Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial.

BACKGROUND: The combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention. METHODS: In this randomised, non-inferiority trial conducted at 20 referral centres in the USA and Canada, patients (aged ≥18 years) at high risk for post-ERCP pancreatitis were randomly assigned (1:1) to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent. Patients, treating clinicians, and outcomes assessors were masked to study group assignment. The primary outcome was post-ERCP pancreatitis. To declare non-inferiority, the upper bound of the two-sided 95% CI for the difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) would have to be less than 5% (non-inferiority margin) in both the intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov (NCT02476279), and is complete. FINDINGS: Between Sept 17, 2015, and Jan 25, 2023, a total of 1950 patients were randomly assigned. Post-ERCP pancreatitis occurred in 145 (14·9%) of 975 patients in the indomethacin alone group and in 110 (11·3%) of 975 in the indomethacin plus stent group (risk difference 3·6%; 95% CI 0·6-6·6; p=0·18 for non-inferiority). A post-hoc intention-to-treat analysis of the risk difference between groups showed that indomethacin alone was inferior to the combination of indomethacin plus prophylactic stent (p=0·011). The relative benefit of stent placement was generally consistent across study subgroups but appeared more prominent among patients at highest risk for pancreatitis. Safety outcomes (serious adverse events, intensive care unit admission, and hospital length of stay) did not differ between groups. INTERPRETATION: For preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines. FUNDING: US National Institutes of Health.

Rise in First-Time ERCP For Benign Indications >1 Year After Cholecystectomy Is Associated With Worse Outcomes.

BACKGROUND & AIMS: Greater availability of less invasive biliary imaging to rule out choledocholithiasis should reduce the need for diagnostic endoscopic retrograde cholangiopancreatography (ERCP) in patients who have a remote history of cholecystectomy. The primary aims were to determine the incidence, characteristics, and outcomes of individuals who undergo first-time ERCP >1 year after cholecystectomy (late-ERCP). METHODS: Data from a commercial insurance claim database (Optum Clinformatics) identified 583,712 adults who underwent cholecystectomy, 4274 of whom underwent late-ERCP, defined as first-time ERCP for nonmalignant indications >1 year after cholecystectomy. Outcomes were exposure and temporal trends in late-ERCP, biliary imaging utilization, and post-ERCP outcomes. Multivariable logistic regression was used to examine patient characteristics associated with undergoing late-ERCP. RESULTS: Despite a temporal increase in the use of noninvasive biliary imaging (35.9% in 2004 to 65.6% in 2021; P < .001), the rate of late-ERCP increased 8-fold (0.5-4.2/1000 person-years from 2005 to 2021; P < .001). Although only 44% of patients who underwent late-ERCP had gallstone removal, there were high rates of post-ERCP pancreatitis (7.1%), hospitalization (13.1%), and new chronic opioid use (9.7%). Factors associated with late-ERCP included concomitant disorder of gut-brain interaction (odds ratio [OR], 6.48; 95% confidence interval [CI], 5.88-6.91) and metabolic dysfunction steatotic liver disease (OR, 3.27; 95% CI, 2.79-3.55) along with use of anxiolytic (OR, 3.45; 95% CI, 3.19-3.58), antispasmodic (OR, 1.60; 95% CI, 1.53-1.72), and chronic opioids (OR, 6.24; 95% CI, 5.79-6.52). CONCLUSIONS: The rate of late-ERCP postcholecystectomy is increasing significantly, particularly in patients with comorbidities associated with disorder of gut-brain interaction and mimickers of choledocholithiasis. Late-ERCPs are associated with disproportionately higher rates of adverse events, including initiation of chronic opioid use.

Treatment of walled-off necrosis using lumen-apposing metal stents versus plastic stents: a systematic review and meta-analysis of data from randomized trials.

