Comparative Study of Catheters for Biliary Cannulation in balloon-assisted ERCP

JRCT ID: jRCT1062240114

Registered date:24/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with surgically reconstructed intestines who require evaluation the bile duct.
• Date of first enrollment: 18/02/2025
• Target sample size: 104
• Study type: Interventional
• Intervention(s): In accordance with the allocation results, either a rotating catheter or a conventional catheter will be used for biliary cannulation

Outcome(s)

• Primary Outcome: Biliary cannulation rate within 10 minutes.

Secondary Outcome

1:Biliary cannulation time
2:Method of biliary cannulation with the allocated catheter (if cannulation was successful)
3:Number of biliary approach attempts
4:Number of accidental pancreatic duct cannulations
5:Presence or absence of precut
6:Success or failure of biliary cannulation (rescue method if biliary cannulation failed)
7:All biliary cannulation methods used during the procedure, final biliary cannulation method
8:Biliary cannulation rate by the primary operator
9:Biliary cannulation rate with or without the retroflex position
10:Biliary cannulation rate by papilla morphology
11:Rate of EST (endoscopic sphincterotomy) performed in cases allocated to the rotatable catheter
12:Details of the endoscopic procedure performed
13:Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1: Patients with surgically reconstructed intestines (Billroth II or Roux-en-Y) who require evaluation or treatment of the bile duct.
2: Patients who are 18 years of age or older at the time of consent acquisition.
3: Patients who have received a sufficient explanation regarding participation in this study, fully understood the explanation, and voluntarily provided written informed consent.

Exclude criteria

1:Patients undergoing treatment using an endoscope other than a double-balloon endoscope.
2:Patients with a history of papillary intervention (endoscopic sphincterotomy or endoscopic papillary balloon dilation).
3:Patients with a tumor of the papilla.
4:Patients classified as ASA-PS (American Society of Anesthesiologists Physical Status) 4-5 .
5:Other patients deemed inappropriate for participation in the study by the principal investigator or co-investigators.

Related Information

• Primary Sponsor: Matsumoto Kazuyuki