Standard Endoscopic Retrograde Cholangiopancreatography Research Articles

Adverse events of the single-operator cholangioscopy system: a Manufacturer and User Facility Device Experience database analysis

SpyGlass single operator cholangioscopy (SOC) system is generally considered safe but adds additional risks to those associated with standard endoscopic retrograde cholangiopancreatography. We evaluated adverse events (AEs) with the SpyGlass System reported in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2016 & August 2023. A total of 2331 device problems (SpyGlass DS:1301, SpyGlass DS II:1010) were reported. An optical problem was the most reported issue with 83 for the SpyGlass DS and 457 for the SpyGlass DS II. Patient related events were found in 62 (3.5%) of 1743 reports: 33 with SpyGlass DS, and 29 with SpyGlass DSII. The most common AEs were bleeding/hemorrhage followed by perforation, infection, fever, or sepsis and pancreatitis. Our findings add to the existing literature and provides a fuller picture of potential problems associated with SpyGlass™ SOC.

A Randomized Comparative Study of the Use of Individual Modality and Combination of Endoscopic Retrograde Cholangiopancreatography (ERCP) and Digital Single-Operator Cholangioscopy (DSOC) for Diagnosis of Indeterminate Biliary Strictures

Abstract Background: To determine the superiority of the combination of endoscopic retrograde cholangiopancreatography (ERCP) and digital single-operator cholangioscopy (DSOC) in the same sitting over the individual modality alone in patients with indeterminate biliary strictures. Materials and Methods: A randomized study enrolled 60 adult patients with biliary strictures who were randomized into two groups: ERCP + DSOC and ERCP/DSOC. Histopathologic or cytologic assessment was performed in terms of benign, indeterminate, or malignant nature of the strictures. Procedural adverse events were documented. Accuracy in terms of sensitivity (Sn), specificity (Sp), and predictive value [positive (PPV) and negative (NPV)] were noted. Results: As per final diagnosis, in ERCP/DSOC group, there were 12 (40%) benign cases and 18 (60%) malignant cases, and in group ERCP + DSOC, there were 8 (26.67%) benign cases and 22 (73.33%) malignant cases. ERCP/DSOC labeled 16 (53.33%) patients as benign, 8 (26.67%) as malignant, and 6 (20%) as indeterminate, while ERCP + DSOC labeled 8 (26.67%) as benign, 17 (56.67%) as malignant, and 5 (16.67%) as indeterminate. The Sn, Sp, PPV, and NPV of ERCP/DSOC were 44.4%, 75%, 100%, and 56.25%, and for ERCP + DSOC was 77.27%, 62.50%, 100%, and 62.5%, respectively (P = 0.033). Side effects were statistically similar in both the groups (P > 0.05). Conclusion: To conclude, the combination of ERCP with DSOC is safe and effective with higher diagnostic sensitivity (77.27%) in comparison to standard ERCP or DSOC alone (44.4%) for the diagnosis of biliary strictures.

Endoscopic ultrasound-rendezvous versus percutaneous-endoscopic rendezvous endoscopic retrograde cholangiopancreatography for bile duct access: Systematic review and meta-analysis.

Endoscopic ultrasound (EUS) or percutaneous-assisted antegrade guidewire insertion can be used to achieve biliary access when standard endoscopic retrograde cholangiopancreatography (ERCP) fails. We conducted a systematic review and meta-analysis to evaluate and compare the effectiveness and safety of EUS-assisted rendezvous (EUS-RV) and percutaneous rendezvous (PERC-RV) ERCP. We searched multiple databases from inception to September 2022 to identify studies reporting on EUS-RV and PERC-RV in failed ERCP. A random-effects model was used to summarize the pooled rates of technical success and adverse events with 95% confidence interval (CI). In total, 524 patients (19 studies) and 591 patients (12 studies) were managed by EUS-RV and PERC-RV, respectively. The pooled technical successes were 88.7% (95% CI 84.6-92.8%, I2 = 70.5%) for EUS-RV and 94.1% (95% CI 91.1-97.1%, I2 = 59.2%) for PERC-RV (P = 0.088). The technical success rates of EUS-RV and PERC-RV were comparable in subgroups of benign diseases (89.2% vs. 95.8%, P = 0.068), malignant diseases (90.3% vs. 95.5%, P = 0.193), and normal anatomy (90.7% vs. 95.9%, P = 0.240). However, patients with surgically altered anatomy had poorer technical success after EUS-RV than after PERC-RV (58.7% vs. 93.1%, P = 0.036). The pooled rates of overall adverse events were 9.8% for EUS-RV and 13.4% for PERC-RV (P = 0.686). Both EUS-RV and PERC-RV have exhibited high technical success rates. When standard ERCP fails, EUS-RV and PERC-RV are comparably effective rescue techniques if adequate expertise and facilities are feasible. However, in patients with surgically altered anatomy, PERC-RV might be the preferred choice over EUS-RV because of its higher technical success rate.