BACKGROUND: Walled-off necrosis (WON) is highly morbid disease most effectively managed by endoscopic drainage with lumen-apposing metal stents (LAMSs) or plastic stents, with or without necrosectomy. This meta-analysis compared the clinical outcomes of patients included in randomized trials treated using LAMSs or plastic stents. METHODS: The MEDLINE and EMBASE databases were searched to identify all data collected from randomized trials comparing LAMSs and plastic stents for the treatment of WON. The primary outcome measure was need for endoscopic necrosectomy. RESULTS: Three studies comprising 206 patients met inclusion criteria. Except for procedure duration, which was significantly shorter for LAMSs (standardized mean difference [SMD] -1.22, 95%CI -1.64 to -0.79), there was no significant difference in need for necrosectomy (38.5% vs. 41.2%; risk ratio [RR] 1.07, 95%CI 0.79-1.45), number of interventions (SMD -0.09, 95%CI -0.40 to 0.22), treatment success (90.7% vs. 94.5%; RR 0.96, 95%CI 0.87-1.06), recurrence (4.6% vs. 0.6%; RR 3.73, 95%CI 0.42-33.0), readmission (42.6% vs. 50.2%; RR 0.84, 95%CI 0.62-1.14), length of hospitalization (SMD -0.06, 95%CI -0.55 to 0.43), mortality (8.5% vs. 9.8%; RR 0.70, 95%CI 0.30-1.66), new-onset organ failure (10.6% vs. 14.6%; RR 0.72, 95%CI 0.16-3.32), bleeding (11.0% vs. 10.7%; RR 1.09, 95%CI 0.34-3.44), procedural adverse events (23.6% vs. 19.2%; RR 1.38, 95%CI 0.82-2.33), or overall costs (SMD -0.04, 95%CI -0.31 to 0.24) between LAMSs and plastic stents, respectively. CONCLUSIONS: Except for procedure duration, there is no significant difference in clinical outcomes for patients with WON treated using LAMSs or plastic stents.

Impact of endoprosthesis type on inflammatory response in patients undergoing endoscopic drainage of pancreatic fluid collections.

OBJECTIVE: To study the impact of endoprosthesis type on inflammatory response in patients undergoing endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFC). METHODS: Patients undergoing EUS-guided PFC drainage and treated using lumen-apposing metal stents (LAMS) or plastic endoprostheses constituted the study cohort. The primary outcome was the presence of systemic inflammatory response syndrome (SIRS) after index intervention. Secondary outcomes were persistent organ failure, new onset organ failure, duration of hospitalization, and treatment success. RESULTS: In all, 303 patients were treated using LAMS (n = 247) or plastic stents (n = 56). At 48 h postintervention, the presence of SIRS (25.0 vs. 14.2%, P = 0.047), new onset SIRS (10.0 vs. 1.8%, P = 0.017), and new organ failure (5.4 vs. 0.4%, P = 0.003) were significantly higher in the plastic stent cohort compared to LAMS. On multivariable logistic regression analysis, the use of plastic stents (odds ratio [OR] 2.7, 95% confidence interval [CI] 1.2-6.0, P = 0.014), patients receiving high-acuity care (OR 5.1, 95% CI 2.5-10.4, P < 0.001) and the presence of ≥33% of necrosis (OR 4.5, 95% CI 2.0-10.0, P < 0.001) were significantly associated with the presence of SIRS or new organ failure. While there was no significant difference in treatment success (96.4 vs. 95.5%, P = 0.77), duration of hospitalization was significantly longer for the plastic stent cohort (mean [standard deviation] 12.5 [17.8] vs. 7.9 [10.1] days, P = 0.009). CONCLUSIONS: Use of plastic stents as compared to LAMS was associated with a higher proportion of SIRS and new organ failure that prolonged hospital stay. Therefore, placement of LAMS is recommended in sick patients and those with ≥33% necrosis to minimize inflammatory response.

Impact of Slim Linear Echoendoscope on the Practice of EUS.

