proposed management strategy

Roux-en-Y gastric bypass (RYGB) is refractory to lifestyle and pharmacotherapy measures, requiring reversal of the patient's bariatric surgery. Reversal can lead to weight regain and recrudescence of their comorbidities. Our aim was to report a multicenter experience on the endoscopic management of refractory dumping syndrome with endoscopic transoral outlet reduction (TORe). A multicenter international series of consecutive patients who underwent TORe with a full-thickness endoscopic suturing device was analyzed for technical success, improvement in Sigstad scores, and weight trajectories after the procedure. Failure was defined as needing an enteral feeding tube, surgical reversal, or repeat TORe. One hundred fifteen patients across 2 large academic centers in Germany and the United States underwent TORe for dumping syndrome. Patient age was mean 8.9 ± 1.1 years from their initial RYGB with an average percent total body weight loss of 31% ± 10.6% at the time of endoscopy. Three months postprocedure, the Sigstad score improved from a mean of 17 ± 6.1 to 2.6 ± 1.9 (paired t test P= .0001) with only 2% of patients (n= 2) experiencing weight gain. Mean weight loss and percentage of total body weight loss 3 months post-TORe were 9.47 ± 3.6 kg and 9.47% ± 2.5%, respectively. Six patients (5%) failed initial endoscopic therapy, with 50% (n= 3) successfully treated with a repeat TORe. Three patients underwent surgical reversal, indicating an overall 97% endoscopic success rate. TORe as an adjunct to lifestyle and pharmacologic therapy for refractory dumping syndrome is safe and effective at improving dumping syndrome and reducing rates of surgical revision.

Five-year results of endoscopic gastrojejunostomy revision (transoral outlet reduction) for weight gain after gastric bypass.

The study aim is to determine if patients who have undergone endoscopic gastrojejunostomy revision (EGJR) maintain weight loss up to 5years postoperatively. This is a retrospective review of patients who underwent EGJR with a full-thickness endoscopic suturing device between April 2009 and June 2018. Percent of excess body weight loss (%EBWL) was calculated using the weight on day of EGJR consult as baseline. The paired t test and McNemar's test were used to compare weight and comorbidities between preoperative and postoperative time points. A total of 70 patients regained a mean of 42.8 ± 18.7% of the weight lost after gastric bypass. On day of EGJR consult, average was 116.1 ± 25.2kg and BMI of 42.3 ± 8.5. Weight loss and %EBWL at follow-up was as follows: 10.7 ± 11.6kg and 18.5 ± 18.2% at 6months, 8.5 ± 11.5kg and 14.9 ± 20.6% at 1year, 6.9 ± 10.7kg and 12.2 ± 19.8% at 2years, 5.3 ± 9.1kg and 8.7 ± 14.9% at 3years, 3.1 ± 12.0kg and 3.2 ± 21.6% at 4years, and 3.9 ± 13.1kg and 7.0 ± 23.8% at 5years. The percentage of patients with obstructive sleep apnea, hypertension, hyperlipidemia, and diabetes did not change over time. Patients who received a pursestring revision or had a greater percent reduction in stoma diameter had more significant %EBWL. Weight loss after EGJR is sustained up to 5years after revision with little effect on medical comorbidities. Patients with a greater reduction in stoma diameter experienced superior weight loss.

Endoscopic augmentation of gastroesophageal junction using a full-thickness endoscopic suturing device.

Background and study aims This preliminary study was conducted to determine the feasibility and safety of endoscopic augmentation of the gastroesophageal junction (GEJ) using the Apollo OverStitch endoscopic suturing system in patients with gastroesophageal reflux disease (GERD) symptoms. Patients and methods Endoscopic augmentation of GEJ was performed on 10 consecutive patients and the data were analyzed retrospectively. Using a double-channel gastroscope affixed to the endoscopic suturing platform, interrupted sutures were placed on the gastric side of the GEJ in 2 layers in order to create a narrowed and elongated GEJ. Results Technical success was achieved in all patients, including those with a history of previous antireflux procedures (n = 7) and those with a hiatal hernia (n = 6). The median follow-up duration was 5 mo (range: 2 – 12). The median pre-procedure GERD-Health Related Quality of Life Questionnaire improved from 20 (range: 11 – 45) to a post-procedure score of 6 (range: 3 – 25) ( P = 0.001). The median duration of GERD symptom improvement after the procedure was 1 mo (range: 0.5 – 4). Adverse events were limited to 1 patient who developed nausea and vomiting, which was self-limited. Conclusions The use of a novel endoscopic suturing technique for the treatment of GERD is feasible and safe. The procedure resulted in short-term GERD symptom improvement. Further prospective studies using refined techniques are currently underway to improve durability and to prove efficacy.

