Utility of methylated DNA markers for the diagnosis of malignant biliary strictures.

BACKGROUND AND AIMS: Early identification of malignant biliary strictures (MBS) is challenging, with up to 20% classified as indeterminants after preliminary testing and tissue sampling with endoscopic retrograde cholangiopancreatography (ERCP). We aimed to evaluate the use of methylated DNA markers (MDM) from biliary brushings to enhance MBS detection in a prospective cohort. METHODS: Candidate MDMs were evaluated for their utility in MBS diagnosis through a series of discovery and validation phases. DNA was extracted from biliary brushing samples, quantified, bisulfite-converted, and then subjected to methylation-specific Droplet Digital Polymerase Chain Reaction (ddPCR).  Patients were considered to have no malignancy if the sampling was negative and there was no evidence of malignancy after 1 year or definitive negative surgical histopathology. RESULTS: Fourteen candidate MDMs were evaluated in the discovery phase, with top-performing and new markers evaluated in the technical validation phase. The top four MDMs were TWIST1, HOXA1, VSTM2B, and CLEC11A, which individually achieved AUC values of 0.82, 0.81, 0.83, and 0.78, respectively, with sensitivities of 59.4%, 53.1%, 62.5%, and 50.0%, respectively, at high specificities for malignancy of 95.2-95.3% for the final biologic validation phase. When combined as a panel, the AUC was 0.86, achieving 73.4% sensitivity and 92.9% specificity, which outperformed cytology and fluorescent in situ hybridization (FISH). CONCLUSIONS: The selected methylated DNA markers demonstrated improved performance characteristics for the detection of MBS compared to cytology and FISH. ​ Therefore, MDMs should be considered viable candidates for inclusion in diagnostic testing algorithms.​.

Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial.

OBJECTIVE: We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection. SUMMARY BACKGROUND DATA: Randomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON. DESIGN: We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events. RESULTS: Forty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths. CONCLUSIONS: Endoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.

A Protocolized Management of Walled-Off Necrosis (WON) Reduces Time to WON Resolution and Improves Outcomes.

BACKGROUND AND AIMS: Patients with infected or symptomatic walled-off necrosis (WON) have high morbidity and health care utilization. Despite the recent adoption of nonsurgical treatment approaches, WON management remains nonalgorithmic. We investigated the impact of a protocolized early necrosectomy approach compared with a nonprotocolized, clinician-driven approach on important clinical outcomes. METHODS: Records were reviewed for consecutive patients with WON who underwent a protocolized endoscopic drainage with a lumen-apposing metal stent (cases), and for patients with WON treated with a lumen-apposing metal stent at the same tertiary referral center who were not managed according to the protocol (control subjects). The protocol required repeat cross-sectional imaging within 14 days after lumen-apposing metal stent placement, with regularly scheduled endoscopic necrosectomy if WON diameter reduction was <50%. Control patients were treated according to their clinician's preference without an a priori strategy. Inverse probability of treatment weighting-adjusted analysis was used to evaluate the influence of being in the protocolized group on time to resolution. RESULTS: A total of 24 cases and 47 control subjects were included. There were no significant differences in baseline characteristics. Although numbers of endoscopies and necrosectomies were similar, cases had lower adverse event rates, shorter intensive care unit stay, and required nutritional support for fewer days. On matched multivariate Cox regression, cases had earlier WON resolution (hazard ratio, 5.73; 95% confidence interval, 2.62-12.5). This was confirmed in the inverse probability of treatment weighting-adjusted analysis (hazard ratio, 3.4; 95% confidence interval, 1.92-6.01). CONCLUSIONS: A protocolized strategy resulted in faster WON resolution compared with a discretionary approach without the need for additional therapeutic interventions, and with a better safety profile and decreased health care utilization.

Uncovered versus fully covered self-expandable metal stents for the management of distal malignant biliary obstruction.

