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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004324
Receipt No. 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

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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 &#8805; 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&#8211;IDUS), 12) difficulty of cannulation ( &#8805; 15 minutes), and 13) procedure time ( &#8805; 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
Email

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
Email a-sofuni@amy.hi-ho.ne.jp

Sponsor
Institute Japan Pancreatic Stent-Study Group (JPS-SG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001482

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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