Christopher C. Thompson

Endoscopic transgastric abdominal exploration and organ resection: initial experience in a porcine model.

BACKGROUND & AIMS The evolution of flexible endoscopes and endoscopic devices has recently enabled per-oral transgastric abdominal exploration in animal models. This study was undertaken to assess the ability to systematically identify abdominopelvic organs and to determine the feasibility of organ resection via the transgastric route. METHODS Female Yorkshire pigs were used for the study. Under general anesthesia, a gastroscope was used to place a sterile overtube into the esophagus. After antibacterial lavage, the gastric wall was incised, and a sterile dual-channel endoscope was advanced into the peritoneal cavity. Endoscopic abdominal exploration was then methodically performed in 9 animals with oophorectomy and partial hysterectomy in 6 animals. The gastric incision was closed with endoclips. Of the animals that underwent organ resection, 3 were sacrificed immediately after surgery, and the subsequent 3 survived. RESULTS The peritoneal cavity was accessed uneventfully, and the stomach, liver, small bowel, colon, urinary bladder, uterus, fallopian tubes, and ovaries were able to be evaluated in all cases. The gallbladder could be visualized in only 5 of the 9 animals, and retroperitoneal structures could not be consistently identified. Oophorectomy with partial hysterectomy was performed in 6 animals. The 3 animals in the survival group did well for 24 hours without sequelae. CONCLUSIONS This study shows the ability of endoscopic transgastric peritoneal exploration to successfully identify most abdominopelvic organs and demonstrates the technical feasibility of transgastric organ resection.

Ethanol lavage of pancreatic cystic lesions: initial pilot study

BACKGROUND Ethanol lavage has been used to successfully and safely ablate cystic lesions of the liver, the kidneys, and the thyroid. METHODS Asymptomatic patients who undergo EUS examination for a pancreatic cystic lesion were eligible. Patients underwent complete examination with a linear-array echoendoscope, and cyst characteristics were documented. After evacuation of the cyst with needle aspiration, the cyst cavity was lavaged with ethanol for 3 to 5 minutes. The concentration (5%-80%) of ethanol was gradually increased over the course of the study. Patients were monitored for complications during 2 hours after the procedure, and further follow-up was obtained at 72 hours and 1 year after lavage. OBSERVATIONS Twenty-five patients were enrolled, 80% were women, and the mean age of all patients was 64.5 years. Cysts had a mean diameter of 19.4 mm and were equally located in the head, the body, and the tail of the pancreas. Cyst-fluid characteristics included high viscosity in 13 (52%) and a mean carcinoembryonic antigen and amylase of 5916 ng/mL and 11,506 U/L, respectively. None of the patients reported any symptoms in short- and long-term follow-up. Of the 23/25 patients with complete follow-up, 8 patients (35%) had complete resolution of their cysts on follow-up imaging. Five patients underwent resection, and histologic evidence of epithelial ablation was seen. CONCLUSIONS Ethanol lavage of pancreatic cystic lesions is safe and feasible. A subset of patients undergoing ethanol lavage appears to have long-term resolution on follow-up imaging. Further prospective studies are required to determine if ethanol lavage is an effective treatment for pancreatic cystic lesions.

A randomized trial comparing uncovered and partially covered self- expandable metal stents in the palliation of distal malignant biliary obstruction

BACKGROUND The most common complication of uncovered biliary self-expandable metal stents (SEMSs) is tumor ingrowth. The addition of an impenetrable covering may prolong stent patency. OBJECTIVE To compare stent patency between uncovered and partially covered SEMSs in malignant biliary obstruction. DESIGN Multicenter randomized trial. SETTING Four teaching hospitals. PATIENTS Adults with inoperable distal malignant biliary obstruction. INTERVENTIONS Uncovered or partially covered SEMS insertion. MAIN OUTCOME MEASURES Time to recurrent biliary obstruction, patient survival, serious adverse events, and mechanism of recurrent biliary obstruction. RESULTS From October 2002 to May 2008, 129 patients were randomized. Recurrent biliary obstruction was observed in 11 of 61 uncovered SEMSs (18%) and 20 of 68 partially covered SEMSs (29%). The median times to recurrent biliary obstruction were 711 days and 357 days for the uncovered and partially covered SEMS groups, respectively (P = .530). Median patient survival was 239 days for the uncovered SEMS and 227 days for the partially covered SEMS groups (P = .997). Serious adverse events occurred in 27 (44%) and 42 (62%) patients in the uncovered and partially covered SEMS groups, respectively (P = .046). None of the uncovered and 8 (12%) of the partially covered SEMSs migrated (P = .0061). LIMITATIONS Intended sample size was not reached. Allocation to treatment groups was unequal. CONCLUSIONS There was no significant difference in time to recurrent biliary obstruction or patient survival between the partially covered and uncovered SEMS groups. Partially covered SEMSs were associated with more serious adverse events, particularly migration.

