Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial.

Importance: Infection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument. Objective: To determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs. Design, Setting, and Participants: In this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible. Intervention: The intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design. Main Outcomes and Measures: Coprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers. Results: From December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP. Trial Registration: ClinicalTrials.gov Identifier: NCT04040504.

Efficacy of Common Bile Duct Stenting on the Reduction in Gallstone Migration and Symptoms Recurrence in Patients with Biliary Pancreatitis Who Were Candidates for Delayed Cholecystectomy.

BACKGROUND: In patients with severe biliary pancreatitis, delayed cholecystectomy associated with a high risk of recurrence is recommended. The current study aimed to evaluate the effect of common bile duct (CBD) stenting on reducing gallstones migration and recurrence of symptoms in patients with pancreatitis and delayed cholecystectomy candidates. METHODS: To this purpose, the randomized, controlled clinical trial was performed on 40 patients with biliary pancreatitis who were candidates for delayed cholecystectomy. Patients were randomly divided into two groups of A and B that underwent CBD stenting after ERCP and received endoscopic treatment without stenting, respectively. A checklist recorded demographics and complications. Group A was followed up after four weeks to remove the stent and record the complications. Group B underwent MRCP to examine the migration of new gallstones as well as the complications. RESULTS: Of the 40 patients, 20 subjects (11 males and 9 females) were allocated to each group, matched for demographic variables. In the one-month follow-up, only one subject in group A manifested symptoms of gallstone migration and recurrence, while in group B, recurrence was observed in 6 patients (P = 0.037). There was no significant difference in the success rate of ERCP and the incidence of complications between the two groups. CONCLUSION: CBD stenting in patients with biliary pancreatitis and gallstone could reduce the risk of recurrence and remigration of gallstones in delayed cholecystectomy cases.

Colonic diverticular perforation by a migrated biliary stent: A case report with literature review.

RATIONALE: Plastic endobiliary stents, after endoscopic retrograde cholangiopancreatography, can get spontaneously dislocated from the common bile duct and migrate intothe distal bowel. Most migrated biliary stents are removed with the passing of stool. However, migrated biliary stents can cause bowel perforation, albeit rarely, and surgical intervention may be required. Recently, we observed a colonic diverticular perforation caused by a migrated biliary stent, and we have reported this case with a review of the literature. PATIENTS CONCERNS: A 74-year-old man presented with severe right lower quadrant pain after biliary stent insertion 1month ago. DIAGNOSES: Abdominal computed tomography revealed perforation of the proximal ascending colon by the migrated biliary stent, combined with localized peritonitis. INTERVENTIONS: Emergency diagnostic laparoscopic examination revealed penetration of the proximal ascending colon by the plastic biliary stent, and right hemicolectomy was performed. OUTCOMES: On pathological examination, colonic diverticular perforation by the biliary stent was confirmed. The patient was discharged without any additional complications. LESSONS: Endoscopic retrograde cholangiopancreatography endoscopists must always be cautious of the possibility of stent migration in patients with biliary stents in situ. In cases of biliary stent dislocation from the common bile duct in asymptomatic patients, follow-up with serial, plain abdominal radiographs, and physical examination is needed until confirmation of spontaneous passage through stool. In symptomatic cases suggesting peritonitis, abdominal computed tomography scan confirmation is needed, and early intervention should be considered.

Management of biliary diseases after the failure of initial needle knife precut sphincterotomy for biliary cannulation.

Endoscopic retrograde cholangiopancreatography is not always successful even with needle knife precut sphincterotomy (NKPS). How to manage these patients with initial NKPS failure has not been well studied. We report the outcomes of patients who received endoscopic and non-endoscopic rescue treatment after the initial NKPS failure. During the 15 years from 2004 to 2018, 87 patients with initial NKPS failure received interval endoscopic treatment (IET group, n = 43), percutaneous transhepatic biliary drainage (PTBD group, n = 25), or bile duct surgery (BDS group, n = 19) were retrospectively studied. Compared with the PTBD group, the prevalence of choledocholithiasis was higher (69.8% vs. 16.0%, p < 0.001), and malignant bile duct stricture were lower (20.9% vs. 76.0%, p < 0.001) in the IET group. Furthermore, the IET group had a significantly longer time interval between the first and second treatment procedures (4 days vs. 2 days, p = 0.001), a lower technique success rate (79.1% vs. 100%, p = 0.021), and a shorter length of hospital stay (7 days vs. 18 days, p < 0.001). Compared to the BDS group, the only significant finding was that the patients in the IET group were older. Although not statistically significant, the complication rate was lowest in the IET group (7.0%) while highest in the BDS group (15.8%). Complications in the IET group were also mild, as compared with the other two groups. In conclusion, IET should be considered after initial failed NKPS for deep biliary cannulation before contemplating more invasive treatment such as BDS. PTBD may be the alternative therapy for patients with malignant biliary obstruction.

