UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003995 |
|---|---|
| Receipt number | R000004806 |
| Scientific Title | A Prospective Randomized Trial of Pancreatic Spontaneous Dislodgement Stents to Prevent Acute Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis |
| Date of disclosure of the study information | 2010/08/05 |
| Last modified on | 2010/08/04 12:42:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Prospective Randomized Trial of Pancreatic Spontaneous Dislodgement Stents to Prevent Acute Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Acronym
A Prospective Randomized Trial of Pancreatic Spontaneous Dislodgement Stents to Prevent Acute Post-ERCP Pancreatitis
Scientific Title
A Prospective Randomized Trial of Pancreatic Spontaneous Dislodgement Stents to Prevent Acute Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Scientific Title:Acronym
A Prospective Randomized Trial of Pancreatic Spontaneous Dislodgement Stents to Prevent Acute Post-ERCP Pancreatitis
Region
| Japan |
Condition
Condition
Post-ERCP Pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are conducting a prospective trial to evaluate efficacy, spontaneous dislodgement and complication for spontaneous dislodgement stents (Geenen pancreatic stent, Cook) with 3cm length and 5Fr diameter in high-risk patients for post-ERCP pancreatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary study endopoints were the frequency and severity of post-ERCP pancreatitis.
Key secondary outcomes
Further we evaluated hyperamylasemia, the success rate of stent placement, the duration of stent dislodgment and other complications in both groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
stent group
Interventions/Control_2
no stent group
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
The study group consisted of patients at high risk for post-ERCP pancreatitis because of previous post-ERCP pancreatitis, sphincter of Oddi dysfunction (SOD), a difficult cannulation, the performance of pre-cut, pancreatic duct biopsy or IDUS, and a case requiring greater than 30 minutes in total examination.
Key exclusion criteria
We excluded younger patients than 20 years old and patients with pancreatitis due to gall stone.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Mine |
Organization
Tokai University School of Medicine
Division name
Gastroenterology
Zip code
Address
143 Shimokasuya, Isehara
TEL
0463-93-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kawaguchi |
Organization
Tokai University School of Medicine
Division name
Gastroenterology
Zip code
Address
143 Shimokasuya, Isehara
TEL
0463-93-1121
Homepage URL
y711kawa@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2010 | Year | 08 | Month | 05 | 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
Completed
Date of protocol fixation
| 2007 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | 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
| 2010 | Year | 08 | Month | 04 | Day |
Last modified on
| 2010 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004806
