Unique ID issued by UMIN | UMIN000012734 |
---|---|
Receipt number | R000014878 |
Scientific Title | A prospective randomized comparative study of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures |
Date of disclosure of the study information | 2013/12/31 |
Last modified on | 2015/01/17 17:46:58 |
A prospective randomized comparative study of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures
Comparision of a novel anti-reflux metal stent with partial covered metal stent for distal malignant biliary strictures
A prospective randomized comparative study of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures
Comparision of a novel anti-reflux metal stent with partial covered metal stent for distal malignant biliary strictures
Asia(except Japan) |
Inoperable distal malignant biliary stircutres
1) Common bile duct cancer
2) Pancreatic head cancer
3) Gallbladder cancer
4) Other metastatic malignant biliary strictures
Gastroenterology | Hepato-biliary-pancreatic medicine |
Malignancy
NO
The aim of this study is to evaluate the role of a innovative anti-reflux valve in biliary metallic stents by comparision of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures
Efficacy
Others
Others
Not applicable
Stent occlusion
Clinical success
Complications
Stent patency
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
2
Treatment
Device,equipment |
Biliary drainage with a novel anti-reflux metal stent
Biliary drainage with a conventional partial covered metal stent
18 | years-old | < |
Not applicable |
Male and Female
1) Providing informed consent
2) Inoperable distal malignant biliary strictures
3) Distal malignant biliary strictures with high operative risk
4) Distal malignant biliary strictures on imaging studies
5) Histopathologically confirmed as malignancy
6) Stricture in distance above 2 cm from the bifurcation of bile duct
1) Refusal of this study
2) Plan for curative or palliative surgery
3) Stricture in distance within 2 cm from the bifurcation of bile duct
4) Risk of bleeding: PT-INR > 1.5, normal 0.85-1.25 or platelet count < 80,000/mm3, normal 150,000-450,000/mm3
5) Pregnant or breast-feeding women
6) Performance status < 3 (scales of the Eastern Cooperative Oncology Group)
132
1st name | |
Middle name | |
Last name | Jong Ho Moon |
SoonChunHyang University School of Medicine
Digestive Disease Center and Research Institute
1174 Jung-Dong, Wonmi-Ku, Bucheon 420-767, Korea
+82-32-621-5094
jhmoon@schmc.ac.kr
1st name | |
Middle name | |
Last name | Hyun Jong Choi |
SoonChunHyang University School of Medicine
Digestive Disease Center and Research Institute
1174 Jung-Dong, Wonmi-Ku, Bucheon 420-767, Korea
+82-32-621-5211
joseph@schmc.ac.kr
SoonChunHyang University School of Medicine
SoonChunHyang University School of Medicien
Self funding
Korea
NO
SoonChunHyang University School of Medicine, Buchoen Hospital, Korea
2013 | Year | 12 | Month | 31 | Day |
Unpublished
No longer recruiting
2013 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2015 | Year | 01 | Month | 03 | Day |
2015 | Year | 01 | Month | 04 | Day |
2013 | Year | 12 | Month | 31 | Day |
2015 | Year | 01 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014878