BACKGROUND: Standard linear echoendoscopes have a large distal tip and bending radius, which can preclude adequate examination in some patients. OBJECTIVE: We examined the impact of having available slim linear echoendoscopes (SLE) on our endoscopic ultrasound (EUS) practice. MATERIALS AND METHODS: As a quality improvement measure, data on the need for the use of SLE were documented in 2000 consecutive procedures performed over a 10-month period from February to November 2022. When examination using a standard size echoendoscope failed due to technical limitations, the procedure was reattempted in the same session using a SLE. The main outcome was the impact of SLE, which was defined as the establishment of a new diagnosis or if findings altered treatment plan. RESULTS: A complete EUS examination failed in 23 of 2000 procedures (1.15%, 95% CI, 0.73-1.72%) performed using standard size echoendoscope (14 male, median age 73 y [IQR 66 to 79]). The examination was technically successful when using SLE in 22 of 23 (95.6%) patients. SLE impacted clinical management in all 22 patients (100%) by establishing tissue diagnosis in 19 and/or altering subsequent treatment plan in 5. Adverse event of transient hypoxia was observed in one patient (4.3%). CONCLUSIONS: A very experienced EUS team required SLE in 1.1% of consecutive examinations. Our findings suggest that when used, 95% of patients benefitted as it had a significant impact on their clinical management.

Orlando Protocol for single session ductal clearance of common bile duct stones at endosopic retrograde cholangiopancreatography.

OBJECTIVES: Approach to management of common bile duct stones (CBDS) by endoscopic retrograde cholangiopancreatography (ERCP) is not standardized. We examined outcomes by applying predetermined protocol for CBDS management. METHODS: When standard extraction techniques failed at ERCP, presence of tapered bile duct and stone-duct ratio were calculated. Large balloon sphincteroplasty (LBS) and/or mechanical/single-operator cholangioscopy-guided lithotripsy was performed based on presence of tapered bile duct and stone-duct mismatch. Primary outcome was single-session ductal clearance. Secondary outcome was adverse events. RESULTS: Of 409 patients treated over 16 months, 321 (78.5%) had no tapered bile duct or stone-duct mismatch, and single-session ductal clearance was achieved using standard techniques in 99.7% over median duration of 14 min (interquartile range [IQR] 9-21 min). Of 88 (21.5%) patients with difficult CBDS, tapered duct was seen in 79 (89.8%) and/or stone-duct mismatch in 36 (40.9%). Single-session ductal clearance was achieved in all 88 patients (100%) by LBS in 79 (89.8%), mechanical lithotripsy in 20 (22.7%), and single-operator cholangioscopy-guided lithotripsy in 16 (18.2%) over a median duration of 29 min (IQR 17-47 min). Overall, single-session ductal clearance was achieved in 99.8% with adverse events in 17 (4.2%) that included perforation in two, postsphincterotomy bleeding in one, and mild/moderate post-ERCP pancreatitis in 14 patients. CONCLUSIONS: A predetermined protocol optimized outcomes by enabling single-session ductal clearance of CBDS with high technical success and low adverse events.

Characteristics of Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Sphincter of Oddi Disorders.

The concept that sphincter of Oddi dysfunction (SOD) can cause attacks of biliary-type pain in postcholecystectomy patients and those with unexplained recurrent acute pancreatitis, and that endoscopic sphincterotomy can ameliorate symptoms, remains unproven. The Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD) study of patients without objective evidence for biliary obstruction showed no difference in outcomes between those who underwent sphincterotomy or sham treatment.1 To date, there have been no studies examining the characteristics of patients who still are being offered endoscopic retrograde cholangiopancreatography (ERCP) for SOD since the EPISOD publication, although the absolute number appears to have declined.2.

Endoscopic biliary drainage for malignant distal biliary obstruction: Which is better - endoscopic retrograde cholangiopancreatography or endoscopic ultrasound?

