Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy
NCT ID: NCT06010576
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
188 participants
INTERVENTIONAL
2023-09-05
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The implication of failed endoscopic biliary access can be substantial for the following reasons: higher risk of post-ERCP pancreatitis (PEP), need for rescue procedures such as external biliary drainage by interventional radiology, risks of external biliary drainage catheter-related complications including catheter blockage.
Advanced ERCP cannulation techniques such as pancreatic guidewire-assisted biliary cannulation with or without pancreatic stenting, and precut papillotomy are recommended by guidelines in patients with difficult bile duct cannulation, but they are not without limitations. If pancreatic duct cannulation is not feasible or pancreatic guidewire-assisted biliary cannulation fails, precut papillotomy using 1 of the 3 accepted precut techniques: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome, can be performed depending on institutional expertise. Despite a higher biliary cannulation success by precut papillotomy when compared to pancreatic guidewire-assisted biliary cannulation, a higher risk of PEP has also been traditionally associated with precut papillotomy when it is performed after prolonged cannulation attempts. On the other hand, there has been growing evidence to suggest the increased risk of PEP may be related to the persistent cannulation attempts before precut rather than the precut papillotomy itself. In a recent meta-analysis of 5 randomized controlled trials comparing "early precut papillotomy" to persistent standard cannulation techniques in ERCP by attending endoscopists and advanced endoscopy trainees, the incidence of PEP was not significantly different between the "early precut papillotomy" and the persistent standard cannulation groups.
EUS-guided rendezvous technique (EUS RV) is a novel advanced interventional EUS technique that has been increasingly performed in tertiary centers for patients with failed biliary access by advanced ERCP cannulation techniques. Several variations of EUS-guided biliary drainage procedures have been described including transpapillary drainage procedures (EUS RV for biliary access, EUS-guided antegrade stenting) and transmural drainage procedures (EUS-guided choledochoduodenostomy, EUS-guided hepaticogastrostomy). EUS RV can be applied in both benign and malignant biliary conditions as a salvage technique for difficult biliary access when the major papilla is accessible. EUS RV involves the following key steps: access of the dilated bile duct by a EUS needle under EUS guidance, performance of cholangiogram, advancement of the rendezvous guidewire into the bile duct and out of the major papilla into duodenum, and exchange of echoendoscope back to a duodenoscope to complete the procedure by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire. Because EUS RV achieves biliary access by targeting the dilated bile duct with antegrade passage of guidewire from bile duct through the papillary orifice, theoretically this would carry a lower risk of procedure-related PEP when compared to early precut papillotomy.
In a recently published consensus guidelines on the optimal management in interventional EUS procedures proposed by experts from our endoscopy research group and other member institutions of the Asian EUS Group, EUS-guided biliary drainage is recommended as the procedure of choice for biliary drainage in patients with failed ERCP when expertise is available based on high level evidence. The technical success of EUS RV has increased over time to 73% to 100% in studies published after 2012.
Studies directly comparing EUS RV and precut papillotomy in patients with difficult biliary access remain scarce. In a single center retrospective study published in 2012 comparing the clinical outcomes of 58 EUS RV procedures and 144 precut papillotomy procedures in patients with failed bile duct cannulation in ERCP, Dhir V et al reported a significantly higher first session technical success of biliary access (98% vs 90%, p = 0.038) and a lower adverse event rate (3.4% vs 6.9%, p = 0.27) in the EUS RV group. In a multicenter retrospective study published in 2017 by Lee A et al comparing the clinical outcomes of 50 EUS RV + 11 EUS-guided transmural drainage procedures and 142 precut papillotomy procedures in patients with failed bile duct cannulation in ERCP, a higher technical success of biliary access (94% vs 75%) was also demonstrated in the EUS RV group.
Despite the promising results of EUS RV in patients with failed biliary cannulation by advanced ERCP techniques, there has been no dedicated randomized controlled trial directly comparing EUS RV and early precut papillotomy in patients with difficult bile duct cannulation. We aim to conduct a multicenter randomized controlled trial comparing the clinical efficacy of these 2 advanced endoscopic biliary access techniques in patients with difficult bile duct cannulation in ERCP.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EUS-guided rendezvous group (EUS RV group)
In the EUS RV group, a linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.
EUS-guided rendezvous
A linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.
Early precut papillotomy group (EPP group)
In the EPP group, the precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome
Early precut papillotomy group
The precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EUS-guided rendezvous
A linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.
Early precut papillotomy group
The precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Native major papilla
* Difficult bile duct cannulation, defined by the presence of 1 of the following: 1) unsuccessful bile duct cannulation within 10 cannulation attempts, 2) unsuccessful bile duct cannulation within 10 minutes spent in cannulation, or 3) 2 unintended pancreatic duct cannulation or opacification with contrast
* Written informed consent available
Exclusion Criteria
* Contraindications for endoscopy due to comorbidities
* Prior biliary sphincterotomy
* Surgically altered upper gastrointestinal anatomy or duodenal obstruction precluding a standard ERCP
* Uncorrectable coagulopathy (INR \> 1.5) and thrombocytopenia (platelet \< 50,000) by blood product transfusion
* Pregnant patients
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tokyo University
OTHER
Gifu University Graduate School of Medicine
OTHER
Chinese University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Raymond Shing Yan Tang
Assitant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Raymond Tang, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Prince of Wales Hospital, The Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Felix Sia, BS
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021.720-T
Identifier Type: -
Identifier Source: org_study_id