UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007332 |
|---|---|
| Receipt number | R000008640 |
| Scientific Title | A retrospective study on usefulness of an endoscopic pancreatic spontaneous dislodgement stent for prophylaxis of post-ERCP pancreatitis |
| Date of disclosure of the study information | 2012/02/21 |
| Last modified on | 2012/03/28 21:37:39 |
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Basic information
Public title
A retrospective study on usefulness of an endoscopic pancreatic spontaneous dislodgement stent for prophylaxis of post-ERCP pancreatitis
Acronym
Prophylaxis of post-ERCP pancreatitis by an endoscopic pancreatic stent
Scientific Title
A retrospective study on usefulness of an endoscopic pancreatic spontaneous dislodgement stent for prophylaxis of post-ERCP pancreatitis
Scientific Title:Acronym
Prophylaxis of post-ERCP pancreatitis by an endoscopic pancreatic stent
Region
| Japan |
Condition
Condition
Post-ERCP pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this retrospective study is to elucidate the usefulness of a pancreatic stent for post-ERCP pancreatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference of frequency of post-ERCP pancreatitis between the pancreatic stent group and the non pancreatic stent group
Key secondary outcomes
Subgroup analysis of risk factors for post-ERCP pancreatitis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ERCP performed in Kobe University Hospital from April 2006 to February 2009
Key exclusion criteria
(1)patients with the past history of endoscopic sphincterotomy or papillary balloon dilatation
(2)patients who have pancreas divisum
(3)patients who have tumor of pailla vater
(4)patients who are receiving endoscopic therapy of ENPD or pancreatic stent
(5)patients with the past history of pancreaticoduodenectomy
Target sample size
1131
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromu Kutsumi |
Organization
Kobe University Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6305
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Research Committee of intractable Pancreatic Disease
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2012 | Year | 02 | Month | 21 | 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
The usefulness of a pancreatic stent in prophylaxis of post-ERCP pancreatitis was proved using a propensity score matching analysis
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
| 2010 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 01 | Month | 01 | Day |
Other
Other related information
We reviewed the medical records of 1131 ERCPs performed at Kobe University Hospital from April 2006 to February 2009, and investigated patients' clinical characteristics including the risk factors of post-ERCP pancreatitis (sphincter of Oddi dysfunction, previous pancreatitis, female gender, pre-cut sphincterotomy, pancreatic duct injection, cannulation time of more than 15 minutes, total procedure time of more than 30 minutes, procedures through pancreatic duct), the use of a pancreatic stent, and complications of ERCP. Using the propensity score for pancreatic stents, one-to-one matching was performed for the pancreatic stent group and the non pancreatic stent group. The incidence of post-ERCP pancreatitis was compared between two groups.
Management information
Registered date
| 2012 | Year | 02 | Month | 20 | Day |
Last modified on
| 2012 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008640