Presently, following endoscopic ultrasound (EUS)-guided biopsy, an endoscopic retrograde cholangiopancreatography (ERCP) with transpapillary stenting is performed for palliation of malignant distal biliary obstruction (MDBO). However, technical failure and postprocedure pancreatitis are limitations to ERCP. Endoscopic ultrasonography-guided biliary drainage (EUS-BD) after a failed ERCP has a 90% technical success rate and has been shown to be superior when compared to percutaneous methods, making EUS an increasingly recognized option for biliary drainage. Supporting this approach, findings from recently concluded randomized trials suggest that the safety profile and technical outcomes for EUS-BD are comparable or even superior to that of ERCP for primary biliary decompression in patients with MDBO. Also, EUS-BD is increasingly being utilized in patients with altered surgical anatomy in lieu of percutaneous techniques and balloon-assisted enteroscopy. A growing body of evidence supports the notion that, in the future, EUS may become the primary modality by which biliary decompression is undertaken in the majority of patients with MDBO. The roadmap to this eventuality may require further optimization of procedural techniques, technological innovations, and cost reduction.

Validation of the Orlando Protocol for endoscopic management of pancreatic fluid collections in the era of lumen-apposing metal stents.

OBJECTIVES: Although lumen-apposing metal stents (LAMS) are being increasingly used in lieu of plastic stents, the clinical approach to endoscopic management of pancreatic fluid collections (PFCs) is poorly standardized. We compared outcomes of approaches over two time intervals, initially using plastic stents and later integrating LAMS. METHODS: This was a retrospective, observational, before-after study of prospectively collected data on consecutive patients with symptomatic PFCs managed over two time periods. In the initial period (January 2010-January 2015) endoscopic treatment was undertaken with plastic stents and in the later period (February 2015-August 2020) by integration of LAMS with selective use of plastic stents. The treatment strategy in both periods were tailored to size, extent, type of PFC and stepwise response to intervention. The main outcome was treatment success, defined as resolution of PFC and presenting symptoms at 6-month follow-up. RESULTS: A total of 160 patients were treated with plastic stents and 227 patients were treated using an integrated LAMS approach. Treatment success was significantly higher for the integrated approach compared to using only plastic stents (95.6 vs. 89.4%; P = 0.018), which was confirmed to be predictive of treatment success on multivariable logistic regression analysis (odds ratio 2.7, 95% confidence interval 1.1-6.4; P = 0.028). CONCLUSIONS: A structured approach integrating LAMS with selective use of plastic stents improved treatment success in patients with PFCs compared to an approach using only plastic stents.

Equivalent performance of single-use and reusable duodenoscopes in a randomised trial.

OBJECTIVE: Single-use duodenoscopes have been recently developed to eliminate risk of infection transmission from contaminated reusable duodenoscopes. We compared performances of single-use and reusable duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). DESIGN: Patients with native papilla requiring ERCP were randomised to single-use or reusable duodenoscope. Primary outcome was comparing number of attempts to achieve successful cannulation of desired duct. Secondary outcomes were technical performance that measured duodenoscope manoeuvrability, mechanical-imaging characteristics and ability to perform therapeutic interventions, need for advanced cannulation techniques or cross-over to alternate duodenoscope group to achieve ductal access and adverse events. RESULTS: 98 patients were treated using single-use (n=48) or reusable (n=50) duodenoscopes with >80% graded as low-complexity procedures. While median number of attempts to achieve successful cannulation was significantly lower for single-use cohort (2 vs 5, p=0.013), ease of passage into stomach (p=0.047), image quality (p<0.001), image stability (p<0.001) and air-water button functionality (p<0.001) were significantly worse. There was no significant difference in rate of cannulation, adverse events including mortality (one patient in each group), need to cross-over or need for advanced cannulation techniques to achieve ductal access, between cohorts. On multivariate logistic regression analysis, only duodenoscope type (single-use) was associated with less than six attempts to achieve selective cannulation (p=0.012), when adjusted for patient demographics, procedural complexity and type of intervention. CONCLUSION: Given the overall safety profile and similar technical performance, single-use duodenoscopes represent an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov number: NCT04143698.

Importance of Disconnected Pancreatic Duct Syndrome in Recurrence of Pancreatic Fluid Collections Initially Drained Using Lumen-Apposing Metal Stents.

