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

Rotatable catheters versus conventional catheters for selective bile duct cannulation using balloon-assisted endoscopy in patients with surgically altered gastrointestinal anatomy: A multicenter prospective randomized trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1062240114

Enrollment

104

Registered

2025-01-24

Start date

2025-02-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with surgically reconstructed intestines who require evaluation the bile duct.

Interventions

In accordance with the allocation results, either a rotating catheter or a conventional catheter will be used for biliary cannulation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Biliary cannulation rate within 10 minutes.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactYuki Fujii

Okayama University Hospital

pmug1j9r@s.okayama-u.ac.jp+81-86-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026