Unique ID issued by UMIN | UMIN000014943 |
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Receipt number | R000017243 |
Scientific Title | 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 |
Date of disclosure of the study information | 2014/08/25 |
Last modified on | 2017/02/25 22:43:36 |
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
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
Japan |
Crohn's disease
Gastroenterology |
Others
NO
Efficacy of additional injection of contrast medium during endoscopic balloon dilation by using duble-balloon endoscope with a 3.2mm accessory channel
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Visibility of stricture by fluoroscopy, before or while balloon dialation when performing endoscopic balloon dilation in three different diameter after endoscopic enteroclysis
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Device,equipment |
addition of contrast medium during endoscopic balloon dilation
20 | years-old | <= |
75 | years-old | > |
Male and Female
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
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
50
1st name | |
Middle name | |
Last name | Hironori Yamamoto |
Jichi Medical University
Department of medicine, Division of gastroeterology
Yakushiji 3311-1, Shimotsuke-city, Tochigi, Japan
+81-285-58-7348
yamamoto@jichi.ac.jp
1st name | |
Middle name | |
Last name | Tomonori Yano |
Jichi Medical University
Department of medicine, Division of gastroeterology
Yakushiji 3311-1, Shimotsuke-city, Tochigi, Japan
+81-285-58-7348
tomonori@jichi.ac.jp
Jichi Medical University
FUJIILM Corporation
Profit organization
Japan
NO
日本医科大学(東京都)、名古屋大学(愛知県)、広島大学(広島県)、福岡大学筑紫病院(福岡県)、九州大学(福岡県)
2014 | Year | 08 | Month | 25 | Day |
Unpublished
Completed
2014 | Year | 08 | Month | 06 | Day |
2014 | Year | 08 | Month | 25 | Day |
2015 | Year | 04 | Month | 30 | Day |
2015 | Year | 06 | Month | 30 | Day |
2015 | Year | 06 | Month | 30 | Day |
2017 | Year | 07 | Month | 31 | Day |
2014 | Year | 08 | Month | 25 | Day |
2017 | Year | 02 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017243
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