Tu1092 SAFETY AND EFFICACY OF ENDOSCOPICALLY SECURED FULLY COVERED SELF EXPANDABLE METALLIC STENTS (FCSEMS) IN THE STOMACH

Symptomatic gastric strictures or stenosis in the context of post-surgical anatomy can be recalcitrant to conventional endoscopic therapies, with patients often requiring surgical revision. Fully covered self expandable metallic stents (FCSEMS) in conjunction with our ability to secure the stent with endoscopic sutures has opened the door to treat non-malignant gastric stenosis. To assess the technical feasibility, efficacy, tolerability and safety of long term dwell of endoscopically secured FCSEMS in the stomach. A retrospective review of a prospectively collected database (September-2016 to November-2017) was performed to identify consecutive patients who underwent EGD and through the scope FCSEMS insertion in the stomach.The stent was endoscopically secured with four 2-0 Prolene sutures with the use of a full thickness endoscopic suturing system. The suture pattern was as follows: bite using the tissue helix through the gastric wall, bite through the stent, then bite using the tissue helix through the gastric wall. Technical success was defined as successful stent deployment and securing of the stent with sutures. Short term success was defined as resolution symptoms at 1 month. Long term clinical success was defined as resolution or improvement of symptoms 3 months post stent removal. Ten patients (3M, median age of 53(30-81)) were included. The indications for stent insertion and prior failed therapies can be seen in Table 1. All stent insertions and suturing were technically successful (100%). The stents were well tolerated with only 24 hours of mild post-procedural discomfort likely related to the suturing process. Median stent dwell was 243 (126-342) days for those who had their stents removed (6 patients) (Figure 1). Four patients have not yet had their stents removed at the time of data collection. Two patients had stents with tissue ingrowth into the covered stent and one patient had hemi-circumferential ulceration at margins. One patient was treated by the insertion of consecutive long term sutured stents with dwell times of 246, 181 and 34 days consecutively. Three patients experienced stent migration. Patient 1 passed the stent at day 342 per rectum without complication. Patients 2 and 10 did not return for their scheduled follow-up and required surgical resection for stent removal at day 276 and 241, respectively. There was no unanticipated admission due to stent intolerance. All patients had short term success (100%). Long term clinical success was seen in 50% (3/6) of the patients. A FCSEMS, if secured in the stomach, may be safe, tolerable, and effective for long dwell time. Despite aggressively securing with sutures, stents appear to migrate after approximately 6 months and one should remove or exchange the stent at around this time.Table 1–Clinical characteristics of all patients with secured FCSEMS in the stomach.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique

Endoscopic sutured gastroplasty (ESG) has evolved over time. With the advent of full-thickness endoscopic suturing, an efficient technique for ESG was developed and refined. This prospective first-in-man trial started in April 2012 and represents the first use of full-thickness endoscopic suturing for primary obesity therapy. The trial focused on procedure development, reproducibility, safety, and short-term efficacy. The trial was performed at centers in five countries, in three phases. Phase I was evaluation of safety and technical feasibility of various procedure techniques; stitch patterns and sequences were assessed for efficiency, safety, and feasibility. Phase II entailed continued procedure refinement to establish a standardized technique. Phase III entailed evaluation of technical feasibility and weight loss outcomes in 77 patients; the procedure was performed using the standardized technique, and there was no procedure development. Data were prospectively collected into a registry. In Phase I, the procedure was created and modified to improve time efficiency. Safety and technical feasibility were established, and short-term weight loss was demonstrated. In Phase II, a number of stitch patterns were attempted, and the stitch pattern was modified and finalized. 22 patients were included, and 1-year total weight loss was 17.3 ± 2.6%. In Phase III, conformity with the final technique was high. 77 patients were included, with a mean BMI of 36.1 ± 0.6kg/m2. Mean weight loss was 16.0 ± 0.8% at 6months and 17.4 ± 1.2% at 12months (n = 44). Postprocedural nausea, vomiting, and epigastric pain were frequently reported; there were no reported significant adverse events post-procedure or during the follow-up period. Following a methodical procedure development phase, ESG demonstrated safety and short-term efficacy in this trial. The procedure also achieved meaningful weight loss during the follow-up period.