Tissue sampling for biliary strictures using novel elbow biopsy forceps.

We aim to evaluate the safety and feasibility of novel elbow biopsy forceps with a prebent head for sampling biliary strictures in our institution. A total of 24 patients (15 males and 9 females) with biliary stricture who underwent biliary biopsy during endoscopic retrograde cholangiopancreatography (ERCP) using novel elbow biopsy forceps from June 2019 to August 2020 were retrospectively included. The novel biopsy forceps had a head angulation of 30 degrees and were able to cannulate the bile duct and approach the biliary strictures easily to obtain adequate samples. The technical success rate, incidence of adverse events, and consistency of pathological and surgical specimens were assessed. This device was used successfully in all patients. A total of 52 biopsy specimens were obtained from 24 patients, and all specimens could be used for histopathological examination. Seventeen patients were diagnosed with malignancy based on biopsies, and all of them underwent surgical treatment. The histopathological findings of the biopsy specimens were in accordance with the postoperative pathology diagnoses. One of the seven patients was diagnosed with a benign lesion that was proven to be malignant during surgical treatment in the follow-up period. Two patients experienced a single episode of acute pancreatitis and recovered shortly after appropriate treatment. No patients experienced biliary perforation or biliary bleeding. Biopsy using novel elbow forceps in patients with biliary stenosis is feasible and safe. The novel device and related biopsy technique may be widely applied for biliary disease differentiation.

Device profile of the EXALT Model D single-use duodenoscope for endoscopic retrograde cholangiopancreatography: overview of its safety and efficacy.

Introduction: The management of pancreaticobiliary disorders relies heavily on endoscopic retrograde cholangiopancreatography, which is performed with a duodenoscope. Bacterial colonization of reusable duodenoscopes leading to subsequent infectious outbreaks is well recognized and remains an issue despite efforts to optimize best practices in high-level disinfection. The EXALT Model D duodenoscope (EXALT) (Boston Scientific Corporation, Marlborough, MA) is a single-use device, designed to achieve technical equivalency with reusable devices while eliminating the potential for device-related outbreaks.Areas covered: This review covers the challenges associated with reprocessing duodenoscopes and the development of duodenoscope-related infections, with an emphasis on the use of single-use duodenoscopes as a potential solution to this issue.Expert Opinion: Duodenoscope-related infections are an increasingly recognized problem. Infectious outbreaks harm patients, significantly affect providers and medical centers, and can erode patient trust in the health-care system. Single-use duodenoscopes eliminate both the risk of device-related infection transmission and the need for burdensome duodenoscope reprocessing. In clinical evaluations, the EXALT device has demonstrated an equivalent technical performance and provider satisfaction compared to reusable duodenoscopes. Increasing use of this device will clarify how it compares to reusable duodenoscopes in a variety of clinical settings among endoscopists of varying skills levels.

Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicenter randomized controlled trial.

INTRODUCTION: In patients with malignant distal bile duct obstruction and normal gastrointestinal anatomy, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is indicated when endoscopic retrograde cholangiopancreatography (ERCP) fails. The ERCP drainage route passes through the tumor, whereas the EUS-CDS route does not. Therefore, EUS-CDS is expected to have a longer stent patency than ERCP. However, for first-line biliary drainage, it remains unclear whether EUS-CDS or ERCP is superior in terms of stent patency. To reduce the frequency of highly adverse events (AEs) such as bile peritonitis or stent migration following EUS-CDS, we developed an antimigration metal stent with a thin delivery system for tract dilatation. This study is designed to assess whether EUS-CDS with this novel stent is superior to ERCP with a traditional metal stent in terms of stent patency when the two techniques are used for first-line drainage of malignant distal biliary obstruction. METHODS/DESIGN: This study is a multicenter single-blinded randomized controlled trial (RCT) involving 95 patients in four tertiary centers. Patients with malignant distal biliary obstruction that is unresectable or presents a very high surgical risk and who pass the inclusion and exclusion criteria will be randomized to EUS-CDS or ERCP in a 1:1 proportion. The primary endpoint is the stent patency rate 180 days after stent insertion. Secondary outcomes include the rates of technical success, clinical success, technical success in cases not requiring fistulous-tract dilation (only EUS-CDS group), procedure-related AEs, re-intervention success, patients receiving post-drainage chemotherapy, procedure time, and overall survival time. DISCUSSION: If EUS-CDS is superior to ERCP in terms of stent patency and safety for the first-line drainage of malignant distal biliary obstruction, it is expected that the first-line drainage method will be changed from ERCP to EUS-CDS, and that interruption of chemotherapy due to stent dysfunction can be avoided. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), ID: UMIN000041343. Registered on August 6, 2020. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047201Version number: 1.2, December 7, 2020.