Endoscopic nasobiliary drainage-based saline-injection ultrasound: an imaging technique for remnant stone detection after retrograde cholangiopancreatography

BackgroundThe purpose of this retrospective study aimed to assess the accuracy of detection of remnant common bile duct (CBD) stones by injecting saline through endoscopic nasobiliary drainage (ENBD) tubes under transabdominal ultrasound (US) guidance.MethodStone extraction and ENBD are regularly achieved through endoscopic retrograde cholangiopancreatography (ERCP) in patients with CBD stones. At 1–3 days thereafter, routine US studies were performed and repeated, using ENBD tubal saline injections (20–100 mL).ResultsA total of 302 patients underwent standard ERCP stone extractions in conjunction with occlusion cholangiograms, routine US testing, and ENBD-based saline-injection US exams. By occlusion cholangiogram, remnant stones were suspected in 31 (10.3%) patients in total of 302, and 26 (83.8%) were verified as true positives (sensitivity, 50.9%; specificity, 98.0%). Routine US studies proved suspicious in 13 (4.3%) patients in total of 302, and 12 (92.3%) were verified as true positives (sensitivity, 23.5%; specificity, 99.6%). Using ENBD-based saline-injection US, suspected stones were identified in 50 (16.6%) patients in total of 302, and 46 (92%) were verified as true positives (sensitivity, 90.1%; specificity, 98.4%). The sensitivity of ENBD-based saline-injection US significantly surpassed that of occlusion cholangiogram (p < 0.001) and routine US (p < 0.001).ConclusionDetection of remnant CBD stones via ENBD-based saline-injection US is a valid, inexpensive, and repeatable means of patient screening that is non-invasive, radiation-free, and dynamically informative. This may help improve the accuracy of detecting remnant CBD stones after ERCP.

Gallbladder biliary lithotripsy: A new rationale applied to old treatment.

Pure endoscopic treatment of combined cholelithiasis and choledocholithiasis is possible due to the chance to use together both endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) approaches. This endotherapy permits to treat biliary stones in the main bile duct by standard ERCP and gallbladder stones by EUS-guided cholecystoduodenostomy eventually associated to intracorporeal lithotripsy to achieve optimal results.

Troubleshooting Difficult Bile Duct Access: Advanced ERCP Cannulation Techniques, Percutaneous Biliary Drainage, or EUS-Guided Rendezvous Technique?

Despite experienced hands and availability of various well-designed catheters and wires, selective bile duct cannulation may still fail in 10–20% of cases during endoscopic retrograde cholangiopancreatography (ERCP). In case standard ERCP cannulation technique fails, salvage options include advanced ERCP cannulation techniques such as double-guidewire technique (DGW) with or without pancreatic stenting and precut papillotomy, percutaneous biliary drainage (PBD), and endoscopic ultrasound-guided Rendezvous (EUS-RV) ERCP. If the pancreatic duct is inadvertently entered during cannulation attempts, DGW technique is a reasonable next step, which can be followed by pancreatic stenting to reduce risks of post-ERCP pancreatitis (PEP). Studies suggest that early precut papillotomy is not associated with a higher risk of PEP, while needle-knife fistulotomy is the preferred method. For patients with critical clinical condition who may not be fit for endoscopy, surgically altered anatomy in which endoscopic biliary drainage is not feasible, and non-communicating multisegmental biliary obstruction, PBD has a unique role to provide successful biliary drainage efficiently in this particular population. As endoscopic ultrasound (EUS)-guided biliary drainage techniques advance, EUS-RV ERCP has been increasingly employed to guide bile duct access and cannulation with satisfactory clinical outcomes and is especially valuable for benign pathology at centres where expertise is available. Endoscopists should become familiar with each technique’s advantages and limitations before deciding the most appropriate treatment that is tailored to patient’s anatomy and clinical needs.