BACKGROUND & AIMS: Indwelling plastic endoprosthesis in patients with disconnected pancreatic duct syndrome (DPDS) reduces the risk of pancreatic fluid collection (PFC) recurrence. Although lumen-apposing metal stents (LAMS) are used with increasing frequency for PFC drainage, they require timely removal and little is known about their effects in patients with DPDS and recurrence of PFC. METHODS: We performed a prospective study of patients who underwent endoscopic ultrasound-guided drainage of PFC using LAMS and were found to have DPDS. After resolution of PFC, LAMS were replaced with double-pigtail plastic stents. The primary outcome was to compare PFC recurrence between patients with DPDS who did vs did not receive replacements with plastic stents after removal of the LAMS. RESULTS: Of 188 PFC patients treated with LAMS, 94 had DPDS, 71 had intact pancreatic ducts, and duct patency was unknown in 23. In patients with DPDS, replacement of LAMS with plastic stents was successful in 70 patients (74.5%) and technically unsuccessful in 24 patients (25.5%). At a median follow up of 183 days (interquartile range, 179-188 days), although none of the patients with an intact duct had a recurrence of PFC, 7 of the 94 patients with DPDS had recurrence of PFC (7.4%) (P = .020). PFC recurred in 1 of 70 patients with DPDS in whom replacement of LAMS with plastic stent was successful (1.4%) and in 6 of 24 patients with unsuccessful stent replacement (25.0%) (P = .001). CONCLUSIONS: In treatment of PFCs with LAMS in patients with DPDS, it is important to replace the LAMS with indwelling plastic stents to minimize PFC recurrence and reduce morbidity. Clinicaltrials.gov no: NCT02422095.

Comparing Needles and Methods of Endoscopic Ultrasound-Guided Fine-Needle Biopsy to Optimize Specimen Quality and Diagnostic Accuracy for Patients With Pancreatic Masses in a Randomized Trial.

BACKGROUND & AIMS: Given the lack of procedure standardization, findings vary from analyses of pancreatic tissues collected by endoscopic ultrasound-guided fine-needle biopsy. It is not clear which needle and technique yield the best specimen for analysis. We compared the specimen quality and accuracy of diagnoses made from samples collected by fine-needle biopsy needles using different collection techniques. METHODS: Patients found to have pancreatic masses during imaging (n = 129) were assigned randomly to groups from whom pancreatic tissue samples were collected by reverse-bevel, Menghini-tip, franseen, or fork-tip needles. A second randomization determined the technical sequence of biopsies in each patient (suction, no suction, and stylet retraction). Two independent pathologists, blinded to the type of needle and sampling technique, analyzed all the samples. Final diagnoses of malignancy were made based on surgical resection, death from cancer progression, or findings from radiology or clinical follow-up evaluations (reference standard). The primary objective was to compare the cellularity of the samples collected, defined as the proportion of core tissue in the biopsy sample. Secondary objectives were to compare the accuracy of diagnoses made from biopsy samples and identify factors associated with high cellularity. RESULTS: One-hundred and nine patients had a final diagnosis of malignancy (84.5%) and 20 patients had benign disease (15.5%). Samples collected by fork-tip or franseen needles had significantly higher cellularity than samples collected by reverse-bevels or Menghini-tip needles (P < .001). Neoplasias were identified with greater than 90% accuracy using samples collected by fork-tip or franseen needles (P < .001 compared with other needles). On multivariable regression analysis, use of franseen needles (odds ratio [OR], 4.42; 95% CI, 2.58-7.58; P < .001) or fork-tip needles (OR, 3.86; 95% CI, 2.24-6.64; P < .001), stylet retraction (OR, 2.13; 95% CI, 1.21-3.72; P = .008), no suction (OR, 2.74; 95% CI, 1.57-4.80; P < .001), and pancreatic mass larger than 3 cm (OR, 1.92; 95% CI, 1.21-3.05; P = .005) were associated with high cellularity of the sample. CONCLUSIONS: In patients with suspected pancreatic cancer, samples with the highest degree of cellularity in a single biopsy, resulting in a diagnostic accuracy of 90% of higher, were collected by fine-needle biopsy using the franseen or fork-tip needle. Clinicaltrials.gov no: NCT04085055.

