A prospective randomized controlled multicenter trial of catheter and papillotome: effect on selective cannulation of the common bile duct in endoscopic retrograde cholangiopancreatography

A prospective randomized controlled multicenter trial of catheter and papillotome: effect on selective cannulation of the common bile duct in endoscopic retrograde cholangiopancreatography - Japan Bile duct cannulation Study (Japan BDCS)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002572

Enrollment

400

Registered

2009-10-01

Start date

2009-09-01

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

Pancreaticobiliary disease

Interventions

ERCP catheter Papillotome Contrast medium guidewire

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The study group included patients who required cholangiography and an intact papilla of Vater. Patients who are planned ERCP. Patients who fully understand and are willing to give a written informed consent about participation.

Exclusion criteria

Exclusion criteria: Performance status of 4 (Completely disabled. Cannot carry out any selfcare. Totally confined to bed or chair); severe heart disease; severe lung disease; age 20 years younger; pregnant and breast-feeding women or women suspected of being pregnant; women are not willing to avoid pregnancy during the duration of study; history of previous endoscopic sphincterotomy; previous endoscopic balloon dilatation; ampullary neoplasm and infiltration of the papillary area by pancreatic cancer; acute pancreatitis; chronic pancreatitis with an acute exacerbation; impacted common bile duct stone; Billroth II gastrectomy; Roux-en-Y reconstruction; separate orifices of the common bile duct and pancreatic duct on the papilla; pancreaticobiliary maljunction; biliary cannulation using with Rendezvous method; contrast medium allergy; or refusal to provide informed consent.

Design outcomes

Primary

Measure	Time frame
The main outcome measurement was successful or failed selective cannulation of the common bile duct with wire-guided catheter or hydrophilic guidewire within a period of 10 minutes.	—

Countries

Japan

Contacts

Public ContactMidori NISHIOKA

Hokkaido University Hospital Clinical research head office

midorin@med.hokudai.ac.jp011-716-1161

Outcome results

None listed

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