Nonradiation-to-endoscopist ERCP is non-inferior to standard ERCP

BackgroundRadiation exposure is inherently involved in endoscopic retrograde cholangiopancreatography (ERCP), which could cause radiation-induced injury to endoscopists with long-term exposure. Nonradiation ERCP has been applied to pregnant patients. Conceivably, the same techniques could be used to benefit endoscopists. This study was designed to evaluate the effectiveness and safety of nonradiation-to-endoscopist (NRE) ERCP, compared with standard ERCP.MethodsA retrospective, single-center study was conducted from August 2010 to December 2015. Patients aged 18–90 years and with choledocholithiasis (< 15 mm) or distal biliary stricture were eligible. Pre-ERCP evaluation with magnetic resonance cholangiopancreatography was mandatory. To overcome selection bias, we performed 1:2 match using propensity score matching (PSM) between NRE and standard groups. The primary endpoint was overall ERCP success rate. Secondary endpoints were cannulation success rate, stone clearance rate, complication rate, and duration of hospitalization.ResultsA total of 329 patients met inclusion criteria. After PSM, 73 patients were included in the NRE group and 146 in the standard group. The ERCP overall success rate for NRE and standard groups was equivalent (94.5% vs. 93.2%, P = 0.70). There was no difference in cannulation success rates between the two groups (95.6% vs. 97.8%, P = 0.39). A total of 88.3% of patients in the NRE group and 93.9% of patients in the standard group had stones cleared at initial ERCP (P = 0.57). No difference in overall stone clearance rate between the two groups (95.0% vs. 93.9%, P = 0.77) was found after second ERCP. The complication rate (1.4% vs. 1.4%, P = 1.00) and hospital duration (8.3 ± 5.1 vs. 10.2 ± 8.8 days, P = 0.07) were not different between the two groups.ConclusionAlthough technically demanding, NRE-ERCP is both safe and feasible in selected patients compared with standard ERCP.

Acute papillary stone impaction: An ideal indication for upfront needle knife papillotomy ("needle knife excision").

Needle knife papillotomy (NKP) is still considered a rescue technique after conventional access failure due to traditional high complication rates, albeit data are maturing for early use of NKP in standard endoscopic retrograde cholangiopancreatography indications. By contrast, in certain settings NKP should be prioritized to a first‐class indication, such as in choledochocele management and/or, more often encountered in clinical practice, true papillary stone impaction with or without gallstone pancreatitis. The latter results in prompt stone release; thus, the procedure might become alternatively designated as “needle knife excision.”

ID: 3525682 IN A PINCH: USE OF SMALL CALIBER DILATING BALLOONS DURING ERCP FOR SALVAGE TREATMENT OF HIGH-GRADE BILIARY AND PANCREATIC DUCT STRICTURES

Biliary and pancreatic strictures can often be challenging to manage with endoscopic retrograde cholangiopancreatography (ERCP). Very tight strictures can be difficult to traverse with standard ERCP accessories. The aim of this study is to describe the use and outcomes of SCDBs for management of biliary and pancreatic duct strictures.

ID: 3520457 OUTCOMES OF LAPAROSCOPIC-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY VERSUS PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE IN PATIENTS WITH ROUX-EN-Y GASTRIC BYPASS SURGERY

Patients with history of Roux-en-Y gastric bypass (RYGB) surgery are not candidates for standard endoscopic retrograde cholangiopancreatography (ERCP) due to their surgically altered gastrointestinal anatomy. There are a number of alternative approaches in such patients including device-assisted ERCP, laparoscopy-assisted ERCP (LA-ERCP), endoscopic ultrasound-guided biliary drainage (EUS-BD), percutaneous transhepatic biliary drainage (PTBD) and surgical drainage. The aim of our study was to compare clinical outcomes in RYGB patients undergoing LA-ERCP versus PTBD for management of pancreatobiliary diseases.

