Unique ID issued by UMIN | UMIN000022164 |
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Receipt number | R000025539 |
Scientific Title | Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture. |
Date of disclosure of the study information | 2016/07/15 |
Last modified on | 2019/05/04 23:13:22 |
Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.
Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.
Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.
Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.
Japan |
Benign biliary stricture and benign pancreatic stricture
Hepato-biliary-pancreatic medicine |
Others
NO
A standard therapeutic strategy for benign biliary stricture or benign pancreatic stricture is indwelling multiple plastic stents and scheduled stent exchange. A disadvantage of this therapy is that patients have to receive several sessions of ERCP, and there exist some refractory cases who repeat stent exchange for a long time. The objective of present study is to evaluate the rate of stricture resolution and the safety of newly designed covered metallic stent for benign biliary and pancreatic strictures.
Safety,Efficacy
Exploratory
Rate of stricture resolution at stent removal after 90 days of indwelling.
1.Overall rate of stricture resolution at the end of the study period.
2.Rate of stricture recurrence and period until stricture recurrence.
3.Success rate of stent removal.
4.Adverse event at stent removal.
5.Other adverse events.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Insert a covered self-expandable metallic stent with a removal string (Niti-S Kaffes stent, Taewoong medical, Korea) into benign biliary and pancreatic stricture for 90 days.
20 | years-old | <= |
Not applicable |
Male and Female
1. Benign biliary stricture and benign pancreatic stricture (post-operative biliary stricture, post-liver transplantation bilio-biliary anastomotic stricture, biliary stricture by chronic pancreatitis, pancreatic stricture by chroninc pancreatitis, anastomotic stricture after choledochojejunostomy, and anastomotic stricture after pancreaticojejunostomy).
2. Patients with refractory stricture. (Stricture resolution was not achieved after 6 months of treatment by plastic stent insertion or PTBD insertion).
3. Malignant biliary or pancreatic stricture is ruled out by pathological examination and clinical course.
4. Patients with written informed consent.
1. Patients with difficulty in endoscopic approach to strictures.
2. Patients withpossibility of malignant biliary or pancreatic stricture.
3. Patients with performance status 3-4.
4. Patients with serious concomitant diseases such as heart failure, respiratory failure, or disturbance of consciousness and who cannot tolerate endoscopic procedures.
5. Patients considered ineligible by the attending physician.
30
1st name | Yousuke |
Middle name | |
Last name | Yousuke |
Graduate School of Medicine, The University of Tokyo
Department of Gastroenterology
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
ynakai-tky@umin.ac.jp
1st name | Tatsuya |
Middle name | |
Last name | Tatsuya |
Graduate School of Medicine, The University of Tokyo
Department of Gastroenterology
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
tatsusatou-tky@umin.org
Graduate School of Medicine, The University of Tokyo
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Self funding
The University of Tokyo, Clinical research support center
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-5800-8743
crctky-office@umin.ac.jp
NO
東京大学医学部附属病院(東京都)
2016 | Year | 07 | Month | 15 | Day |
Unpublished
30
Completed
2016 | Year | 06 | Month | 01 | Day |
2016 | Year | 05 | Month | 23 | Day |
2016 | Year | 07 | Month | 15 | Day |
2019 | Year | 03 | Month | 31 | Day |
2016 | Year | 05 | Month | 01 | Day |
2019 | Year | 05 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025539
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