Single-use duodenoscopes: where are we and where are we going?

PURPOSE OF REVIEW: Given the growing concerns about infection transmission from use of contaminated reusable duodenoscopes, technological advancements have been made that vary from modifications of existing designs to development of single-use devices. RECENT FINDINGS: To circumvent mechanical limitations that preclude access to critical areas of a duodenoscope to perform thorough cleaning and disinfection, single-use disposable duodenoscopes have been developed. A thorough assessment of this technology is limited by the minimal published data that is currently available. This opinion assesses the current technical functionality of these devices, potential for further improvements, implications for healthcare economics and the future of gastrointestinal endoscopy. SUMMARY: Currently available data suggest that majority of endoscopic retrograde cholangiopancreatography procedures can be safely performed using single-use duodenoscopes. The ability to improve technical functionality, incorporate futuristic technology and secure financial reimbursement from insurance carriers will largely define the future prospects of this recent innovation.

Development and initial validation of an instrument for video-based assessment of technical skill in ERCP.

BACKGROUND AND AIMS: The accurate measurement of technical skill in ERCP is essential for endoscopic training, quality assurance, and coaching of this procedure. Hypothesizing that technical skill can be measured by analysis of ERCP videos, we aimed to develop and validate a video-based ERCP skill assessment tool. METHODS: Based on review of procedural videos, the task of ERCP was deconstructed into its basic components by an expert panel that developed an initial version of the Bethesda ERCP Skill Assessment Tool (BESAT). Subsequently, 2 modified Delphi panels and 3 validation exercises were conducted with the goal of iteratively refining the tool. Fully crossed generalizability studies investigated the contributions of assessors, ERCP performance, and technical elements to reliability. RESULTS: Twenty-nine technical elements were initially generated from task deconstruction. Ultimately, after iterative refinement, the tool comprised 6 technical elements and 11 subelements. The developmental process achieved consistent improvements in the performance characteristics of the tool with every iteration. For the most recent version of the tool, BESAT-v4, the generalizability coefficient (a reliability index) was .67. Most variance in BESAT scores (43.55%) was attributed to differences in endoscopists' skill, indicating that the tool can reliably differentiate between endoscopists based on video analysis. CONCLUSIONS: Video-based assessment of ERCP skill appears to be feasible with a novel instrument that demonstrates favorable validity evidence. Future steps include determining whether the tool can discriminate between endoscopists of varying experience levels and predict important outcomes in clinical practice.

Outcomes of a Structured, Stepwise Approach to Endoscopic Necrosectomy.

BACKGROUND AND AIM: Despite the increasing number of procedures being performed, there is no consensus on the optimal approach to performing direct endoscopic necrosectomy (DEN), which is a labor-intensive, nonstandardized intervention. We prospectively validated the usefulness of a predefined, structured, stepwise approach to DEN with the objective of improving procedural efficiency and resource use. MATERIALS AND METHODS: A prospective study of patients with necrotizing pancreatitis who after endoscopic transluminal drainage did not have clinical improvement and required DEN. The study was undertaken in 2 phases. Phase I was a retrospective analysis of interventions performed using an unstructured, conventional approach. Median of 3 necrosectomy sessions (range, 2 to 3) were required to achieve 80% treatment success in 20 patients. On the basis of these observations, a structured approach that included 3 steps (debridement, necrosis extraction, and irrigation) was developed and validated prospectively in phase II in 39 patients. The main outcome was to compare procedural efficiency defined as a number of necrosectomy sessions to achieve treatment success. RESULTS: Although there was no significant difference in treatment success (phase I=80.0 vs. phase II=94.9%, P=0.17), the procedure was more efficient in phase II [median session, 2 (interquartile range=1 to 3) vs. 3 (interquartile range=2 to 3); P=0.003]. Multiple logistic regression analysis revealed that a structured, stepwise approach was associated with fewer necrosectomy sessions to achieve treatment success (odds ratio=4.7; 95% confidence interval=1.5-15.0; P=0.008) when adjusted for patient demographics, lab parameters, and disease characteristics. CONCLUSIONS: By decreasing the number of necrosectomy sessions, a structured, stepwise approach to endoscopic necrosectomy seems to improve procedural efficiency.

