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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000505
Receipt No. R000000610
Scientific Title Multicenter, randomized trial for protection of post ERCP pancreatitis with/without Risperidone(Tokyo P3R)
Date of disclosure of the study information 2006/10/27
Last modified on 2009/10/01

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Basic information
Public title Multicenter, randomized trial for protection of post ERCP pancreatitis with/without Risperidone(Tokyo P3R)
Acronym Tokyo P3R
Scientific Title Multicenter, randomized trial for protection of post ERCP pancreatitis with/without Risperidone(Tokyo P3R)
Scientific Title:Acronym Tokyo P3R
Region
Japan

Condition
Condition protection of post ERCP pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is perceived as a cause of Post-ERCP pancreatitis, that self-digestion in the pancreas by regurgitation of pancreatic enzyme owing to increased pancreatic duct pressure after injection of contrast dye or temporary blockage the opening of the pancreatic duct. Bat the occurrence mechanism is less well understood, especially how pancreatic enzyme that are secreted in an inactive form are activated. Steer and Mendolesi (1987)hypothecated in accordance with the result of the animal study, that imbalance between synthesis and secretoryo cause accumulation in cell of enzyme and the enzyme are activated in the process of clearance by lysosome. It's noted that the mechanical/ chemical stimulus of ERCP in gastroduodenal mucosa promote pancreatic secretion through serotonin(5-HT)release from Enterochromaffin cells, and 5-HT2 receptor antagonist prevents pancreatitis. Additionally, activation of 5-HT2A receptor out of the 5-HT2 receptor subtype(5-HT2A/2B/2C)cause the development of a high rate of mortality, serum amylase and lipase level in pancreatitis model mice, and suggest the effect of 5-HT2A receptor-selective antagonist as a possible exceeds of existing proteolytic enzyme inactivator these days. Risperidone is described as serotonin-dopamine antagonist(SDA)at the pharmacological feature. The drug has high specificity for 5-HT2A receptor out of the 5-HT2 receptor, and in pancreatitis model , it has thick action to reduce morbidity, elevation in serum amylase and lipase level. This drug is used as schizophrenic disorder and other psychotic symptom, and safety and efficacy on these disorders are already established .This study intended that we explore the efficacy and safety of risperidone for protection of post ERCP pancreatitis was used together with protease inhibitor(urinastatin).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Percentage of post ERCP pancreatitis patient.The standard basis for diagnostic criterion of post ERCP pancreatitis are as follows. Over three times more than exceed the serum amylase level limit after 18hours post ERCP.Epigastric pain of more than 24 hours.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Observations of patient is conducted between 24 hours before ERCP and the start of manipulation . Risperidone is administered between 2 and 0.5 hours before ERCP in group of Risperidone.Urinastatin at dose of 150000 units
is administered 10 minutes before ERCP .Observations of patient is conducted 3,18 hours after ERCP.And 48 hours as needed.
Interventions/Control_2 Observations of patient is conducted between 24 hours before ERCP and the start of manipulation.Urinastatin at dose of 150000 units
is administered 10 minutes before ERCP in Urinastatin groups.Observations of patient is conducted 3,18 hours after ERCP.And 48 hours as needed.
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
76 years-old >
Gender Male and Female
Key inclusion criteria Patients who are planned ERCP.Patients who fully understand and are willing to give a written informed consent about participation.circulatory failure.
Key exclusion criteria Patients with a history of Endoscopic sphincterotomy.
Patients have acute pancreatitis or acute exacerbation of chronic pancreatitis need the fasting therapy.
Patients have disseminated intravascular coagulation,sepsis,acute.
Patients have severe disturbance of consciousness than Japan Coma Scale1-1.
Patients have severeheart disease,hepatic insufficiency,compromised renal function,endocrine disease,and gastrointestinal tract disturbance.
Pregnant and breast-feeding women or women suspected of being pregnant,women are not willing to avoid pregnancy during the duration of study .
Patients on Risperidone.
Patients with a history of severe hypersensitivity to the Risperidone and Urinastatin.
Patients have mental illness or depression who need continued medication or can not comply with the protocol.
Patients with Parkinson's disease or parkinsonism.
Patients receiving banned drug within 2 weeks before pre-observations.
Patients with a history of enrolled in this clinical trial.
Somebody who are found unfit to be patients by investigator.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization Faculty of Medicine, University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Isayama
Organization Faculty of Medicine, University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Faculty of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Self funding
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
2006 Year 10 Month 27 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
2006 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 04 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2009 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 10 Month 27 Day
Last modified on
2009 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000610

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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