Barham K. Abu Dayyeh

Gastrojejunal Stoma Diameter Predicts Weight Regain after Roux-en-Y Gastric Bypass

BACKGROUND & AIMS Weight regain after Roux-en-Y gastric bypass (RYGB) is associated with reductions in health status and quality of life. We evaluated whether gastrojejunal stoma diameter is a risk factor for weight regain after RYGB. METHODS We examined data collected over 4 years from consecutive patients referred to a tertiary care bariatric center for upper endoscopy after RYGB. We used linear regression analysis to determine the association between the gastrojejunal stoma diameter and weight regain. We applied a logistic regression model using clinical and endoscopic parameters to develop a prediction rule for weight gain after RYGB. RESULTS Among 165 patients included in our study, 59% had significant weight regain (≥ 20% of maximum weight lost after the RYGB) and 41% did not. The mean percentage of maximal weight lost after RYGB that was regained in the entire cohort was 30% ± 22%. Gastrojejunal stoma diameter was associated significantly with weight regain after RYGB surgery in univariate analysis (β = .31, P < .0001). This association remained significant after adjusting for several known or purported risk factors for weight regain (β = .19, P = .003). We developed a simple prediction rule for weight regain after RYGB using a 7-point scoring system that includes the gastrojejunal stoma diameter, race, and percentage of maximal body weight lost after RYGB; a cut-off score of 4 or more points had an area under receiver operating characteristic curve of 0.76 and a positive predictive value of 75%. CONCLUSIONS Increased gastrojejunal stoma diameter is a risk factor for weight regain after RYGB and can be incorporated in a novel prediction rule.

ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies

The increasing global burden of obesity and its associated comorbidities has created an urgent need for additional treatment options to fight this pandemic. Endoscopic bariatric therapies (EBTs) provide an effective and minimally invasive treatment approach to obesity that would increase treatment options beyond surgery, medications, and lifestyle measures. This systematic review and meta-analysis were performed by the American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force comprising experts in the subject area and the ASGE Technology Committee Chair to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of available EBTs have been met. After conducting a comprehensive search of several English-language databases, we performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery, Austin, Tex) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics, Lexington, Mass) have met the PIVI thresholds. The meta-analyses results indicate that the Orbera IGB meets the PIVI thresholds for both primary and nonprimary bridge obesity therapy. Based on a meta-analysis of 17 studies including 1683 patients, the percentage of excess weight loss (%EWL) with the Orbera IGB at 12 months was 25.44% (95% confidence interval [CI], 21.47%-29.41%) (random model) with a mean difference in %EWL over controls of 26.9% (95% CI, 15.66%-38.24%; P ≤ .01) in 3 randomized, controlled trials. Furthermore, the pooled percentage of total body weight loss (% TBWL) after Orbera IGB implantation was 12.3% (95% CI, 7.9%–16.73%), 13.16% (95% CI, 12.37%–13.95%), and 11.27% (95% CI, 8.17%–14.36%) at 3, 6, and 12 months after implantation, respectively, thus exceeding the PIVI threshold of 5% TBWL for nonprimary (bridge) obesity therapy. With the data available, the DJBS liner does appear to meet the %EWL PIVI threshold at 12 months, resulting in 35% EWL (95% CI, 24%-46%) but does not meet the 15% EWL over control required by the PIVI. We await review of the pivotal trial data on the efficacy and safety of this device. Data are insufficient to evaluate PIVI thresholds for any other EBT at this time. Both evaluated EBTs had ≤5% incidence of serious adverse events as set by the PIVI document to indicate acceptable safety profiles. Our task force consequently recognizes the Orbera IGB for meeting the PIVI criteria for the management of obesity. As additional data from the other EBTs become available, we will update our recommendations accordingly.

A Functional Polymorphism in the Epidermal Growth Factor Gene Is Associated With Risk for Hepatocellular Carcinoma

BACKGROUND & AIMS A single nucleotide polymorphism 61*G (rs4444903) in the epidermal growth factor (EGF) gene has been associated, in 2 case-control studies, with hepatocellular carcinoma (HCC). We tested associations between demographic, clinical, and genetic data and development of HCC, and developed a simple predictive model in a cohort of patients with chronic hepatitis C and advanced fibrosis. METHODS Black and white subjects from the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) trial (n=816) were followed up prospectively for development of a definite or presumed case of HCC for a median time period of 6.1 years. We used the Cox proportional hazards regression model to determine the hazard ratio for risk of HCC and to develop prediction models. RESULTS Subjects with EGF genotype G/G had a higher adjusted risk for HCC than those with genotype A/A (hazard ratio, 2.10; 95% confidence interval, 1.05-4.23; P=.03). After adjusting for EGF genotype, blacks had no increased risk of HCC risk compared with whites. Higher serum levels of EGF were observed among subjects with at least one G allele (P=.08); the subset of subjects with EGF G/G genotype and above-median serum levels of EGF had the highest risk of HCC. We developed a simple prediction model that included the EGF genotype to identify patients at low, intermediate, and high risk for HCC; 6-year cumulative HCC incidences were 2.3%, 10.4%, and 26%, respectively. CONCLUSIONS We associated the EGF genotype G/G with increased risk for HCC; differences in its frequency among black and white subjects might account for differences in HCC incidence between these groups. We developed a model that incorporates EGF genotype and demographic and clinical variables to identify patients at low, intermediate, and high risk for HCC.