Endoscopic Mucosal Resection for Colonic Mucosal Neoplasia and Evaluation of Long-Term Recurrence: A Single-Center Experience of 500 Cases.

OBJECTIVES: Endoscopic mucosal resection (EMR) is an alternative to surgery for the treatment of large laterally spreading lesions. Residual or recurrent adenoma is a major limitation. This study aimed to quantify early and late recurrences and to assess its associated risk factors. METHODS: The study was a single-center, multiendoscopist, longitudinal study conducted between January 1, 2013 and April 26, 2017. A total of 480 patients with 500 polyps who underwent an endoscopic resection were included. Surveillance colonoscopy (SC) was performed at 4 to 6 months (SC1) and 16 to 18 months (SC2). RESULTS: At SC1, early recurrence was noted in 77 of 354 (21.8%) lesions; 76 (98.7%) were treated endoscopically. The remaining 277 of 354 (78.2%) lesions had no recurrence at SC1; only 41 lesions (15%) were followed up at SC2. Recurrence at SC2 was found in 4 lesions (9.8%), all of which were treated endoscopically. Lesion size >40 mm was associated with recurrence. Recurrence at both SC1 and SC2 was successfully treated endoscopically in 78 of 81 lesions (96.3%). CONCLUSIONS: EMR is an effective, minimally invasive technique for the treatment of large laterally spreading lesions. Although recurrence is a concern, its risk is low (21.8% on SC1 and 9.8% on SC2) and was managed endoscopically in 96.3% cases on follow-up endoscopy.

Prospective evaluation of an assessment tool for technical performance of duodenoscopes.

OBJECTIVE: While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes. METHODS: An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6-month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach's coefficient alpha (α). The secondary outcome was validity of the assessment tool. RESULTS: The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach's coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores. CONCLUSIONS: The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533.

Efficacy of Single-Operator Cholangioscopy-Guided Lithotripsy Compared With Large Balloon Sphincteroplasty in Management of Difficult Bile Duct Stones in a Randomized Trial.

BACKGROUND & AIMS: Although single-operator cholangioscopy (SOC)-guided lithotripsy and large balloon sphincteroplasty (LBS)-based techniques are effective rescue measures, the ideal approach to management of difficult bile duct stones is unclear. We conducted a randomized trial to compare the effectiveness of SOC-guided lithotripsy and LBS-based approaches for endoscopic management of difficult bile duct stones. METHODS: Patients with difficult bile duct stones who failed retrieval using balloon or basket were randomly assigned to groups that received SOC-guided laser lithotripsy (SOC-LL, n = 33) or LBS (n = 33), from June 2016 through August 2018. When assigned treatment was unsuccessful, patients underwent mechanical lithotripsy before crossing over to the other group. The main outcome was treatment success, defined as ability to clear the duct in 1 session. Secondary outcomes were adverse events and treatment costs. RESULTS: A higher proportion of patients in the SOC-LL group had treatment success (93.9%) than in the LBS group (72.7%; P = .021). On multiple logistic regression analysis, treatment success was significantly associated with use of SOC-LL (odds ratio [OR], 8.7; 95% CI, 1.3-59.3; P = .026), stone to extrahepatic bile duct ratio of 1 or less (OR, 28.8; 95% CI, 1.2-687.6; P = .038), and lack of a tapered bile duct (OR, 26.9; 95% CI, 1.3-558.2; P = .034). There was no significant difference between groups in adverse events (9.1% in the SOC-LL group vs 3.0% in the LBS group, P = .61) or overall treatment cost ($16,684 in the SOC-LL group vs $10,626 in the LBS group; P = .097). CONCLUSIONS: In a randomized trial of patients with difficult bile stones that cannot be cleared by standard maneuvers, SOC-guided lithotripsy leads to duct clearance in a significantly higher proportion of patients than LBS-particularly when stone size exceeds the diameter of the extrahepatic bile duct. Adjunct lithotripsy might be required in patients with tapered distal bile duct, because LBS alone is less likely to be successful. ClinicalTrials.gov no: NCT00852072.

