UMIN-CTR Clinical Trial

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

protection of post ERCP pancreatitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Faculty of Medicine, University of Tokyo

Institute

Department

Personal name

Organization

nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2006

Year

10

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2006

Year

10

Month

27

Day

Last modified on

2009

Year

10

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000610