EUS-guided fine needle aspiration of pancreatic cysts: A retrospective analysis of complications and their predictors

BACKGROUND AND AIMS Endoscopic ultrasound-guided fine-needle aspiration (EUS FNA) of pancreatic cysts is considered safe, however, data are conflicting regarding complication rates. The aim of this study was to determine the complication rate of EUS-guided pancreatic cyst aspiration and predictors of these complications. METHODS Results of pancreatic cyst EUS FNA at 2 academic institutions from March 1996 to October 2003 were reviewed. A total of 603 patients with 651 pancreatic cysts were evaluated. Complications were identified from clinic, emergency department, and discharge notes, and laboratory and radiologic data. Data collected were as follows: cyst size, location, septations, diagnosis, number of passes, needle size, status as inpatient or outpatient, performance of same-day endoscopic retrograde cholangiopancreatography (ERCP), and use of prophylactic antibiotics. RESULTS Complications were identified in 13 patients (2.2%, 13 of 603): 6 patients had pancreatitis, 4 patients had abdominal pain, 1 patient had a retroperitoneal bleed, 1 patient had an infection, and 1 patient had bradycardia. Twelve patients required hospitalization, with an average length of stay of 3.8 +/- 1.1 days. Type of cyst, size, presence of septations or mass, and same-day ERCP were not predictors of complications. CONCLUSIONS EUS-guided pancreatic cyst aspiration carries a low complication rate similar to that reported for solid pancreatic lesions. No patient or cyst characteristics appear to be predictive of adverse events.

Use of self-expandable stents in the treatment of bariatric surgery leaks: a systematic review and meta-analysis

BACKGROUND Bariatric surgery leaks can result in significant morbidity and mortality. Endoscopic placement of self-expandable stents (SESs) is emerging as a less-invasive alternative to surgery for the treatment of leaks. OBJECTIVE To evaluate the success of SESs in the treatment of bariatric surgery leaks. DESIGN Studies using SESs in the management of bariatric surgery leaks were selected. Success of SES treatment was defined as radiographic evidence of leak closure after stent removal. Articles were searched in MEDLINE, PubMed, Ovid, and Cochrane Register of Controlled Trials. Pooled proportions were calculated by using fixed- and random-effects models. Publication bias was calculated by using the Begg-Mazumdar and Harbord bias estimators. RESULTS A total of 189 relevant articles were reviewed of which 7 studies (67 patients with leaks) met inclusion criteria. The pooled proportion of successful leak closures by using SESs was 87.77% (95% CI, 79.39%-94.19%). The pooled proportion of successful endoscopic stent removal was 91.57% (95% CI, 84.22%-96.77%). Stent migration was noted in 16.94% (95% CI, 9.32%-26.27%). Test of heterogeneity gave a P value >.10. There was no publication bias. LIMITATIONS Small retrospective studies, different types of stents used. CONCLUSION Endoscopic placement of SESs is a minimally invasive, safe, and effective alternative in the management of leaks after bariatric surgery. The use of SESs can minimize the need for surgical revision and improve patient outcomes.

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.