Tratamiento quirúrgico de neoplasia mucinosa papilar intraductal de la vía biliar diagnosticada mediante SpyGlass(R) / No disponible

Presentamos el caso de un varón de 76 años con antecedente de colecistitis aguda intervenido mediante colecistectomía laparoscópica. Intraoperatoriamente, se evidenció una colecistitis crónica con conducto cístico engrosado. La anatomía patológica informó de displasia de alto grado que afectaba al borde distal del cístico. Ante los hallazgos, se practicó colangiopancreatografía retrógrada endoscópica (CPRE) con SpyGlass(R) con la cual se observó, adyacente a la unión del cístico-colédoco, lesión excrecente sugestiva de malignidad. Se decidió nueva intervención quirúrgica y se realizó una resección de vía biliar extrahepática con linfadenectomía del hilio hepático y hepaticoyeyunostomía. El informe anatomopatológico definitivo informó de neoplasia mucinosa papilar intraductal pancreatobiliar con displasia de alto grado con márgenes libres

No disponible

Spontaneous proximal choledochoduodenal fistula, a rare complication of cholangiolithiasis

No disponible

Retained biliary plastic stents - lest we forget.

Prolonged indwelling of endoscopically placed biliary plastic stents may lead to complications. We conducted a retrospective analysis of patients who underwent endoscopic retrograde cholangio-pancreaticography (ERCP) at our centre in 2017 and were noted to have retained biliary plastic stents ( > 3 months after an index ERCP). A total of 127 patients had previously placed biliary plastic stents, out of which 45 (35.4%) were retained. The median age of the latter was 52 years (range = 22-79 years) with 27 (60%) patients being men. The median duration of the retained stents was 144 days (range = 94-3292 days). The majority of the patients were asymptomatic. However, 9 (20%) patients had cholangitis, 2 (4.4%) had choledocholithiasis, 2 (4.4%) had cholangitic abscess and 1 (2.2%) developed septicaemia. Fortunately, all these complications could be managed medically and endoscopically. Retention of biliary plastic stents is a problem often overlooked and underestimated in clinical practice. Various measures need to be instituted to create awareness of this entity to prevent undesirable outcomes.

Fifteen-Year Single-Center Experience of Biliary Complications in Liver Trauma Patients: Changes in the Management of Posttraumatic Bile Leak.

INTRODUCTION: Management of posttraumatic bile leak has evolved over time in our unit, from endoscopic retrograde cholangiopancreatography (ERCP) stenting to intraperitoneal drainage (IPD) alone as first-line treatment for intraperitoneal bile leak. MATERIALS AND METHODS: Retrospective review of liver trauma patients from 2002 to 2017. Demographics, time and mode of diagnosis of bile leak, management, and outcome were analyzed of the box plot. RESULTS: In 118 patients, there were 28 traumatic bile leaks. Eighteen were free intraperitoneal and 10 were localized bilomas. The median time of diagnosis was 6 days following injury. The modes of diagnosis were preemptive hepatobiliary scintigraphy (18), computed tomography (CT) or ultrasound (7), and laparotomy (3). Free intraperitoneal biliary leak management included 11 IPD alone, 3 IPD plus ERCP, 2 IPD plus transcystic biliary stent (TBS), 1 operative cholangiogram, and 1 no intervention. Median time of IPD duration was 7 days (4-95) in IPD alone versus 14 days (6-40) in IPD + ERCP/TBS (p = 0.3). Median inpatient length of stay was 13 days (8-44) in IPD alone versus 12 days (8-22) in IPD + ERCP/TBS (p = 0.4). CONCLUSION: Placement of IPD alone, as first-line treatment, is safe and effective in the management of intraperitoneal bile leaks, avoiding the costs and potential complications of ERCP.

Goff Septotomy Is a Safe and Effective Salvage Biliary Access Technique Following Failed Cannulation at ERCP.