Diagnostic Accuracy of Endoscopic Ultrasonography Versus the Gold Standard Endoscopic Retrograde Cholangiopancreatography in Detecting Common Bile Duct Stones.

Background and objectivesStone in the biliary tract is one of the most common causes of hospitalization. However, it is difficult to determine the prevalence of gallstones in the general population because they are often asymptomatic. Thus, management lies in the proper clearance of the common bile duct (CBD) along with the removal of the gallbladder, for which it must be diagnosed on time with proper accuracy. Imaging modalities including magnetic resonance cholangiopancreatography (MRCP), endoscopic ultrasound (EUS), and endoscopic retrograde cholangiopancreatography (ERCP) provide true visualization of choledocholithiasis with comparable sensitivities. The gold standard ERCP is an invasive procedure and may cause complications, such as pancreatitis, perforation, and bleeding. EUS is a minimally invasive procedure to assess the biliary tract using high-frequency sound waves. Until now the EUS has not been addressed much in our local tertiary care setups and this study was conducted to evaluate its accuracy in the diagnosis of choledocholithiasis. The objective of our study is to determine the diagnostic accuracy (specificity and sensitivity) of EUS versus ERCP for the diagnosis of choledocholithiasis.Materials and methodsThis retrospective study was conducted on patients suspected of having choledocholithiasis undergoing both EUS and ERCP based on their history, clinical symptoms, and laboratory test results including upper abdominal pain, deranged liver function enzymes, and a dilated CBD on radiology. EUS was initially performed for the diagnosis of extrahepatic biliary obstruction followed by one or more of the confirmatory criterion standard tests (including ERCP). In order to reduce the chances of passage of stone resulting in negative analysis, only those patients were included in which both procedures were conducted temporally close together (24-72 hours in most instances). The main outcome measures were diagnostic accuracy with the help of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) using a receiver operating characteristic curve. A total of 123 patients met the inclusion criteria via non-probability consecutive sampling methods.ResultsThe mean age of our study population was 50.30 ± 13.91. We included 63 males (51.2%) and 60 females (48.8%). The most frequent indication for undergoing diagnostic procedures was deranged liver function tests (67.47%). The frequent comorbidities reported were hypertension (29.26%), diabetes (21.95%), chronic liver disease (16.26%), and ischemic heart disease (4.87%). Mean alkaline phosphatase and gamma-glutamyl transferase levels were markedly raised from the baseline in the study population. Post-ERCP complications were also reported in some of the study participants. About 85 patients (69.10%) were diagnosed with choledocholithiasis among the study participants. The diagnostic accuracy of EUS was compared with ERCP revealed an area under the curve (AUC) of 0.930, standard error of 0.031, 95% confidence interval of 0.868-0.991, the sensitivity of 89.5%, specificity of 96.5%, positive predictive value of 91.9%, and negative predictive value of 95.3%.ConclusionIt is recommended that ERCP can be selectively conducted or excluded in patients with biliary obstruction in case of EUS negative, thus minimizing the complications and morbidity associated with an invasive procedure, with our results showing a comparative diagnostic accuracy of EUS.

Determining the Indeterminate Biliary Stricture: Cholangioscopy and Beyond.

Indeterminate biliary strictures (IDBS) continue to be an area of frustration for clinicians. Standard endoscopic retrograde cholangiopancreatography (ERCP) with conventional brush cytology and/or forceps biopsy has a low sensitivity for distinguishing benign from malignant biliary strictures. A delay in diagnosis of malignancy has consequences for subsequent therapy or surgery. In this article, we review current and emerging technologies that may aid in this diagnostic dilemma. Several technologies have been utilized in IDBS to establish a diagnosis which include peroral cholangioscopy, confocal laser endomicroscopy, endoscopic ultrasound with fine needle aspiration, intraductal ultrasound, optical coherence tomography, fluorescence in situ hybridization, next generation sequencing, integrated molecular pathology, and DNA-image cytometry. While cholangioscopy and confocal laser endomicroscopy have become standards of care in expert centers for the evaluation of patients with IDBS, there are several endoscopic and molecular modalities that may also aid in establishing a diagnosis. Further head-to-head prospective diagnostic studies as well as cost-efficacy studies are needed.