Optimizing Outcomes of Single-Operator Cholangioscopy-Guided Biopsies Based on a Randomized Trial.

BACKGROUND & AIMS: Although single-operator cholangioscopy is considered to be the most sensitive method for tissue acquisition in patients with indeterminate bile duct strictures (IBDS), methods are needed to optimize the specimen collection and processing techniques. We aimed to determine the optimal method for specimen processing and identify the number of biopsies required to establish a definitive diagnosis. METHODS: Patients with IBDS were randomly assigned to groups that underwent specimen processing using the onsite (n = 32) or offsite (n = 30) method. The primary outcome was to compare operating characteristics of onsite vs offsite specimen processing techniques. The secondary outcome was number of biopsies needed to establish definitive diagnosis. A final diagnosis was established at surgery or after a minimum clinical follow-up period of 18 months RESULTS: The final diagnosis was benign disease in 33 patients and malignancy in 29 patients. There were no significant differences between the offsite and onsite groups in diagnostic accuracy (90% vs 87.5%; P=.99), sensitivity (76.9% vs 75%; P=.99), specificity (100% vs 100%; P=.99), positive predictive value (100% vs 100%; P=.99), or negative predictive value (85% vs 80%; P=.99). Although diagnoses were established by analysis of a median of 1 biopsy in the onsite cohort (interquartile range, 1-1.5), the diagnostic accuracy was identical (90%) in each group, regardless of whether 3 or 4 biopsies were collected from each patient in the offsite cohort. CONCLUSIONS: In a prospective comparative study, we found that centers without onsite cytopathology support that analyze 3 single-operator cholangioscopy-guided biopsies of a biliary stricture and process the specimens offsite make the correct diagnosis for 90% of cases. ClinicalTrials.gov, Number: NCT01815619.

An Endoscopic Transluminal Approach, Compared With Minimally Invasive Surgery, Reduces Complications and Costs for Patients With Necrotizing Pancreatitis.

BACKGROUND & AIMS: Infected necrotizing pancreatitis is a highly morbid disease with poor outcomes. Intervention strategies have progressed from open necrosectomy to minimally invasive approaches. We compared outcomes of minimally invasive surgery vs endoscopic approaches for patients with infected necrotizing pancreatitis. METHODS: We performed a single-center, randomized trial of 66 patients with confirmed or suspected infected necrotizing pancreatitis who required intervention from May 12, 2014, through March 24, 2017. Patients were randomly assigned to groups that received minimally invasive surgery (laparoscopic or video-assisted retroperitoneal debridement, depending on location of collection, n = 32) or an endoscopic step-up approach (transluminal drainage with or without necrosectomy, n = 34). The primary endpoint was a composite of major complications (new-onset multiple organ failure, new-onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, bleeding and perforation of a visceral organ) or death during 6 months of follow-up. RESULTS: The primary endpoint occurred in 11.8% of patients who received the endoscopic procedure and 40.6% of patients who received the minimally invasive surgery (risk ratio 0.29; 95% confidence interval 0.11-0.80; P = .007). Although there was no significant difference in mortality (endoscopy 8.8% vs surgery 6.3%; P = .999), none of the patients assigned to the endoscopic approach developed enteral or pancreatic-cutaneous fistulae compared with 28.1% of the patients who underwent surgery (P = .001). The mean number of major complications per patient was significantly higher in the surgery group (0.69 ± 1.03) compared with the endoscopy group (0.15 ± 0.44) (P = .007). The physical health scores for quality of life at 3 months was better with the endoscopic approach (P = .039) and mean total cost was lower ($75,830) compared with $117,492 for surgery (P = .039). CONCLUSIONS: In a randomized trial of 66 patients, an endoscopic transluminal approach for infected necrotizing pancreatitis, compared with minimally invasive surgery, significantly reduced major complications, lowered costs, and increased quality of life. Clinicaltrials.gov no: NCT02084537.