BACKGROUND AND AIM: Self-expandable metal stents (SEMSs) are widely used for palliation of distal malignant biliary obstruction (dMBO). However, previous studies comparing the outcomes between uncovered SEMSs (UCSEMSs) and fully covered SEMSs (FCSEMSs) report conflicting results. This large cohort study aimed to compare the clinical outcomes between UCSEMSs and FCSEMSs for dMBO. METHODS: A retrospective cohort study was performed in patients with dMBO who underwent either UCSEMS or FCSEMS placement between May 2017 and May 2021. Primary outcomes were rates of clinical success, adverse events (AEs), and unplanned endoscopic reintervention. Secondary outcomes were types of AEs, intervention-free stent patency, and management and outcomes of stent occlusion. RESULTS: The cohort included 454 patients (364 in the UCSEMS group and 90 in the FCSEMS group). Median follow-up duration was 9.6 months and was similar between the 2 groups. Use of UCSEMSs and FCSEMSs had comparable clinical success (P = .250). However, use of UCSEMSs had significantly higher rates of AEs (33.5% vs 21.1%; P = .023) and unplanned endoscopic reintervention (27.0% vs 11.1%; P = .002). UCSEMSs had a higher rate of stent occlusion (26.9% vs 8.9%; P < .001) and shorter median time to stent occlusion (4.4 months vs 10.7 months; P = .002). Stent reintervention-free survival was higher in the FCSEMS group. FCSEMSs had a significantly higher rate of stent migration (7.8% vs 1.1%; P < .001), but patients in the FCSEMS group had similar rates of cholecystitis (.3% vs 1.1%; P = .872) and post-ERCP pancreatitis (6.3% vs 6.6%; P = .90). When UCSEMSs did occlude, placement of a coaxial plastic stent had a higher rate of stent reocclusion compared with coaxial SEMS placement (46.7% vs 19.7%; P = .007). CONCLUSION: FCSEMSs should be considered for the palliation of dMBO because of lower rates of AEs, longer patency rates, and lower rates of unplanned endoscopic intervention.

Novel classification system for walled-off necrosis: a step toward standardized nomenclature and risk-stratification framework.

BACKGROUND AND AIMS: The optimal therapeutic approach for walled-off necrosis (WON) is not fully understood, given the lack of a validated classification system. We propose a novel and robust classification system based on radiologic and clinical factors to standardize the nomenclature, provide a framework to guide comparative effectiveness trials, and inform the optimal WON interventional approach. METHODS: This was a retrospective analysis of patients who underwent endoscopic management of WON by lumen-apposing metal stent placement at a tertiary referral center. Patients were classified according to the proposed QNI classification system: quadrant ("Q"), represented an abdominal quadrant distribution; necrosis ("N"), denoted by the percentage of necrosis of WON; and infection ("I"), denoted as positive blood culture and/or systemic inflammatory response syndrome reaction with a positive WON culture. Two blinded reviewers classified all patients according to the QNI system. Patients were then divided into 2 groups: those with a lower QNI stratification (≤2 quadrants and ≤30% necrosis; group 1) and those with a higher stratification (≥3 quadrants, 2 quadrants with ≥30% necrosis, or 1 quadrant with >60% necrosis and infection; group 2). The primary outcome was mean time to WON resolution. Secondary procedural and clinical outcomes between the groups were compared. RESULTS: Seventy-one patients (75% men) were included and stratified by the QNI classification; group 1 comprised 17 patients and group 2, 54 patients. Patients in group 2 had a higher number of necrosectomies, longer hospital stays, and more readmissions. The mean time to resolution was longer in group 2 than in group 1 (79.6 ± 7.76 days vs 48.4 ± 9.22 days, P = .02). The mortality rate was higher in group 2 (15% vs 0%, P = .18). CONCLUSIONS: Despite the heterogeneous nature of WON in severe acute pancreatitis, a proposed QNI system may provide a standardized framework for WON classification to inform clinical trials, risk-stratify the disease course, and potentially inform an optimal management approach.

