A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video).

BACKGROUND AND AIMS: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. METHODS: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. RESULTS: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ± .8; SEMS-V, 2.5 ± .8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [-17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P = .96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P = .61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P = .29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group. CONCLUSIONS: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.).

Safety and efficacy of lumen-apposing metal stents with and without simultaneous double-pigtail plastic stents for draining pancreatic pseudocyst.

BACKGROUND AND AIMS: Lumen-apposing metal stents (LAMSs) are used to perform necrosectomy in walled-off necrosis (WON). Although necrosectomy is not required for pancreatic pseudocyst (PP), an increasing number of PPs are also being drained with LAMSs in view of their ease of deployment. The aim of the present study was to evaluate the safety and efficacy of using LAMSs to drain PPs. METHODS: At 1 tertiary center from January 2014 to May 2016, all consecutive patients with PPs were drained by LAMSs, and the data were retrospectively reviewed. After observing cyst-cavity infection in patients enrolled initially (group I), 10F double-pigtail stents (DPSs) were placed across LAMSs in the subsequent patients (group II). Data on technical success, PP resolution, adverse events, and reintervention rates were collected. RESULTS: Forty-seven patients with PPs (mean size, 9.5 ± 4.0 cm) were enrolled (group I, 24; group II, 23). There was 1 perforation at deployment (technical success, 98%). In the remaining 46 patients, resolution of the PP was observed in 44 patients (96%). Four patients (17%) in group I presented with PP infection requiring reinterventions. Food material was observed in the cyst cavity. None of the patients in group II had PP infection (relative risk, .84; 95% confidence interval, .71-1.0; P = .054). CONCLUSIONS: Similar to WON, LAMSs are also effective in endoscopic drainage of PPs. However, there was a trend toward higher PP infection with LAMSs, and placing a DPS across the LAMS minimized this risk.

Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass.

BACKGROUND AND AIMS: The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases, yet standard ERCP is not possible because of surgically altered gastroduodenal anatomy. Laparoscopy-assisted ERCP (LA-ERCP) has been proposed as an option, but supporting data are derived from single-center small case series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP. METHODS: This is a retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all the following were achieved: reaching the papilla, cannulating the desired duct, and providing endoscopic therapy as clinically indicated. RESULTS: A total of 579 patients (median age, 51; 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (interquartile range [IQR], 109-210), with a median ERCP time of 40 minutes (IQR, 28-56). Median hospital stay was 2 days (IQR, 1-3). Adverse events were 18% (laparoscopy related, 10%; ERCP related, 7%; both, 1%) with the clear majority (92%) classified as mild/moderate, whereas 8% were severe and 1 death occurred. CONCLUSIONS: Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. The ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher because of the added laparoscopy-related events.

Endoscopic Management of Difficult Bile Duct Stones.

PURPOSE OF REVIEW: In 10-15% of the cases, conventional methods for removing bile duct stones by ERCP/balloon-basket extraction fail. The purpose of this review is to describe endoscopic techniques in managing these "difficult bile duct stones." RECENT FINDINGS: Endoscopic papillary large balloon dilation with balloon extraction ± mechanical lithotripsy is the initial approach used to retrieve large bile duct stones. With advent of digital cholangioscopy, electrohydraulic and laser lithotripsy are gaining popularity. Enteroscopy-assisted or laparoscopic-assisted approaches can be used for those with gastric bypass anatomy. Difficulties in removing bile duct stones can be related to stone-related factors such as the size and location of the stone or to altered anatomy such as stricture in the bile duct or Roux-en-Y anatomy. Several endoscopy approaches and techniques have described in the recent past that have greatly enhanced our ability to remove these "difficult" bile duct stones.

Covered Esophageal Stenting Is Effective for Symptomatic Gastric Lumen Narrowing and Related Complications Following Laparoscopic Sleeve Gastrectomy.

