UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031972 |
|---|---|
| Receipt number | R000036498 |
| Scientific Title | Phase II study on prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis by placement of 4Fr prophylactic pancreatic duct stent in patients who is performed endoscopic pancreatic duct injection (multicenter study) |
| Date of disclosure of the study information | 2018/03/29 |
| Last modified on | 2024/01/10 18:44:03 |
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Basic information
Public title
Phase II study on prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis by placement of 4Fr prophylactic pancreatic duct stent in patients who is performed endoscopic pancreatic duct injection (multicenter study)
Acronym
prevention of post-ERCP pancreatitis by placement of 4Fr prophylactic pancreatic duct stent
Scientific Title
Phase II study on prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis by placement of 4Fr prophylactic pancreatic duct stent in patients who is performed endoscopic pancreatic duct injection (multicenter study)
Scientific Title:Acronym
prevention of post-ERCP pancreatitis by placement of 4Fr prophylactic pancreatic duct stent
Region
| Japan |
Condition
Condition
biliary duct disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of post-endoscopic retrograde cholangiopancreatography pancreatitis by 4Fr prophylactic pancreatic stent placement for patient who is performed endoscopic pancreatic duct injection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frquency of post-endoscopic retrograde cholangiopancreatography pancreatitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
4Fr placement of prophylatic pancreatic duct 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
.native papilla
.patient who is performed endoscopic retrograde cholangiography purposes only in the biliary duct
Key exclusion criteria
.acute pancreatitis
.postoperative reconstructed intestinal tract (Billroth ii, Roux-en-Y method)
.patient with serious systemic illness, dangerous condition of life
.intraductal papillary mucinous neoplasm
.complete obstruction of main pancreatic duct
.patient who already registered in this study once
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
6410012
Address
811-1, Kimiidera, Wakayama city, Wakayama
TEL
073-447-2300
ttakashi@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Tamura |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
6410012
Address
811-1, Kimiidera, Wakayama city, Wakayama
TEL
073-447-2300
Homepage URL
ttakashi@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Reveiw Comittee of Wakayama Medical University
Address
811-1 Kimidera Wakayama-shi
Tel
0734410714
wa-riniri@wakayama-med.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
| 2018 | Year | 03 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 24 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 24 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036498