Lumen-apposing metal stents for the treatment of benign gastrointestinal tract strictures: a single-center experience and proposed treatment algorithm.

BACKGROUND: Lumen-apposing metal stents (LAMS) are an alternative therapeutic option for benign gastrointestinal (GI) tract strictures. Our study aimed to evaluate the safety and efficacy of LAMS for the management of benign GI strictures. METHODS: Consecutive patients who underwent a LAMS placement for benign luminal GI strictures at a tertiary care center between January 2014 and July 2021 were reviewed. Primary outcomes included technical success, early clinical success, and adverse events (AEs). Other outcomes included rates of stent migration and re-intervention after LAMS removal. RESULTS: One hundred and nine patients who underwent 128 LAMS placements (67.9% female, mean age of 54.3 ± 14.2 years) were included, and 70.6% of the patients had failed prior endoscopic treatments. The majority of strictures (83.5%) were anastomotic, and the most common stricture site was the gastrojejunal anastomosis (65.9%). Technical success was achieved in 100% of procedures, while early clinical success was achieved in 98.4%. The overall stent-related AE rate was 25%. The migration rate was 27.3% (35/128). Of these, five stents were successfully repositioned endoscopically. The median stent dwell time was 119 days [interquartile range (IQR) 68-189 days], and the median follow-up duration was 668.5 days [IQR: 285.5-1441.5 days]. The re-intervention rate after LAMS removal was 58.3%. CONCLUSIONS: LAMS is an effective therapeutic option for benign GI strictures, offering high technical and early clinical success. However, the re-intervention rate after LAMS removal was high. In select cases, using LAMS placement as destination therapy with close surveillance is a reasonable option.

Endoscopic ultrasound-guided versus percutaneous drainage for the management of post-operative fluid collections after distal pancreatectomy.

BACKGROUND: Post-operative pancreatic fluid collections (POPFCs) can be drained using percutaneous or endoscopic approaches. The primary aim of this study was to compare rates of clinical success between endoscopic ultrasound-guided drainage (EUSD) with percutaneous drainage (PTD) in the management of symptomatic POPFCs after distal pancreatectomy. Secondary outcomes included technical success, total number of interventions, time to resolution, rates of adverse events (AEs), and POPFC recurrence. METHODS: Adults who underwent distal pancreatectomy from January 2012 to August 2021 and developed symptomatic POPFC in the resection bed were retrospectively identified from a single academic center database. Demographic data, procedural data, and clinical outcomes were abstracted. Clinical success was defined as symptomatic improvement and radiographic resolution without requiring an alternate drainage modality. Quantitative variables were compared using a two-tailed t-test and categorical data were compared using Chi-squared or Fisher's exact tests. RESULTS: Of 1046 patients that underwent distal pancreatectomy, 217 met study inclusion criteria (median age 60 years, 51.2% female), of whom 106 underwent EUSD and 111 PTD. There were no significant differences in baseline pathology and POPFC size. PTD was generally performed earlier after surgery (10 vs. 27 days; p < 0.001) and more commonly in the inpatient setting (82.9% vs. 49.1%; p < 0.001). EUSD was associated with a significantly higher rate of clinical success (92.5% vs. 76.6%; p = 0.001), fewer median number of interventions (2 vs. 4; p < 0.001), and lower rate of POPFC recurrence (7.6% vs. 20.7%; p = 0.007). AEs were similar between EUSD (10.4%) and PTD (6.3%, p = 0.28), with approximately one-third of EUSD AEs due to stent migration. CONCLUSION: In patients with POPFCs after distal pancreatectomy, delayed drainage with EUSD was associated with higher rates of clinical success, fewer interventions, and lower rates of recurrence than earlier drainage with PTD.