Issue Highlights

Issue Highlights

Su1521 EARLY SINGLE-OPERATOR CHOLANGIOSCOPY ASSISTED ELECTROHYDRAULIC LITHOTRIPSY (SOC-EHL) IN THE MANAGEMENT OF DIFFICULT BILIARY STONES IS COST-EFFECTIVE WHEN COMPARED TO A DELAYED STEP-UP APPROACH TO SOC-EHL

Single-operator cholangioscopy assisted electrohydraulic lithotripsy (SOC-EHL) is the current standard of care for the management of difficult bile duct stones with failed clearance using conventional endoscopic retrograde cholangiopancreatography (ERCP). This modality; however, is expensive and the optimal timing of its use, in terms of cost-effectiveness, in the management of difficult bile duct stone remains unclear. To determine the most cost-effective timing of SOC-EHL utilization in the endoscopic management of difficult common bile duct stones. Difficult stones were defined as having failed ductal clearance via standard ERCP. A decision model was developed assessing 3 strategies with progressively delayed sequences of SOC-EHL introduction in relation to initial failed ERCP, adopting a 6-month time horizon. Probability estimates for each health state were obtained from a systematic review of the literature. For each strategy, outpatients undergoing ERCP underwent different timings of SOC-EHL introduction with regards to the failed initial ERCP, and were followed for subsequent need for re-intervention, adverse events, need for surgery, and/or successful endoscopic ductal clearance. The unit of effectiveness was complete ductal clearance without need for surgery. Deterministic and probabilistic sensitivity analyses were performed varying sequentially or synchronously all 54 model variables across ranges spanning 30% of their respective values. Costs were expressed in 2018US$, based on national US data. The strategy of performing SOC-EHL at a next procedure following initial failed ERCP is the least expensive approach when compared to delaying SOC-EHL. This strategy costs US$18506 on average per patient with complete ductal clearance and save between US$390 to US$734 when compared to the other two strategies, which introduce SOC-EHL only at the second or third ERCP following the initial failed procedural attempt. Effectiveness is clinically comparable between the three strategies ranging from 97-99%. Deterministic and probabilistic sensitivity analyses show changes in the results with variations of probability assumptions but especially when varying costs of SOC-EHL, ERCP facility fees and failure rates. Although SOC-EHL is expensive, this analysis demonstrates that among patients who have failed a prior attempt at stone extraction, utilization of SOC-EHL at the first subsequent ERCP is most cost-effective when compared to its delayed introduction. The results however, can vary with changes in ERCP facility fees, the failure rates and SOC-EHL equipment costs.

Factors Associated with the Success Rate of Endoscopic Retrograde Cholangiopancreatography with Standard Technique followed by Laparoscopic Cholecystectomy in the Management of Choledocholithiasis: A Single-Center Experience

Abstract Background Choledocholithiasis is the most common benign biliary disease. Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC) has been the first-line therapy in recent years, although laparoscopic common bile duct exploration has promising results. This retrospective study aimed to define the factors associated with biliary clearance by standard ERCP technique and conversion rate of LC. Materials and Methods We retrospectively evaluated the records of 217 choledocholithiasis patients who had undergone ERCP with stone removal by the standard technique from 2010 to 2018. A failed ERCP was defined when the first ERCP session could not remove the stones . The number of patients who later underwent open cholecystectomy or LC was also recorded. Conversion was defined when LC had to be converted OC. Statistical Analysis Student’s t-test was used for the comparison of continuous variables. Nominal variables were analyzed using Pearson’s chi-square test or Fisher’s exact test. Binary logistic regression was performed for multivariate analysis. Results The rate of successful biliary clearance was 81.1%. Of the patients, 109 (50.2%) had difficult stones. Increasing age (p = 0.004), increasing number (p = 0.001), and increasing size of stone (p &lt; 0.001) were the three significant factors that were associated with the failure of biliary clearance. The difficult stone group had a higher failure rate of ERCP and a higher conversion rate of LC compared with the easy stone group (p = 0.001 and p = 0.027, respectively). Conclusions ERCP with the standard technique is a highly effective and safe management option for patients with common bile duct (CBD) stones. The difficult stone group was found to be an independent risk factor that affected the success rate of both ERCP and the following LC. Difficult stone criteria should be assessed to identify a patient who might benefit from laparoscopic CBD exploration.