Transoral Outlet Reduction for Therapy of Weight Regain After Gastric Bypass

Introduction: Enlargement of gastrojejunal anastomosis aperture is associated with weight regain in patients with Roux-en-Y gastric bypass (RYGB). Endoscopic transoral outlet reduction (TORe) has proven safe and effective for treatment of weight regain. The objective of this study was to evaluate the safety and the efficacy in weight loss of endoscopic outlet reduction in single Italian center.FigureMethods: The series included consecutive post-RYGB patients with weight regain and enlarged gastrojejunal anastomosis aperture (>15 mm). Endoscopic reduction was performed with Overstitch (Apollo Endosurgery) which is a full-thickness endoscopic suturing device. All the procedures were done at the Digestive Endoscopy Unit of the Catholic University of Rome. The procedure was done with the Overstitch and Olympus double channel operative endoscope. An Overtube was placed before the procedure in all patients. Before suturing the outlet rims were cauterized with pulsed pulsed Argon Plasma on 40 Watts. Results: Thirty-five patients who had weight regained after RYGB (BMI > 30) underwent TORe from January 2015 to February 2017. Baseline mean BMI was 37.9 (range 31-50) and weight was 106.8 kg (range 77-132). Mean procedure time was 34 minutes (range 15-60) and a mean number of 2.3 stitches per patient were placed (range 2-4) on the level of the gastric outlet. After suturing the patency of the new redone outlet was tested with standard gastroscope. There were three (9%) complications of which two were mild (1 intraoperative bleeding that arrested spontaneously and 1 patient with fever due to small retrogastric collection treated with antibiotics), while one patient (5.2%) had gastric perforation that required urgent surgery. Mean hospital stay was 2.4 days (range 1-10). Telephonic follow-up was done at 1, 3 and 6 months. Thirty-two patients completed at least 1 month follow up. Mean weight loss at 1 month follow-up was 9.3 kg, at 3 months was 12.7 kg while at 6 months was 15 kg. Only one patient regained weight compared to baseline during the 6 months follow up. Conclusion: In our experience TORe was a safe and effective procedure in patients with weight regain after RYGB. Longer follow-up and larger clinical trials are needed to establish the durability of these results and to better understand the role of TORe after RYGB and the methods for proper selection of the patients.

Endoscopic sleeve gastroplasty and its application to China.

Obesity is a burgeoning problem in China with potential for significant adverse economic and health consequences if not addressed. Unfortunately, the body mass index (BMI) targets used in the West are not applicable to China as Asians have visceral adiposity and thus develop complications of obesity at a lower BMI. Recent studies suggest using lower BMI targets for defining overweight and obesity and to qualify patients for bariatric surgery. Diet, exercise and pharmacology have been the foundation for treatment in those not meeting criteria for bariatric surgery, despite modest weight loss that is poorly sustained over time. The large majority in China are averse to bariatric surgery and thus endoscopic bariatric therapy is emerging as an illustrious remedy to fill this gap. Of the current procedures available endoscopic sleeve gastroplasty has shown the most promise due to the significant and sustained weight loss it produces coupled with the ease of execution and lower cost. The procedure is performed under general anesthesia using a full-thickness endoscopic suturing device and patients are discharged the same day. The mean procedure time in experienced hands is 60 minutes. Due to the repetitive nature of the procedure, the learning curve is steep. Data thus far demonstrate total body weight loss to be 16-20% at 12 months. The safety profile is excellent with a low morbidity rate seen in the 3 000 procedures performed worldwide. Therefore, widespread dissemination in China is expected with the potential to help millions of obese patients.

Transoral outlet reduction with full thickness endoscopic suturing for weight regain after gastric bypass: a large multicenter international experience and meta-analysis.

Many patients who undergo bariatric surgery will experience weight regain and effective strategies are needed to help these patients. A dilated gastrojejunal anastomosis (GJA) has been associated with weight recidivism after Roux-en-Y gastric bypass surgery (RYGB). Endoscopic transoral outlet reduction (TORe) with a full thickness endoscopic suturing device (Overstitch, Apollo Endosurgery, Austin, TX) is a minimally invasive therapeutic option. The primary aim of this project was to examine the safety and long-term efficacy data from three bariatric surgery centers and to conduct a systematic review and meta-analysis of the existing literature. Patients who underwent TORe with the Overstitch device from Jan 2013 to Nov 2016 at 3 participating bariatric surgery centers were included in the multicenter analysis. For the systematic review and meta-analysis, a comprehensive search of multiple English databases was conducted. Random effects model was used. 130 consecutive patients across three centers underwent TORe with an endolumenal suturing device. These patients (mean age 47; mean BMI 36.8) had experienced 24.6% weight regain from nadir weight after RYGB. Average weight lost at 6, 12, and 18months after TORe was 9.31±6.7kg (N=84), 7.75±8.4 kg (N=70), 8±8.8kg (N=46) (p<0.01 for all three time points), respectively. The meta-analysis included 330 patients. The pooled weight lost at 12months was 8.4kg (95% CI 6.5-10.3) with no significant heterogeneity across included studies (p=0.07). Overall, 14% of patients experienced nausea, 18% had pain and 8% required a repeat EGD. No serious adverse events reported. When implemented as part of a multidisciplinary intervention, TORe using endolumenal suturing is safe, reproducible, and effective approach to manage weight recidivism after RYGB and should be utilized early in the management algorithm of these patients.

Su2039 - Transoral Oulet Reduction with Full Thickness Endoscopic Suturing for Weight Regain after Gastric Bypass: A Large Multicenter International Experience and Meta-Analysis

Su2039 - Transoral Oulet Reduction with Full Thickness Endoscopic Suturing for Weight Regain after Gastric Bypass: A Large Multicenter International Experience and Meta-Analysis