Utility of Urgent Endoscopic Retrograde Cholangiopancreatography in Patients with Predicted Mild Acute Pancreatitis and Cholestasis.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) within 72 h is suggested for patients presenting with acute biliary pancreatitis (ABP) and biliary obstruction without cholangitis. This study aimed to identify if urgent ERCP (within 24 h) improved outcomes compared to early ERCP (24-72 h) in patients admitted with predicted mild ABP. METHODS: Patients admitted for predicted mild ABP defined as a bedside index of severity in acute pancreatitis score < 3 and underwent ERCP for biliary obstruction within 72 h of presentation during the study period were included. Patients with prior biliary sphincterotomy or surgically altered anatomy preventing conventional ERCP were excluded. The primary outcome was the development of moderately severe or severe pancreatitis based on the revised Atlanta classification. Secondary outcomes were the length of hospital stay, the need for ICU admission, and ERCP-related adverse events (AEs). RESULTS: Of the identified 166 patients, baseline characteristics were similar between both the groups except for the WBC count (9.4 vs. 8.3/µL; p < 0.044) and serum bilirubin level (3.0 vs. 1.6 mg/dL; p < 0.0039). Biliary cannulation rate and technical success were both high in the overall cohort (98.8%). Urgent ERCP was not associated with increased development of moderately severe pancreatitis (10.4% vs. 15.7%; p = 0.3115). The urgent ERCP group had a significantly shorter length of hospital stay [median 3 (IQR 2-3) vs. 3 days (IQR 3-4), p < 0.01]. CONCLUSION: Urgent ERCP did not impact the rate of developing more severe pancreatitis in patients with predicted mild ABP but was associated with a shorter length of hospital stay and a lower rate of hospital readmission.

Impact of trimodality sampling on detection of malignant biliary strictures compared with patients with primary sclerosing cholangitis.

BACKGROUND AND AIMS: Malignant biliary strictures can be difficult to diagnose, with up to 20% considered indeterminate after initial tissue sampling. This study aimed to determine the performance characteristics of transpapillary biopsy sampling (TPB) and fluorescence in situ hybridization (FISH) in isolation or in combination with standard brush cytology (BC) in patients who received trimodality sampling for biliary strictures. METHODS: This single-center retrospective cohort study included patients with biliary strictures undergoing ERCP with trimodality sampling between September 2014 and April 2019. Performance characteristics for each diagnostic test alone and in combination were calculated. RESULTS: Two hundred four patients underwent trimodality biliary sampling, including 104 (51.0%) with malignancy. The diagnostic sensitivity for malignancy with BC (17.3%) significantly improved with dual modality (BC+FISH, 58.7%; BC+TPB, 40.4%) or trimodality sampling (68.3%; P < .001 for all comparisons). Trimodality sampling improved diagnostic sensitivity for malignancy compared with BC+FISH (P = .002) and BC+TPB (P < .001). There was no statistically significant difference in the sensitivity of trimodality sampling in detecting cholangiocarcinoma (79.7%) compared with pancreatic cancer (62.5%; P = .1). Among 57 patients with primary sclerosing cholangitis (PSC), the sensitivity of detecting biliary malignancy (n = 20) was 20% for BC and significantly improved with the addition of FISH (80%; P < .001) but not with TPB (35.0%; P = .25). Trimodality sampling did not further improve diagnostic sensitivity (85%) over BC+FISH (80%) for malignancy in the setting of PSC (P = 1). CONCLUSIONS: Trimodality sampling improves the diagnostic sensitivity for the detection of malignant biliary strictures with no significant difference in sensitivity for cholangiocarcinoma compared with pancreatic cancer. However, in patients with PSC, trimodality sampling was not superior to BC+FISH.

Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis.

