UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004324 |
|---|---|
| Receipt number | R000001482 |
| Scientific Title | Effectiveness of prophylaxis of post-ERCP pancreatitis for risk group by an endoscopic pancreatic spontaneous dislodgement stent -randomized controlled multicenter trial- |
| Date of disclosure of the study information | 2010/10/04 |
| Last modified on | 2010/10/04 23:31:53 |
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Basic information
Public title
Effectiveness of prophylaxis of post-ERCP pancreatitis for risk group by an endoscopic pancreatic spontaneous dislodgement stent
-randomized controlled multicenter trial-
Acronym
Effectiveness of prophylaxis of post-ERCP pancreatitis by pancreatic spontaneous dislodgement stent-randomized controlled multicenter trial-
Scientific Title
Effectiveness of prophylaxis of post-ERCP pancreatitis for risk group by an endoscopic pancreatic spontaneous dislodgement stent
-randomized controlled multicenter trial-
Scientific Title:Acronym
Effectiveness of prophylaxis of post-ERCP pancreatitis by pancreatic spontaneous dislodgement stent-randomized controlled multicenter trial-
Region
| Japan |
Condition
Condition
Effectiveness of prophylaxis of post-ERCP pancreatitis for risk group by an endoscopic pancreatic spontaneous dislodgement stent
-randomized controlled multicenter trial-
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conducted a randomized controlled trial (RCT) to evaluate whether placement of a spontaneous dislodgement-type pancreatic duct stent would prevent pancreatitis after ERCP-related procedures in patients with risk factors of post ERCP-pancreatitis(PEP), and to identify risk factors of PEP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The primary study endpoints were the frequency and severity of post-ERCP pancreatitis in patients with risk factors. We also evaluated hyperamylasemia, the success rate of stent placement, the duration before stent dislodgment, and complications in both groups. We also evaluated risk factors for post-ERCP pancreatitis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
P-stent
Interventions/Control_2
non P-stent
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Risk factors were divided into two groups: a) patient-related factors and b) procedure-related factors. Patient-related factors included: 1) age < 60, female gender, 2) history of pancreatitis, and 3) suspected biliary sphincter of Oddi disorder (SOD). Procedure-related factors included: 1) pancreatography first, 2) pancreatography ≥ 2 times, 3) endoscopic pancreatic sphincterotomy (EPST), 4) precut, 5) endoscopic papillary balloon dilation (EPBD), 6) common bile duct (C) -tissue sampling (biopsy, brush, cytology), 7) pancreatic duct (P) -tissue sampling (biopsy, brush, cytology), 8) non-endoscopic sphincterotomy (ES) + endoscopic biliary drainage (EBD), 9) non ES + endoscopic nasobiliary drainage (ENBD), 10) common bile duct intraductal ultrasonography (C-IDUS), 11) pancreatic duct-intraductal ultrasonography (P–IDUS), 12) difficulty of cannulation ( ≥ 15 minutes), and 13) procedure time ( ≥ 30 minutes ) (Figure 2).
Key exclusion criteria
The following cases were excluded: 1) cases who could not provide written informed consent, 2) cases deemed inappropriate for this trial (although there were none in the present study), 3) cases with a performance status of 4, 4) cases in which the duodenal papilla could not be accessed endoscopically, 5) cases requiring pancreatic duct drainage, 6) cases with a history of prior ERCP procedures, 7) cases of postgastrectomy, 8) cases requiring endoscopic papillectomy, 9) cases of pancreatic head cancer with main pancreatic duct occlusion, 10) cases of pancreas divisum (excluding such cases at the stage when diagnosed by ERCP, due to the difficulty of diagnosis before pre-ERCP), 11) cases of chronic pancreatitis, 12) cases of intraductal papillary mucinous neoplasms (IPMN), 13) cases of gallstone pancreatitis, 14) cases of pancreaticobiliary maljunction, and 15) cases in which the ERCP procedure was not completed within 1 hour from the transoral insertion of the scope.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Sofuni |
Organization
Tokyo Medical University
Division name
Gastroenterology and hepatology
Zip code
Address
Nishishinjuku 6-7-1 Shinjyuku-ku Tokyo Japan
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Medical University
Division name
Gastroenterology and hepatology
Zip code
Address
TEL
Homepage URL
a-sofuni@amy.hi-ho.ne.jp
Sponsor or person
Institute
Japan Pancreatic Stent-Study Group (JPS-SG)
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
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 | 10 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 04 | Day |
Last modified on
| 2010 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001482
