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Comparative study of the conventional catheter and the new device for cannulation in difficult ERCP case: a multicentre, crossover, randomised controlled trial.

Comparative study of the conventional catheter and the new device for cannulation in difficult ERCP case: a multicentre, crossover, randomised controlled trial. - The evaluation of the new device for cannulation for difficult case on ERCP.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026232
Enrollment
64
Registered
2017-02-21
Start date
2017-03-10
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

pancreatobliary disease

Interventions

Objective patient is selected group A (conventional method) or group B (new device). Operator perform ERCP according to the selection. In each group, ERCP catheter will be changed if it is difficult

Sponsors

Department of Gastroenterology. Fukushima Medical University Aizu Medical center.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) the patient who is necessary to perform ERCP, especially insertion into the bile duct. 2) The patient that a document agreement by the free will of a patient was provided after enough understanding after having received enough explanation about inspection. 3) age more than 20 y/o

Exclusion criteria

Exclusion criteria: 1) Performance Status (PS)4 2) Patient having previous treatment for ampulla. 3) Status after gastrectomy 4) Having the serious complications in other organs 5) There is no informed consent. 6) Subjects judged as inappropriate candidates for the trial by the investigators.

Design outcomes

Primary

MeasureTime frame
success rate of deep biliary cannulation

Secondary

MeasureTime frame
1. time for success 2. kind of used guide wire 3. kind of used catheter

Countries

Japan

Contacts

Public ContactHiromu Kutsumi

Shiga University of Medical Science Hospital Center for clinical research and development

hkutsusmi@belle.shiga-med.ac.jp077-548-3665

Outcome results

None listed

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