Unique ID issued by UMIN | UMIN000044178 |
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Receipt number | R000050452 |
Scientific Title | Comparison of the duration of recurrent bile duct obstruction between two 10 French Plastic Stent and fully covered Self expandable metallic stent for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud |
Date of disclosure of the study information | 2021/05/17 |
Last modified on | 2023/01/18 14:20:47 |
Comparison of the duration of recurrent bile duct obstruction between two 10 French Plastic Stent and fully covered Self expandable metallic stent for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud
Comparison of the duration of recurrent bile duct obstruction between two 10 French PS and fully covered SEMS for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud
Comparison of the duration of recurrent bile duct obstruction between two 10 French Plastic Stent and fully covered Self expandable metallic stent for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud
Comparison of the duration of recurrent bile duct obstruction between two 10 French PS and fully covered SEMS for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud
Japan |
Patients with non-resected distal malignant bile duct obstruction
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To compare the duration of recurrent bile duct obstruction between two 10 French PS and one fully covered SEMS for unresected distal malignant bile duct stenosis using a multicenter, randomized, non-inferiority trial.
Efficacy
Comparison of the duration of recurrent bile duct obstruction between two 10 French PS and one fully covered SEMS for non-resected distal malignant bile duct stenosis.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Device,equipment |
Two 10 French plastic stent placement
One fully covered self expandable metallic stent placement
20 | years-old | <= |
100 | years-old | >= |
Male and Female
1. Patients with unresected distal malignant bile duct stenosis who have already undergone initial PS implantation and whose cholangitis and jaundice have been confirmed to have improved.
2. Patients who are 20 years of age or older and have obtained written consent from themselves or a substitute.
3. Patients who can undergo endoscopic papillotomy without antithrombotic medication or with withdrawal of medication.
4. Patients with no history of SEMS placement.
5. The upper margin of the bile duct stenosis has a margin of at least 2 cm above the bifurcation.
6. Performance states 1, 2, 3.
1. Cases in which endoscopic retrograde cholangiography is difficult.
2. Patients with peri-hilar bile duct obstruction.
3. Patients with altered gastrointestinal
anatomy excluding Billroth-I reconstruction.
4. Patients with serious complications in other organs.
5. Performance status 4
6. Cases of pregnancy or possible pregnancy
7. Cases deemed inappropriate by the principal investigator or sub-investigator
8. Underage patients(less than 20 years old)
134
1st name | Masafumi |
Middle name | |
Last name | Chiba |
The Jikei University school of medicine
Department of Endoscopy
105-08461
3-25-8, Nishi-Shimbashi, Minato-ku Tokyo Japan
+81334331113181
ccl09720@gmail.com
1st name | Masafumi |
Middle name | |
Last name | Chiba |
The Jikei University School of Medicine, Tokyo, Japan
Department of Endoscopy
105-8461
3-25-8, Nishi-Shimbashi, Minato-ku Tokyo Japan
+81334331113181
ccl09720@gmail.com
The Jikei University school of medicine
self-funding (The Jikei University school of medicine, Tokyo Japan)
Other
Katsushika Medical Center, The Jikei University School of Medicine, Tokyo, Japan.
The Jikei University Kashiwa Hospital. Chiba, Japan
Atsugi City Hospital, Kanagawa Japan.
Fuji City General Hospital, Shizuoka Japan.
Human Subjects Committee of Jikei University School of Medicine
3-25-8 Nishi-Shimbashi Minato-ku Tokyo Japan
+8133433111
rinri@jikei.ac.jp
NO
東京慈恵会医科大学葛飾医療センター
東京慈恵会医科大学柏病院
厚木市立病院
富士市立中央病院
2021 | Year | 05 | Month | 17 | Day |
Unpublished
none
Open public recruiting
2021 | Year | 03 | Month | 07 | Day |
2021 | Year | 03 | Month | 08 | Day |
2021 | Year | 05 | Month | 17 | Day |
2024 | Year | 05 | Month | 31 | Day |
2021 | Year | 05 | Month | 11 | Day |
2023 | Year | 01 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050452
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