Unique ID issued by UMIN | UMIN000023297 |
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Receipt number | R000026853 |
Scientific Title | A Multicenter, Prospective Randomized Study comparing Fully Covered Metal Stent and Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer |
Date of disclosure of the study information | 2016/07/23 |
Last modified on | 2021/11/08 12:43:26 |
A Multicenter, Prospective Randomized Study comparing Fully Covered Metal Stent and Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer
Comparison of Metal Stent with Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer
A Multicenter, Prospective Randomized Study comparing Fully Covered Metal Stent and Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer
Comparison of Metal Stent with Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer
Japan | Asia(except Japan) |
Obstructive jaundice caused by resectable pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To compare preliminary placement of FCMS and PS for obstructive jaundice caused by resectable pancreatic cancer with preoperative endoscopic drainage through a randomized musticenter controlled study and to evaluate the rate of re-intervention as well as post operative complication.
Efficacy
Rate of re-intervention related to stent during the time from drainage to surgical operation
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
2
Treatment
Device,equipment |
Fully covered metal stent cohort
Plastic stent cohort
20 | years-old | <= |
Not applicable |
Male and Female
Patients are eligible for this Study if they meet all the criteria shown below.
Patients who are over 20 years old
Patients who are suspected to have a carcinoma of the head of the pancreas which is determined to be resectable from the image, and a resection is scheduled as of ERCP conduction timing.
Patients who show obstructive jaundice caused by biliary stricture
Patients with stricture occurring at middle or lower part of the biliary
Patients for whom NO preoperative chemical radiation therapy is planned
Patients are to be excluded from this Study if they conflict with any of the criteria shown below
Patients who have previously received the procedure of cholecystectomy or endoscopic sphincterotomy
Patients who score 4 in Performance Status
Patients with serious complication on other organ(s): Higher than 3 with ASA category (dialyzed patients are also excluded)
Patients judged to have less than 3 months of life expectancy
70
1st name | |
Middle name | |
Last name | Takao Itoi |
Tokyo Medical University Hospital
Department of Gastroenterology
6-7-1 Nishi-Sinjyuku-ku, Tokyo
03-3342-6111
itoi@tokyo-med.ac.jp
1st name | |
Middle name | |
Last name | Takayoshi Tsuchiya |
Tokyo Medical University Hospital
Department of Gastroenterology
6-7-1 Nishi-Sinjyuku-ku, Tokyo
03-3342-6111
tsuchiya@tokyo-med.ac.jp
Tokyo Medical University Hospital
None
Other
NO
2016 | Year | 07 | Month | 23 | Day |
Unpublished
Completed
2016 | Year | 02 | Month | 26 | Day |
2016 | Year | 02 | Month | 26 | Day |
2016 | Year | 08 | Month | 01 | Day |
2020 | Year | 08 | Month | 31 | Day |
2016 | Year | 07 | Month | 22 | Day |
2021 | Year | 11 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026853
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