Unique ID issued by UMIN | UMIN000037958 |
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Receipt number | R000043253 |
Scientific Title | A prospective randomized control trial comparing newly designed 7mm double-bare metal stent and 7mm single-bare metal stent in patient with hilar malignant biliary strictures. |
Date of disclosure of the study information | 2019/10/01 |
Last modified on | 2019/09/07 08:41:38 |
A prospective randomized control trial comparing newly designed 7mm double-bare metal stent and 7mm single-bare metal stent in patient with hilar malignant biliary strictures.
A prospective randomized control trial comparing double-bare metal stent and single-bare metal stent in patient with hilar malignant biliary strictures.
A prospective randomized control trial comparing newly designed 7mm double-bare metal stent and 7mm single-bare metal stent in patient with hilar malignant biliary strictures.
A prospective randomized control trial comparing double-bare metal stent and single-bare metal stent in patient with hilar malignant biliary strictures.
Japan |
Hilar malignant biliary obstruction
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficacy and sefety of double bare metal stent for patient with unresectable malignant hilar biliary obstruction.
Efficacy
Time to Recurrent Biliary Obstruction
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
2
Treatment
Device,equipment |
Placement of 7mm double bare metal stent by side by side method.
Placement of 7mm single bare metal stent by side by side method.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients diagnosed as malignant hilar biliary obstruction of Bismuth classification II or higher by histopathology or diagnostic imaging such as CT and MRI
2) Patients with obstructive jaundice (Total billirubin> 2mg / dL) due to malignant hilar biliary obstruction at the first drainage
3) Patients who are over 20 years old when obtaining consent
4) Patients who have been diagnosed as clinically non-resectable
5) Patients who are expected to survive more than 3 months
6) Patients who have obtained their written informed consent to participate in the study
1) Patients who cannot receive endoscopic treatment due to general condition, jaw, oral cavity and digestive tract condition
2) Patients who have more than ASA Classification class 4(with severe life-threatening systemic disease) poor general condition or severe complications (severe congestive heart failure, severe coronary failure)
3) Patients after reconstruction of upper gastrointestinal tract other than Billroth-I reconstruction
4) Patients after excision of the duodenal papilla, after papilloplasty, and after surgical biliary anastomosis
5) Patients who are considering radical resection, radiation therapy, particle beam therapy, photodynamic therapy, high-intensity focused ultrasound
6) Patients whose periodic replacement of PS is considered desirable
7) Patients after biliary stent placement that cannot be removed
8) Patients whose endoscopic drainage is considered to be ineffective because of severely severe biliary branching due to huge intrahepatic cholangiocarcinoma or extensive cholangiocarcinoma
9) Patients who judge that uncovered MS placement should be avoided when tumor bleeding is severe, or when it is composed of a luminal growth type papillary tumor such as IPNB.
10) Patients with uncontrolled active infection other than acute cholangitis
11) Patients with primary sclerosing cholangitis, IgG4-related cholangitis, primary biliary cholangitis
12) Patients who have difficulty in determining the yellowing effect due to severe cirrhosis
13) Patients who have high total billirubin due to hemolytic disease and may not have obstructive jaundice
14) Patients with a history of allergy to biliary contrast media and severe allergies to angiographic media
15) Patients who are pregnant or may be pregnant
16) Patients whose follow-up is considered impossible at the study participating facility or related facilities that can be in close contact
120
1st name | Atsushi |
Middle name | |
Last name | Irisawa |
Dokkyo Medical University
Department of gastroenterology
321-0293
880, Kitakobayashi, Mibu, Shimotsuma, Tochigi
0282-86-1111
irisawa@dokkyomed.ac.jp
1st name | Kouhei |
Middle name | |
Last name | Tsuchida |
Dokkyo Medical University
Department of gastroenterology
321-0293
880, Kitakobayashi, Mibu, Shimotsuma, Tochigi
0282-86-1111
tsuchida@dokkyomed.ac.jp
Dokkyo Medical University
Non
Self funding
Dokkyo Medical University
880, Kitakobayashi, Mibu, Shimotsuma, Tochigi
0282-86-1111
tsuchida@dokkyomed.ac.jp
NO
2019 | Year | 10 | Month | 01 | Day |
Unpublished
Preinitiation
2019 | Year | 09 | Month | 01 | Day |
2019 | Year | 10 | Month | 01 | Day |
2022 | Year | 07 | Month | 31 | Day |
2019 | Year | 09 | Month | 07 | Day |
2019 | Year | 09 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043253
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