BACKGROUND AND AIMS: Select patients with acute cholecystitis (AC) are poor candidates for cholecystectomy. ERCP-guided transpapillary gallbladder (GB) drainage (ERGD) is one modality for nonoperative management of AC in these patients. Our primary aim was to evaluate long-term success of destination ERGD. Secondary aims were the rate of technical and clinical success, number of repeat procedures, rate of adverse events, and risk factors for recurrent AC. METHODS: Consecutive patients with AC who were not candidates for cholecystectomy underwent ERGD with attempted transpapillary GB plastic double-pigtail stent placement at a tertiary hospital from January 2008 to December 2019. Long-term success was defined as no AC after ERGD until 6 months, death, or reintervention. Technical success was defined as placement of at least 1 transpapillary stent into the GB and clinical success as resolution of AC symptoms with discharge from the hospital. RESULTS: Long-term success was achieved in 95.9% of patients (47/49), technical success in 96% (49/51), and clinical success 100% in those with technical success. Mild adverse events occurred in 5.9% (n = 3). Mean follow-up was 453 days after ERGD (range, 18-1879). A trend toward longer time to recurrence of AC was seen in patients with 2 rather than 1 GB stent placed (P = .13), and more repeat procedures were performed when a single stent was placed (P = .045). CONCLUSIONS: ERGD with transpapillary GB double-pigtail stent placement is a safe and effective long-term therapy for poor surgical candidates with AC. Risk factors for recurrence include stent removal and single-stent therapy. Double-stent therapy is not always technically feasible but may salvage failed single-stent therapy or recurrence after elective stent removal and may therefore be the preferred treatment modality.

Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity.

BACKGROUND AND AIMS: Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. METHODS: Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events. RESULTS: Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P = .840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P < .001). Serious adverse events were reported in 13 patients (6.5%). CONCLUSIONS: In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.).

Impact of disconnected pancreatic duct syndrome on endoscopic ultrasound-guided drainage of pancreatic fluid collections.

BACKGROUND: Endoscopic intervention for pancreatic fluid collections (PFCs) with disconnected pancreatic duct syndrome (DPDS) has been associated with failures and increased need for additional endoscopic and non-endoscopic interventions. The primary aim of this study was to determine the outcomes of endoscopic ultrasound (EUS)-guided transmural drainage of PFCs in patients with DPDS. METHODS: In patients undergoing EUS-guided drainage of PFCs from January 2013 to January 2018, demographic profiles, procedural indications and details, adverse events, outcomes, and subsequent interventions were retrospectively collected. Overall treatment success was determined by PFC resolution on follow-up imaging or stent removal without recurrence. RESULTS: EUS-guided drainage of PFCs was performed in 141 patients. DPDS was present in 57 of them (40 %) and walled-off necrosis was the most frequent type of PFC (55 %). DPDS was not associated with lower clinical success, increased number of repeat interventions, or increased time to PFC resolution. Patients with DPDS were more likely to be treated with permanent transmural plastic double-pigtail stents (odds ratio [OR] 6.4; 95 % confidence interval [CI] 2.5 - 16.5; P < 0.001). However, when stents were removed, DPDS was associated with increased PFC recurrence after stent removal (OR 8.0; 95 %CI 1.2 - 381.8; P = 0.04). CONCLUSIONS: DPDS frequently occurs in patients with PFCs but does not negatively impact successful resolution. DPDS is associated with increased PFC recurrence after stent removal.