Endoscopic submucosal dissection

ESD is an established effective treatment modality for premalignant and early-stage malignant lesions of the stomach, esophagus, and colorectum. Compared with EMR, ESD is generally associated with higher rates of en bloc, R0, and curative resections and a lower rate of local recurrence. Oncologic outcomes with ESD compare favorably with competing surgical interventions, and ESD also serves as an excellent T-staging tool to identify noncurative resections that will require further treatment. ESD is technically demanding and has a higher rate of adverse events than most endoscopic procedures including EMR. As such,sufficient training is critical to ensure safe conduct and high-quality resections. A standardized training model for Western endoscopists has not been clearly established,but will be self-directed and include courses, animal model training, and optimally an observership at an expert center.Numerous dedicated ESD devices are now available in the United States from different manufacturers. Although the use of ESD in the United States is increasing, issues related to technical difficulty, limited training opportunities and mentors, risk of adverse events, long procedure duration,and suboptimal reimbursement may limit ESD adoption in the United States to a modest number of academic referral centers for the foreseeable future.

Endoscopic sleeve gastroplasty: A potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity

BACKGROUND Obesity and its associated conditions, including type 2 diabetes and cardiovascular disease, have reached epidemic proportions. High-efficacy, high-risk surgical approaches are unlikely to meet the increasing burden of disease. Emerging endoscopic technologies have opened the door for endoscopic approaches to reproduce many of the benefits of GI weight loss surgery and thereby contribute to the effective treatment of obesity and its associated disorders. OBJECTIVE To demonstrate the technical feasibility of transoral endoscopic gastric volume reduction with an endoscopic suturing device in a fashion similar to sleeve gastrectomy for the treatment of obesity. DESIGN Single-center, pilot feasibility study. PATIENTS Four human subjects with obesity. INTERVENTIONS Transoral sleeve gastroplasty. MAIN OUTCOME MEASUREMENTS Technical feasibility. RESULTS We successfully used an endoscopic free-hand suturing system in 4 subjects, thus demonstrating the technical feasibility of a novel technique to mimic the anatomic manipulations created by surgical sleeve gastrectomy endoscopically. LIMITATIONS Pilot feasibility study with small number of subjects. CONCLUSIONS Endoscopic sleeve gastroplasty for treatment of obesity is feasible.

Rectal Nonsteroidal Anti-inflammatory Drugs Are Superior to Pancreatic Duct Stents in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: A Network Meta-analysis

BACKGROUND & AIMS Placement of pancreatic duct (PD) stents prevents pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). There is evidence that rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs) also prevents post-ERCP pancreatitis, but the 2 approaches alone have not been compared directly. We conducted a network meta-analysis to indirectly compare the efficacies of these procedures. METHODS PubMed and Embase were searched by 2 independent reviewers to identify full-length clinical studies, published in English, investigating use of PD stent placement and rectal NSAIDs to prevent post-ERCP pancreatitis. We identified 29 studies (22 of PD stents and 7 of NSAIDs). We used network meta-analysis to compare rates of post-ERCP pancreatitis among patients who received only rectal NSAIDs, only PD stents, or both. RESULTS Placement of PD stents and rectal administration of NSAIDs were each superior to placebo in preventing post-ERCP pancreatitis. The combination of rectal NSAIDs and stents was not superior to either approach alone. Pooled results showed that rectal NSAIDs alone were superior to PD stents alone in preventing post-ERCP pancreatitis (odds ratio, 0.48; 95% confidence interval, 0.26-0.87). CONCLUSIONS Based on a network meta-analysis, rectal NSAIDs alone are superior to PD stents alone in preventing post-ERCP pancreatitis, and should be considered first-line therapy for selected patients. However, these findings were limited by the small number of studies assessed (only 29 studies), potential publication bias, and the indirect nature of the comparison. High-quality, randomized, controlled trials are needed to compare these 2 interventions and confirm these findings.