Double balloon enteroscopy improves ERCP success in patients with modified small bowel anatomy.

OBJECTIVE:The aim of this study was to evaluate the effect of double-balloon enteroscopy (DBE) on the success of endoscopic retrograde cholangiopancreatography (ERCP) procedures in patients with surgically modified gastrointestinal (GI) tract anatomy.METHODS:The medical records of patients who underwent ERCP in the Gastroenterology Department of Kocaeli University School of Medicine hospital between December 2008 and September 2014 were examined. From the patient group that was scheduled to undergo DBE-ERCP, the details of cases in which ERCP via standard duodenoscope or DBE-ERCP was performed during the same session because standard ERCP failed were included. Procedure parameters, outcomes, and complications related to the procedure in both groups were analyzed. Patients who underwent the DBE-ERCP procedure directly, those who underwent push enteroscopy, or gastroscopy to evaluate the GI tract anatomy before the day of ERCP, and who underwent DBE-ERCP on a day other than the initial ERCP session were excluded. Afferent loop intubation, access to the major papilla, selective cannulation, therapeutic success rates, and the effect of DBE on overall procedure success were evaluated.RESULTS:Fifty-one patients with a history of BII gastrojejunostomy and 11 patients with hepaticojejunostomy (with or without Roux-en-Y) were included in the study. In all patients, the ERCP procedure was initiated with a standard duodenoscope. If intubation of the afferent loop was unsuccessful in reaching the major papilla or enterobiliary anastomosis, DBE was used. In 30 (48.4%) of the 62 patients whose GI tract was anatomically altered, the duodenoscope was successfully advanced to the ampulla and 27 (43.5%) were cannulated successfully. Thirty-one patients underwent DBE-ERCP. DBE reached the ampulla or enterobiliary anastomosis in 30 patients (96.8%) and selective choledocus cannulation was achieved in all patients but 3 (90%), including 1 patient with a hepaticojejunostomy. The overall ERCP success rate increased from 43.5% (27/62) to 87.1% (54/62). Two perforations (1 during standard duodenoscopy and 1 with DBE-ERCP) were observed.CONCLUSION:The overall success rate of ERCP increased with use of the DBE technique in patients with small bowel anatomic variations that were the result of previous surgery.

ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction

Background & aimsEndoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction.MethodsThe ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events.DiscussionThe ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design.Trial registrationRegistry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.

Gastric access temporary for endoscopy (GATE): a proposed algorithm for EUS-directed transgastric ERCP in gastric bypass patients.