Endoscopic full-thickness suturing plus argon plasma mucosal coagulation versus argon plasma mucosal coagulation alone for weight regain after gastric bypass: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Endoscopic transoral outlet reduction (TORe) has been used to manage weight regain after Roux-en-Y gastric bypass. We conducted a meta-analysis to summarize the efficacy and safety of the two most commonly used techniques: full-thickness suturing plus argon plasma mucosal coagulation (ft-TORe) and argon plasma mucosal coagulation alone (APMC-TORe). METHODS: A literature search of publication databases was performed from their inception to February 2020 for relevant studies. The outcomes of interest were percentage total body weight loss, gastrojejunal anastomosis (GJA) diameter, and adverse events (AEs). The pooled effect estimates were analyzed using a random-effects model. Meta-regression was conducted to identify associations between GJA diameter and weight loss. RESULTS: Nine ft-TORe (n = 737) and 7 APMC-TORe (n = 888) studies were included. APMC-TORe was performed as a series of sessions (mean number of sessions ranging from 1.2 to 3), whereas ft-TORe was mostly performed as a single session. Percentage total body weight loss was 8.0% (95% confidence interval [CI], 6.3%-9.7%), 9.5% (95% CI, 8.1%-11.0%), and 5.8% (95% CI, 4.3%-7.1%) after ft-TORe and 9.0% (95% CI, 4.1%-13.9%), 10.2% (95% CI, 8.4%-12.1%), and 9.5% (95% CI, 5.7%-13.2%) after APMC-TORe at 3, 6, and 12 months, respectively, with no weight-loss difference at 3 and 6 months (P > .05). Only one severe AE was observed after APMC-TORe and none after ft-TORe. Stricture formation was the most common AE (ft-TORe 3.3% and APMC-TORe 4.8%, P = .38). All were successfully treated by endoscopic dilation or conservative treatment. Smaller aperture of the post-TORe GJA and greater change in the GJA diameter correlated with greater weight loss in APMC-TORe and numerical trends in ft-TORe. CONCLUSIONS: This meta-analysis demonstrates that both ft-TORe and APMC-TORe offer significant and comparable weight-loss outcomes with a high and comparable safety profile. However, APMC-TORe typically required multiple endoscopic sessions. Identifying a goal for the final and change in GJA diameter could be useful treatment targets.

Cholangioscopy Biopsies Improve Detection of Cholangiocarcinoma When Combined with Cytology and FISH, but Not in Patients with PSC.

BACKGROUND AND AIMS: Single-operator cholangioscopy (SOC) has been suggested to be a cost-effective strategy for the detection of cholangiocarcinoma (CCA). The aim of this study is to compare the performance characteristics of SOC-guided biopsies and transpapillary biopsies with standard sampling techniques for the detection of CCA. METHODS: A retrospective cohort study of patients undergoing SOC between 1/2007 and 10/2018 at a single academic center was performed. Demographic, procedural, and outcomes data were recorded and analyzed using STATA 14.0. Sensitivity comparison between diagnostic tests was performed using exact McNemar test exclusively among patients with CCA. Two-sided p value < 0.05 was considered statistically significant. RESULTS: Ninety-two patients were included; 36 (39.1%) with primary sclerosing cholangitis (PSC), 41 (44.6%) with CCA, and median follow-up was 15.1 months. In the overall cohort, brush cytology demonstrated a sensitivity of 44.7% and increased with the addition of FISH (56.8%; p = 0.12), FISH with SOC-guided biopsy (71.4%; p = 0.03), and FISH with transpapillary biopsy (64.5%; p = 0.01). However, in patients with PSC, there was no significant improvement in sensitivity with the addition of SOC-guided biopsy or transpapillary biopsy in addition to FISH when compared to brush cytology. There was no difference in the rates of overall adverse events (14% vs. 23.2%; p = 0.27) or infection (3% vs. 4%; p = 0.83) in patients with and without PSC. CONCLUSIONS: SOC-guided and transpapillary biopsies improve sensitivity for the detection of cholangiocarcinoma in combination with other ERCP-based techniques compared to brush cytology alone. However, while safe, these modalities do not significantly improve the sensitivity for the detection of malignancy in PSC patients.

