UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021260 |
|---|---|
| Receipt number | R000024084 |
| Scientific Title | Modified fully covered self-expandable metallic versus multiple plastic stents for refractory benign pancreatic ductal strictures in chronic pancreatitis: A prospective, multi-center, randomized study |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2016/03/04 17:56:56 |
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Basic information
Public title
Modified fully covered self-expandable metallic versus multiple plastic stents for refractory benign pancreatic ductal strictures in chronic pancreatitis: A prospective, multi-center, randomized study
Acronym
Metallic vs multiple plastic stents for benign pancreatic strictures
Scientific Title
Modified fully covered self-expandable metallic versus multiple plastic stents for refractory benign pancreatic ductal strictures in chronic pancreatitis: A prospective, multi-center, randomized study
Scientific Title:Acronym
Metallic vs multiple plastic stents for benign pancreatic strictures
Region
| Asia(except Japan) |
Condition
Condition
Chronic pancreatitis
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to compare the efficacy of fully covered self-expandable metallic stent and multiple plastic stents for refractory benign pancreatic ductal stricture in patients with chronic pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resolution of pancreatic ductal stricture along with a decrease in upstream duct diameter on a pancreatogram after stent removal and complete runoff of contrast
Key secondary outcomes
Early and late complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Multiple plastic stenting for 3 months
Interventions/Control_2
Metal stenting for 3 months
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Imaging findings compatable with chronic pancreatitis
2. Benign pancreatic stricture with upstream pancreatic duct dilation and abdominal pain
3. Refractory or recurrent stricture to single plastic stenting
Key exclusion criteria
1. Contraindications to ERCP
2. Multiple pancreatic strictures
3. Bleeding tendency
4. Women in pregnancy
5. Refusal to study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jong Ho Moon |
Organization
SoonChunHyang University School of Medicine
Division name
Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address
170 Jomaru-ro, Wonmi-gu, Bucheon 14584
TEL
+82-32-621-5094
jhmoon@schmc.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hyun Jong Choi |
Organization
SoonChunHyang University School of Medicine
Division name
Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address
170 Jomaru-ro, Wonmi-gu, Bucheon 14584
TEL
+82-32-621-5211
Homepage URL
joseph@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No specific funding source
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 01 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024084
| Research Plan | |
|---|---|
| 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 |