Performing endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y gastric bypass (RYGB) anatomy is technically challenging. Device-assisted enteroscopy and laparoscopic-assisted methods suffer from high failure rates and/or post-procedural complications. A novel endoscopic technique termed EUS-Directed Transgastric ERCP (EDGE) or Gastric Access Temporary for Endoscopy (GATE) has recently emerged, demonstrating excellent technical and therapeutic success. The technique involves endoscopic ultrasound-guided deployment of a lumen-apposing metal stent (LAMS) to gain access into the remnant stomach to facilitate standard ERCP. In this case series, we describe our center's experience and unique approach with the GATE procedure and discuss several key strategies and differences. Patients underwent the GATE procedure via a novel algorithmic approach. Key information on procedural details, technical and clinical success, follow-up, and adverse events was prospectively collected and retrospectively reviewed. 10 patients underwent the GATE procedure from May 2017 to March 2018. Technical and clinical success were both 100%. Gastric and jejunal access points for LAMS deployment were 30% and 70%, respectively. Total procedure time per patient, including LAMS deployment, ERCP, and all follow-up procedures, averaged 2.37 ± 0.63h. 2 out of 10 patients (20%) had adverse events that were resolved either intra-procedurally or after repeat endoscopy with no long-term complications and none requiring surgery. For patients with complete follow-up (n = 7), access tract closure rate was 100% with the aid of a temporary plastic double pigtail stent to facilitate closure. GATE appears to be a safe and effective procedure and may be considered the preferred approach to ERCP in patients with RYGB anatomy at centers with LAMS experience. The procedure offers more definitive and higher range of ERCP interventions compared to traditional methods and is associated with fewer adverse events. Improvements in strategies and methods with the GATE technique may reduce risks and improve outcomes.

Role of digital single-operator cholangioscopy in the diagnosis and treatment of biliary disorders.

Due to the need for improvement in the diagnosis and minimally invasive therapy of the bile duct disorders new technologies for cholangioscopy have been recently developed. Per-oral cholangioscopy has become an important diagnostic and therapeutic tool leading to avoidance of aggressive and unnecessary surgery in many clinical scenarios. This paper focuses on the newly developed SpyGlass DS technology, its advantages, and the technique of single-operator cholangioscopy (SOC), biliary indications and possible adverse events. We also review the available literature; discuss the limitations and future expectations. Digital SOC (D-SOC) is a useful technique, which provides endoscopic imaging of the biliary tree, optical diagnosis, biopsy under direct vision and therapeutic interventions. The implementations are diagnostic and therapeutic. Diagnostic indications are indeterminate biliary strictures, unclear filling defects, staging of cholangiocarcinoma, staging of ampullary tumors (extension into the common bile duct), unclear bile duct dilation, exploring cystic lesions of the biliary tree, unexplained hemobilia, posttransplant biliary complications. Therapeutic indications are lithotripsy of difficult stones, retrieval of migrated stents, foreign body removal, guide wire placement, transpapillary gallbladder drainage and endoscopic tumor ablative therapy. Most studied and established indications are the diagnosis of indeterminate biliary stricture and intraductal lithotripsy of difficult stones. The adverse events are not different and more common compared to those of Endoscopic retrograde cholangiopancreatography (ERCP) alone. D-SOC is a safe and effective procedure, adjunct to the standard ERCP and the newly available digital technology overcomes many of the limitations of the previous generations of cholangioscopes.

The risk of post-ERCP pancreatitis after single operator peroral SpyGlass cholangioscopy is highest in the beginning of practice

Background: SpyGlass cholangioscopy (SOC) with intra-ductal visualisation and biopsies is an adjunct to endoscopic retrograde cholangio-pancreatography (ERCP) in the diagnostics of indeterminate biliary strictures. The rate of complications during the learning curve and after establishment of a routine in SOC practice was studied. Methods: All consecutive SOC performed in a tertiary referral center 2012 – 2015 were included. Data was collected prospectively for indications, procedure details and complications and supplemented from records for clinical outcome. Results: 1920 ERCP were performed during the study period. Of those 113 patients (5.9%; mean age 58 y, 57% male) underwent SOC ERCP. Median follow-up was 19 months (range 1 – 48). The indication for SOC was primary sclerosing cholangitis in 43%, indeterminate stricture in 30% and stone disease in 24%. 92% of SOCs were performed in outpatient setting. In the very first 25 SOC, the rate of adverse events was 20%: all 5 patients had a severe post-ERCP pancreatitis (PEP), one of which had fatal outcome In the next 88 SOCs rate of adverse events was 8% (PEP 3%, cholangitis 3%, bleeding 1%, mortality 0%, none severe). The sensitivity and specificity of SOC biopsies were 75% and 87% for detecting cancer, respectively. Conclusion: The risk of pancreatitis after SOC decreases to the level seen in standard ERCP as experience accumulates. SOC may be considered a safe diagnostic aid in unclear biliary strictures even in outpatient setting.