Japan multi-center study: Diagnostic and therapeutic ERC using a short double-balloon endoscope in patients with altered GI anatomy

Japan multi-center study: Diagnostic and therapeutic ERC using a short double-balloon endoscope in patients with altered GI anatomy - Japan DB-ERC Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010375

Enrollment

240

Registered

2013-04-01

Start date

2013-06-01

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

biliary disease

Interventions

double-balloon entdoscope

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age: 20 years old or older 2) To consent to an inclusion agreement 3) Patients with altered GI anatomy who have a Biliary disease(suspected)(except for gallstone pancreatitis)

Exclusion criteria

Exclusion criteria: 1) Patients with suspected intestinal perforation 2) Patients with anaphylaxis to natural rubber 3) Patients with a very bad general condition 4) Patients having severe blood clotting defect 5) Patients having severe another disease 6) Gravida and possibly pregnant patients 7) Patients whom the chief physician(or the physician in charge) considers to be inappropriate for entry into the trial

Design outcomes

Primary

Measure	Time frame
A success rate of reaching a targeted part (papilla/choledochojejunostomy part)	—

Secondary

Measure	Time frame
1) Judgment of safety () 2) A success rate of insertion to deeper parts of a Biliary tract 3) A success rate of treatments relevant to ERC ()The outcomes described above are determined by a point of view to assess efficacy of DBE regarding treatments of a Biliary tract for patients with altered GI anatomy. The items and classifications about safety are determined as follows by a point of view to assess safety of DBE regarding diagnosis and treatment of a Biliary tract for patients with altered GI anatomy. Grade 1 No problem: There waren't any problems at all. Grade 2 Light problem: There were light problems during or after examination. But it was not necessary to treat specifically. Grade 3 Problem: There were some problems during or after examination. And it was necessary to treat specifically or keep patients in observation. Grade 4 Severe problem: There were severe problems during or after examination. The examination was stopped or should be stopped. Grade 5 Death due to the trial: To describe a reason.	—

Measure

Time frame

1) Judgment of safety (*) 2) A success rate of insertion to deeper parts of a Biliary tract 3) A success rate of treatments relevant to ERC (*)The outcomes described above are determined by a point of view to assess efficacy of DBE regarding treatments of a Biliary tract for patients with altered GI anatomy. The items and classifications about safety are determined as follows by a point of view to assess safety of DBE regarding diagnosis and treatment of a Biliary tract for patients with altered GI anatomy. Grade 1 No problem: There waren't any problems at all. Grade 2 Light problem: There were light problems during or after examination. But it was not necessary to treat specifically. Grade 3 Problem: There were some problems during or after examination. And it was necessary to treat specifically or keep patients in observation. Grade 4 Severe problem: There were severe problems during or after examination. The examination was stopped or should be stopped. Grade 5 Death due to the trial: To describe a reason.

—

Countries

Japan

Contacts

Public ContactMasaaki Shimatani

Kansai Medicine University Division of Gastroenterology and Hepatology

shimatam@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

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