BACKGROUND: Biliary cannulation is readily achieved in > 85% of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). When standard cannulation techniques fail, salvage techniques utilized include the needle knife precut, double wire technique, and Goff septotomy. METHODS: Records of patients undergoing ERCP from 2005 to 2016 were retrospectively examined using a prospectively maintained endoscopy database. Patients requiring salvage techniques for biliary access were analyzed together with a control sample of 20 randomly selected index ERCPs per study year. Demographic and clinical variables including indications for ERCP, cannulation rates, and adverse events were collected. RESULTS: A total of 7984 patients underwent ERCP from 2005 to 2016. Biliary cannulation was successful in 94.9% of control index ERCPs, 87.2% of patients who underwent Goff septotomy (significantly higher than for all other salvage techniques, p ≤ 0.001), 74.5% of patients in the double wire group and 69.6% of patients in the needle knife precut group. Adverse event rates were similar in the Goff septotomy (4.1%) and index ERCP control sample (2.7%) groups. Adverse events were significantly higher in the needle knife group (27.2%) compared with all other groups. CONCLUSIONS: This study represents the largest study to date of Goff septotomy as a salvage biliary access technique. It confirms the efficacy of Goff septotomy and indicates a safety profile similar to standard cannulation techniques and superior to the widely employed needle knife precut sphincterotomy. Our safety and efficacy data suggest that Goff septotomy should be considered as the primary salvage approach for failed cannulation, with needle knife sphincterotomy restricted to Goff septotomy failures.

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.

Endoscopic Biliary Large Balloon Dilation Lithotripsy for Giant and Impacted Stones Removal: A Western Series.

BACKGROUND: Endoscopic removal of packed, large, or impacted stones, in which a basket cannot be deployed or is unable to grasp the stone(s), is challenging and inevitably leads to repeated procedures such as stent insertion and extra- or intracorporal lithotripsy. In this study, we describe the results of an alternative stone disintegration technique in a considerable series of patients using an esophageal/pyloric balloon for stone fragmentation or making working space in the bile duct to allow the deployment of the basket, a technique we call endoscopic biliary large balloon lithotripsy. METHODS: We retrieved data from 1,429 endoscopic retrograde cholangiopancreatographies (ERCPs) from 2 prospective trials performed between 2014 and 2019. Patients with difficult bile duct stones, in which a balloon dilator up to 15 mm was used to crush or increase the working space parallel to the stones in the common or hepatic duct, were included in the study. RESULTS: From the 1,429 ERCPs, 299 had difficult stones (>1 cm, impacted or multiple stones). Large balloon lithotripsy was employed in 46 cases after endoscopic papillotomy and endoscopic biliary large balloon dilation with failed attempted balloon or basket stone(s) extraction. Failure to clear the bile duct at first ERCP occurred in 4 cases (91.3% of success). Complications were observed in 5 patients (10.8%; 1 perforation, 1 pancreatitis, and 3 bleedings), who were treated conservatively. CONCLUSIONS: Large balloon lithotripsy, in order to crush the stones or make working room for baskets or balloons in the bile duct, is an effective, safe, and low cost technique for impacted, packed, or giant bile duct stones.

Use of an Ultra-slim Gastroscope to Accomplish Endoscopist-Facilitated Rescue Intubation During ERCP: A Novel Approach to Enhance Patient and Staff Safety.

BACKGROUND: ERCP is often performed under monitored anesthesia care (MAC) rather than general anesthesia (GA), with patients positioned semi-prone on the fluoroscopy table. Rarely, a MAC ERCP must be converted to GA due to hypoxia or retained food in the stomach. In these circumstances, standard intubation is associated with a significant delay and potential for patient/staff injury during repositioning. We report a novel endoscopist-driven approach to intubation during ERCP using an ultra-slim, flexible gastroscope with an endotracheal tube backloaded onto it. MATERIALS AND METHODS: We identified patients who underwent ERCP from 2014 to 2019, and MAC to GA conversion events. Mode of intubation (standard vs. endoscopist-facilitated) and patient/procedure characteristics were evaluated. All endoscopist-facilitated intubations were performed under anesthesiologist supervision. RESULTS: A total of 3409 patients underwent ERCP; 1568 (46%) GA and 1841 (54%) MAC. Of these, 42 (2.3%) required intubation during ERCP and 16 underwent endoscopist-facilitated intubation due to retained food in the stomach and/or hypoxia. In 3 patients, aspirated material was suctioned from the trachea and bronchi using the ultra-slim gastroscope. Immediate post-procedure extubation was successful in all endoscopist-facilitated intubation patients and none exhibited radiographic evidence of aspiration pneumonia. CONCLUSIONS: Endoscopist-facilitated intubation using an ultra-slim flexible gastroscope is feasible and expeditious for MAC to GA conversion during ERCP. This technique is readily accomplished in the semi-prone position, while standard intubation requires patient transfer from fluoroscopy table to gurney, with associated delay/risks. These data suggest that further study of this approach is warranted, and this may be the most favorable approach for intubation during ERCP.