Surgery Insight: natural orifice transluminal endoscopic surgery—an analysis of work to date

Traditional flexible endoscopy has been limited to the confines of the gastrointestinal lumen; however, recent developments involving transluminal access to intra-abdominal structures hold the potential to revolutionize flexible endoscopy. Over the past few years various studies have detailed techniques that intentionally breach the lumen and provide endoscopic access to the peritoneal cavity for diagnostic and therapeutic procedures. Unlike standard surgical approaches, which require incisions to be made in the abdominal wall, natural orifice transluminal endoscopic surgery (NOTES) avoids the need for abdominal incisions and can offer specific advantages to select patient populations. Animal models have been used to demonstrate the possible applications of NOTES, including transgastric peritoneoscopy, tubal ligation, gastrojejunostomy, partial hysterectomy, oophorectomy, and transcolonic exploration, liver biopsy and cholecystectomy. In this Review, we highlight important advances in NOTES since it was first described and analyze the hazards and potential benefits associated with this innovative approach.

Marginal ulceration after Roux-en-Y gastric bypass surgery: characteristics, risk factors, treatment, and outcomes.

BACKGROUND AND STUDY AIMS Marginal ulcers are one of the most common complications after gastric bypass. Reported incidence varies widely (0.6-16 %) and pathogenesis is unclear. The aim of the present study was to describe characteristics, risk factors, management, and outcomes of endoscopically documented ulcers. PATIENTS AND METHODS Data from all patients diagnosed with marginal ulcers at endoscopy between 2003 and 2010 were retrospectively reviewed. RESULTS A total of 103 patients with marginal ulcers presented with pain (63 %) and/or bleeding (24 %), a median of 22 months after surgery. Ulcers were located on the anastomosis (50 %) or the jejunum (40 %); sutures were visible in 35 %, and gastrogastric fistulae in 8 %. The mean pouch length was 5.6 cm. Diabetes (odds ratio [OR] 2.5; P = 0.03), smoking (OR 2.5; P = 0.02), and gastric pouch length (OR 1.2; P = 0.02) were significantly associated with marginal ulcer formation on univariate analysis; diabetes was significantly associated on multivariate analysis (OR 5.6; P = 0.003). The risk of developing a marginal ulcer decreased with time (OR 0.8; P < 0.01) and was not associated with the use of nonsteroidal anti-inflammatory drugs. At first endoscopic follow-up, 67 % of ulcers had healed. Recurrence occurred in four patients and nine patients required surgical revision. CONCLUSIONS The vast majority of marginal ulcers had a favorable outcome after medical treatment. However, 9 % of patients eventually required surgical revision. Therefore, endoscopic follow-up is essential. Diabetes, smoking, and long gastric pouches were significant risk factors for marginal ulcer formation, suggesting increased acid exposure and mucosal ischemia are both involved in marginal ulcer pathogenesis. Management of these factors may prove effective in managing marginal ulcers, and tailoring postoperative proton pump inhibitor therapy to patients with multiple risk factors could be effective.

Endoscopic repair of gastrogastric fistula after Roux-en-Y gastric bypass: a less-invasive approach.

BACKGROUND Gastrogastric fistulas (GGFs) are a well-known complication of Roux-en-Y gastric bypass. Surgical repair of such fistulas is technically difficult, with significant associated morbidity. The aim of the present study was to evaluate the efficacy of endoscopic GGF closure at a university hospital in the United States. METHODS Patients with Roux-en-Y gastric bypass and confirmed GGFs on esophagogastroduodenoscopy or barium study. Endoscopic repair was performed with the EndoCinch suturing system (group 1) or clips (group 2). All patients were followed up in the outpatient clinic or interviewed by telephone at 1, 6, and 18 months after the procedure, then as indicated by symptoms. RESULTS A total of 95 patients were included in the present series (group 1, n = 71, 75%; group 2, n = 24, 25%). The mean GGF size was significantly larger in group 1 than in group 2 (14.5 +/- 8.7 versus 7.7 +/- 6, P = .01). An average of 2.2 sutures or 3 clips (range 2-7) was used. Complete initial GGF closure was achieved in 90 patients (95%), with reopening in 59 (65%) an average of 177 +/- 202 days. The average follow-up was 395 +/- 49 days, with 22 patients lost to follow-up. Two significant complications were reported (bleeding and an esophageal tear). None of the GGFs with an initial size >20 mm remained closed during the follow-up period compared with 10 (32%) of the 31 fistulas <or=10 mm in diameter remained closed. CONCLUSION Peroral endoscopic repair of postbariatric GGFs is technically feasible and safe but with limited durability. The fistula size predicted for long-term outcomes, with the best results seen in fistulas <or=10 mm in diameter.