UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041597 |
|---|---|
| Receipt number | R000047057 |
| Scientific Title | Randomized phase III Study of 10 mm and 12 mm Diameter Metal Stents for pancreatic cancer with unresectable malignant obstruction of the distal biliary tract |
| Date of disclosure of the study information | 2020/08/28 |
| Last modified on | 2024/03/01 09:58:38 |
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Basic information
Public title
Randomized phase III Study of 10 mm and 12 mm Diameter Metal Stents for pancreatic cancer with unresectable malignant obstruction of the distal biliary tract
Acronym
Randomized phase III Study of 10 mm and 12 mm Diameter Metal Stents for pancreatic cancer with unresectable malignant obstruction of the distal biliary tract
Scientific Title
Randomized phase III Study of 10 mm and 12 mm Diameter Metal Stents for pancreatic cancer with unresectable malignant obstruction of the distal biliary tract
Scientific Title:Acronym
Randomized phase III Study of 10 mm and 12 mm Diameter Metal Stents for pancreatic cancer with unresectable malignant obstruction of the distal biliary tract
Region
| Japan |
Condition
Condition
pancreatic cancer with unresectable malignant obstruction of the distal biliary tract
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Confirming the superiority of the 12 mm diameter bile duct metal stent for face loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patency of the 12mm-diameter metal stent.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
12mm-diameter stent placement
Interventions/Control_2
10mm-diameter stent placement
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Cases with jaundice or hepatic dysfunction. Jaundice has a serum total bilirubin level of 3.0 mg/dl or more, and liver dysfunction is blood transaminase, ALP, or GTP.
(2) Patients with malignant histopathological confirmation.
(3)Unresectable is confirmed by diagnostic imaging or patient background factors.
(4)Expanded bile duct diameter is 12 mm or more by image diagnosis when confirming obstructive jaundice or liver function abnormality
(5)Biliary stricture exists in the middle and lower parts that do not reach the hilum of the liver
(6)Patients with ECOG Performance Status 0 or 1.
(7)Expected survival time of 4 months or more
(8)The age at the time of obtaining consent is 20 or more and less than 80.
Key exclusion criteria
(1) Reconstruction methods other than Billoth-I reconstruction are used after gastrectomy.
(2) Patients with obstruction of the anus from the duodenal papilla.
(3) Patients who had a metal stent in the past.
(4) Cases with serious complications in other organs (ASA classification 3 or higher.)
(5) Patients with acute pancreatitis and acute exacerbation of chronic pancreatitis.
(6) Patients with cirrhosis (Child-Pugh Grade B or C)
(7) Platelet count is 50,000/mm3 or less according to the latest test value within 28 days before registration.
(8) In addition, patients who are judged by the attending physician to be inappropriate for conducting this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Gastroenterological Oncology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81-562-93-2324
yoshiki.hirooka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Nakaoka |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Gastroenterological Oncology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81-562-93-2324
Homepage URL
knakaoka@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Univercity
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
Tel
0562932865
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 1980 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047057
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
