UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021403 |
|---|---|
| Receipt number | R000024537 |
| Scientific Title | A multicenter prospective study to compare outcomes of endoscopic and surgical interventions for chronic pancreatitis-induced pain |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2024/09/18 00:00:24 |
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Basic information
Public title
A multicenter prospective study to compare outcomes of endoscopic and surgical interventions for chronic pancreatitis-induced pain
Acronym
A multicenter prospective study to compare outcomes of endoscopic and surgical interventions for chronic pancreatitis-induced pain
Scientific Title
A multicenter prospective study to compare outcomes of endoscopic and surgical interventions for chronic pancreatitis-induced pain
Scientific Title:Acronym
A multicenter prospective study to compare outcomes of endoscopic and surgical interventions for chronic pancreatitis-induced pain
Region
| Japan |
Condition
Condition
chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This multicenter prospective study aims to compare endoscopic and surgical interventions for pain relief in patients with chronic pancreatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical outcomes one year after endoscopic or surgical intervention for pain relief
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. definite diagnosis of chronic pancreatitis
2. patients who are going to undergo endoscopic and/or surgical interventions.
3. written informed consent
Key exclusion criteria
1. patients who are going to undergo only psueudocyst drainage
2. patients who had undergone pancreatic resection.
3. patients diagnosed with pancreatic cancer or suspected of having pancreatic cancer.
4. patients who had undergone endoscopic interventions within one year
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama Medical University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama, JAPAN
TEL
073-447-2300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Minaga |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL
072-366-0221
Homepage URL
cpstudy@med.kindai.ac.jp
Sponsor or person
Institute
english
Institute
Department
Personal name
Funding Source
Organization
english
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
Institutional Review Board of Kindai University Hospital
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, Japan
Tel
072-366-0221
zizen@med.kindai.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
| 2016 | Year | 04 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ee
Management information
Registered date
| 2016 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024537
