UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054798 |
|---|---|
| Receipt number | R000062611 |
| Scientific Title | Prospective single-arm study on efficacy of transpapillary biliary drainage using 12-Fr plastic stent for distal biliary strictures due to pancreatic cancer requiring preoperative chemotherapy |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/12/20 14:04:47 |
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Basic information
Public title
Prospective single-arm study on efficacy of transpapillary biliary drainage using 12-Fr plastic stent for distal biliary strictures due to pancreatic cancer requiring preoperative chemotherapy
Acronym
Prospective single-arm study on efficacy of transpapillary biliary drainage using 12-Fr plastic stent for distal biliary strictures due to pancreatic cancer requiring preoperative chemotherapy
Scientific Title
Prospective single-arm study on efficacy of transpapillary biliary drainage using 12-Fr plastic stent for distal biliary strictures due to pancreatic cancer requiring preoperative chemotherapy
Scientific Title:Acronym
Progress 12 Study
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of transpapillary biliary drainage using 12-Fr plastic stent for distal biliary strictures due to resectable or borderline resectable pancreatic cancer requiring preoperative chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrent biliary obstruction (RBO) rate in the observation period
observation period: from the date of biliary drainage to the earliest date of surgery, the decision not to resect pancreatic cancer, or 1 year after biliary drainage.
Key secondary outcomes
technical success rate, clinical success rate, rate of adverse events related to endoscopic procedures, time to surgical operation, time to recurrent biliary obstruction (TRBO).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Endoscopic transpapillary biliary drainage using 12-Fr plastic stent.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a. Those who have been diagnosed as resectable or borderline resectable pancreatic cancer by blood test, imaging or histology.
b. Those who need biliary drainage* before preoperative chemotherapy
* Total bilirubin =/> 2.0mg/dL or AST =/> 100U/L.
c. Those who are planned to receive preoperative chemotherapy after biliary drainage.
d. No history of previous biliary stent placement.
e. Obtaining written informed consent
Key exclusion criteria
a. No tolerance of endoscopic procedures
b. ASA class 4 or more
c. Post-gastrectomy reconstruction using methods other than Billroth I
d. Not intended to receive preoperative chemotherapy
e. History of percutaneous transhepatic biliary drainage or endoscopic ultrasound-guided biliary drainage
f. Duodenal stenosis is suspected on specific symptoms or imaging studies
g. Age < 18 years
h. Already enrolled in this clinical trial
i. Allergic for contrast
j. Pregnancy
k. Difficult to follow up
l. Judged to be ineligible by investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidehito |
| Middle name | |
| Last name | Sumiya |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
TEL
022-252-1111
hsumiya@openhp.or.jp
Public contact
Name of contact person
| 1st name | Hidehito |
| Middle name | |
| Last name | Sumiya |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
TEL
022-252-1111
Homepage URL
hsumiya@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
Sendai City Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Sendai City Medical Center
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
Tel
022-252-1111
hsumiya@openhp.or.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
| 2024 | Year | 08 | Month | 01 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2024 | Year | 06 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062611