An innovative technique using a percutaneously placed guidewire allows for higher success rate for ERCP compared to balloon enteroscopy assistance in Roux-en-Y gastric bypass anatomy.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is technically challenging in Roux-en-Y gastric bypass (RYGB). Current approaches either have high failure rate, are resource intensive, or invasive. OBJECTIVE: To describe successful adoption of an old technique for performance of ERCP in patients with RYGB anatomy employing enteroscopy with the assistance of a percutaneously placed guidewire, which facilitates both reaching and cannulating the major papilla. METHOD: A retrospective cohort study in a tertiary-care center. We included patients with RYGB from 2015 to 2017 who underwent ERCP. We compared success rate and adverse events between rendezvous guidewire-assisted (RGA) and balloon-assisted enteroscopy (BAE) ERCP techniques. RESULTS: Thirty patients with RYGB underwent 62 ERCPs. The mean age was 62.2 ± 11 years with female predominance 83.3%. The procedures were performed using BAE 43/62 (69.3%), RGA 13/62 (21%), gastrostomy tube 5/62 (8.1%), and colonoscope 1/62 (1.6%). In patients with a native papilla (n = 37 ERCPs), clinical success rate with BAE was 36.8% compared to 100% with RGA (P < 0.001). There was no significant difference in bleeding (P = 0.17), post-ERCP pancreatitis (P = 0.4), or luminal perforation (P = not estimated) between the two techniques in native papilla. The mean procedure time with the RGA was significantly shorter than successful BAE with mean difference: 33 min (95% CI 8-57 min, P = 0.01). Twenty-five ERCPs were performed in eight patients with non-native papilla. BAE success rate in non-native papilla was 95.8%. The mean procedure time of the BAE in non-native papilla was 111 ± 60 min. Native papillae were associated with a significantly higher BAE failure rate compared to non-native papillae (OR: 12; 95% CI 1.44-99.7, P = 0.02). CONCLUSION: In patients with RYGB, RGA appears to be highly successful and safe in achieving clinical success for patients with native papilla as compared to BAE.

Surgical outcomes of ERCP-guided transpapillary gallbladder drainage versus percutaneous cholecystostomy as bridging therapies for acute cholecystitis followed by interval cholecystectomy.

BACKGROUND: Select patients with acute cholecystitis (AC) are not candidates for index cholecystectomy. We compared the influence of ERCP-guided transpapillary gallbladder drainage (ERGD) versus percutaneous cholecystostomy (PC) on delayed cholecystectomy outcomes. METHODS: Consecutive patients undergoing ERGD or PC for AC from January 2007 to October 2018 were included. Primary outcome was the rate of conversion to open cholecystectomy and perioperative complications in groups. RESULTS: The study included 52 patients with ERGD and 140 with PC prior to cholecystectomy (median 68 days [IQR: 47-105.5]). Technical success was higher in the PC group (100% vs 91%; P = 0.0004). There was a nonsignificant trend to lower postoperative complications with ERGD (30.7% vs 43.5%; P = 0.07). No difference in conversion to open cholecystectomy OR: 1.5 (95% CI: 0.68-3.65; P = 0.28) or severity of complications (Clavien-Dindo grade >2) OR: 0.60, (95% CI: 0.19-1.87; P = 0.38) was noted between the ERGD and PC groups. PC was associated with higher rates of unplanned repeat intervention (16.4% vs 7.7%; P = 0.02). CONCLUSION: ERGD is suitable for patients with AC who is candidates for delayed cholecystectomy and should be considered for gallbladder drainage in patients with concomitant choledocholithiasis or cholangitis who require ERCP.

Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial.

OBJECTIVES: The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling. METHODS: In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m2 were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m2) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m2). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% excess weight loss. RESULTS: At 52 weeks, participants in the AspireAssist group, on a modified intent-to-treat basis, had lost a mean (±s.d.) of 31.5±26.7% of their excess body weight (12.1±9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5% of their excess body weight (3.5±6.0% total body weight) (P<0.001). A total of 58.6% of participants in the AspireAssist group and 15.3% of participants in the Lifestyle Counseling group lost at least 25% of their excess body weight (P<0.001). The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the AspireAssist group. CONCLUSIONS: The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.