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Japan multi-center study: Efficacy of additional injection of contrast medium during endoscopic balloon dilation by using duble-balloon endoscope with a 3.2mm accessory channel

Japan multi-center study: Efficacy of additional injection of contrast medium during endoscopic balloon dilation by using duble-balloon endoscope with a 3.2mm accessory channel - Japan DBEBD AICM Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014943
Enrollment
50
Registered
2014-08-25
Start date
2014-08-25
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

Crohn&#39

Interventions

addition of contrast medium during endoscopic balloon dilation

Sponsors

Jichi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. More than 20 years old and less than 75 yesra old 2. Small intestinal stricture 3. More than 5cm in length of stricture 4. There are no following conditions in strictures. i) without fistula or abscess ii) without deep ulcer iii) without severe curvature

Exclusion criteria

Exclusion criteria: 1. acute abdomen 2. severe inflammation 3. pregnant woman 4. poor general condition patients who has risk for performing endoscopy such as ileus perforation of intestine pancreatitis respiratory disorder heart failure acquired hemophilia intestinal stricture large ulcer large tumor 5. ongoing anti coagulation therapy or anti platelet therapy 6. intolerance of polyethylene glycol only for transanal approach 7. patient who experienced entry of this study 8. patient who is judged to be unsuitable for this clinical trial

Design outcomes

Primary

MeasureTime frame
Visibility of stricture by fluoroscopy, before or while balloon dialation when performing endoscopic balloon dilation in three different diameter after endoscopic enteroclysis

Secondary

MeasureTime frame
1. Feasibiltiy of additional injection of contrast medium while inserting balloon catheter into accessory channel. 2. Visibility of stricture by fluoroscopy after additional injection of contrast medium 3. Check of Adverse event and it's Contents.

Countries

Japan

Contacts

Public ContactTomonori Yano

Jichi Medical University Department of medicine, Division of gastroeterology

tomonori@jichi.ac.jp+81-285-58-7348

Outcome results

None listed

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