BACKGROUND AND STUDY AIMS: Laparoscopic sleeve gastrectomy (LSG) is gaining popularity in treating morbid obesity. Prior studies showed a 3.5% risk of gastric sleeve stenosis (GSS). There is no consensus on how to treat these patients, and the role of endoscopic therapy has been addressed in only a few studies. We aim to assess the efficacy and safety of endoscopic stenting in the management of GSS following LSG. PATIENTS AND METHODS: Retrospective data were reviewed from July 2009 to November 2013. Patients were referred for endoscopic therapy for symptoms or imaging findings suggestive of gastric leak or narrowing following LSG. Endoscopic therapy included the use of fully covered self-expanding esophageal metal stents (FCSEMS) in addition to over-the-scope clip system (OTSC) when necessary. RESULTS: All 27 patients were females with mean age of 40 years; six patients were excluded from the study. Major symptom was nausea and vomiting in 57% of the patients. Five of 21 patients had concomitant leaks. All 21 patients underwent FCSEMS placement, and four out of five patients (80%) with concomitant leak had OTSC. The success rate in both groups for resolution of stricture and leak was 100%, and no surgical intervention was required. There were no immediate or delayed complications of endoscopic therapy. Median follow-up of 6 months was available for 20/21 patients. Among patients with gastric leak, 80% had resolution of their symptoms compared with 93% of patients with GSS. CONCLUSIONS: Endoscopic therapy for LSG-related GSS or leaks with FCSEMS is highly effective and safe.

A Novel Protocol Obviates Endoscope Sampling for Carbapenem-Resistant Enterobacteriaceae: Experience of a Center with a Prior Outbreak.

BACKGROUND: Numerous published outbreaks, including one from our institution, have described endoscope-associated transmission of multidrug-resistant organisms (MDROs). Individual centers have adopted their own protocols to address this issue, including endoscope culture and sequestration. Endoscope culturing has drawbacks and may allow residual bacteria, including MDROs, to go undetected after high-level disinfection. AIM: To report the outcome of our novel protocol, which does not utilize endoscope culturing, to address our outbreak. METHODS: All patients undergoing procedures with elevator-containing endoscopes were asked to permit performance of a rectal swab. All endoscopes underwent high-level disinfection according to updated manufacturer's guidance. Additionally, ethylene oxide (EtO) sterilization was done in the high-risk settings of (1) positive response to a pre-procedure risk stratification questionnaire, (2) positive or indeterminate CRE polymerase chain reaction (PCR) from rectal swab, (3) refusal to consent for PCR or questionnaire, (4) purulent cholangitis or infected pancreatic fluid collections. Two endoscopes per weekend were sterilized on a rotational basis. RESULTS: From September 1, 2015 to April 30, 2016, 556 endoscopy sessions were performed using elevator-containing endoscopes. Prompted EtO sterilization was done on 46 (8.3%) instances, 3 from positive/indeterminate PCR tests out of 530 samples (0.6%). No CRE transmission was observed during the study period. Damage or altered performance of endoscopes related to EtO was not observed. CONCLUSION: In this pilot study, prompted EtO sterilization in high-risk patients has thus far eliminated endoscope-associated MDRO transmission, although no CRE infections were noted throughout the institution during the study period. Further studies and a larger patient sample will be required to validate these findings.

Neoadjuvant treatment sequencing adds value to the care of patients with operable pancreatic cancer.

Treatment sequencing for resectable pancreatic cancer remains controversial and there is lack of level one evidence comparing neoadjuvant versus adjuvant strategies. However, a comparison of the cost-effectiveness analysis of the treatment strategies may help to better define the healthcare value of each approach. This review will highlight the rationale for multimodality therapy in the treatment of pancreatic cancer, discuss the advantages and disadvantages of adjuvant therapy, and conceptualize the cost-effectiveness of a neoadjuvant approach with regard to healthcare value. J. Surg. Oncol. 2016;114:291-295. © 2016 Wiley Periodicals, Inc.