The effect of angiotensin-blocking agents on liver fibrosis in patients with hepatitis C.

Background: Multiple studies implicate the renin–angiotensin system in hepatic fibrogenesis. Few studies have examined the effects of angiotensin blockade on liver fibrosis via human histology.

EUS-guided pancreatic duct intervention: outcomes of a single tertiary-care referral center experience.

BACKGROUND EUS can provide access to the main pancreatic duct (MPD) for therapeutic intervention. The long-term clinical success of EUS-guided MPD interventions is unknown. OBJECTIVE To determine technical and clinical success rates, predictors of success, and long-term outcomes of EUS-guided MPD intervention. DESIGN Retrospective, single-center study. SETTING Tertiary-care referral center. PATIENTS Forty-five patients. INTERVENTION EUS-guided MPD stent retrieval or placement. MAIN OUTCOME MEASUREMENTS Technical and clinical success rates, adverse events, and long-term clinical outcomes. RESULTS Among the 45 patients, 37 had undergone failed ERCP, and 29 had surgically altered anatomy. Median follow-up after initial EUS-guided intervention was 23 months. Two patients underwent EUS for stent removal, and EUS-guided MPD stent placement was attempted in 43 patients. Technical success was achieved in 32 of 43 patients (74%) with antegrade (n = 18) or retrograde (n = 14) stent insertion. Serious adverse events occurred in 3 patients (6%). Patients underwent a median of 2 (range 1-6) follow-up procedures for revision or removal of stents, without adverse events. Complete symptom resolution occurred in 24 of 29 patients (83%) while stents were in place, including all 6 with nondilated ducts. Stents were removed in 23 patients, who were then followed for an additional median of 32 months; 4 patients had recurrent symptoms. Among the 11 failed cases, most had persistent symptoms or required surgery. LIMITATIONS Retrospective study design, individualized patient management. CONCLUSION EUS-guided MPD intervention is feasible and safe, with long-term clinical success in the majority of patients. EUS provides important treatment options, particularly in patients who would otherwise undergo surgery.

Endoscopic bariatric therapies

The ASGE Technology Committee provides reviews of its associated comorbid conditions including hypertenexisting, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events of a given technology. Both are supplemented by accessing the “related articles” feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. This Technology Status Evaluation Report is drafted by 1 comember of the ASGE Technology Committee and the Bariatric Endoscopy Task Force (B.K.A.D.). It was reviewed and edited by the entire ASGE Bariatric Endoscopy Task Force and the Chair of the ASGE Technology Committee and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through December 2014 for relevant articles by using the key words “bariatric,” “endoscopic,” “intragastric balloon,” “bypass sleeve,” “gastroplasty,” and “aspiration therapy.” Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

Endoscopic sclerotherapy for the treatment of weight regain after Roux-en-Y gastric bypass: outcomes, complications, and predictors of response in 575 procedures.

BACKGROUND Weight regain after Roux-en-Y gastric bypass (RYGB) is common. Endoscopic sclerotherapy is increasingly used to treat this weight regain. OBJECTIVES To report safety, outcomes, durability, and predictors of response to sclerotherapy in a large prospective cohort. DESIGN Retrospective analysis of a prospective cohort study of patients with weight regain after RYGB. PATIENTS A total of 231 consecutive patients undergoing 575 sclerotherapy procedures between September 2008 and March 2011. INTERVENTIONS Single or multiple sclerotherapy procedures to inject sodium morrhuate into the rim of the gastrojejunal anastomosis. MAIN OUTCOME MEASUREMENTS We report weight loss, complications, and predictors of response. We also used Kaplan-Meier survival analysis and log-rank test to compare time to continuation of weight regain after sclerotherapy in patients undergoing a single versus multiple sclerotherapy procedures. RESULTS At 6 and 12 months from the last sclerotherapy procedure, weight regain stabilized in 92% and 78% of the cohort, respectively. Those who underwent 2 or 3 sclerotherapy sessions had significantly higher rates of weight regain stabilization than those who underwent a single session (90% vs 60% at 12 months; P = .003). The average weight loss at 6 months from the last sclerotherapy session for the entire cohort was 10 lb (standard deviation 16), representing 18% of the weight regained after RYGB. A subset of 73 patients (32% of the cohort) had greater weight loss at 6 months (26 lb, standard deviation 12), representing 61% of the weight regained. Predictors of a favorable outcome included greater weight regain and the number of sclerotherapy procedures. Bleeding was reported in 2.4% of procedures and transient diastolic blood pressure increases in 15%, without adverse health outcomes. No GI perforations were reported. CONCLUSIONS Endoscopic sclerotherapy appears to be a safe and effective tool for the management of weight regain after RYGB.