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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002762
Receipt No. R000003357
Scientific Title Randamized Controlled Trial for Effect of Nafamostat Mesilate in Prevention of post-ERCP Pancreatitis
Date of disclosure of the study information 2009/11/13
Last modified on 2011/05/13

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Basic information
Public title Randamized Controlled Trial for Effect of Nafamostat Mesilate in Prevention of post-ERCP Pancreatitis
Acronym Effect of Nafamostat Mesilate in Prevention of post-ERCP Pancreatitis
Scientific Title Randamized Controlled Trial for Effect of Nafamostat Mesilate in Prevention of post-ERCP Pancreatitis
Scientific Title:Acronym Effect of Nafamostat Mesilate in Prevention of post-ERCP Pancreatitis
Region
Japan

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

Objectives
Narrative objectives1 Endoscopic Retrograde Cholangio Pancreatography (ERCP) is recognized as an indispensable method to diagnose and treat cholangio-pancreatic diseases, however, from another aspect, its significance has been decreasing along with recent progress in development of non-invasive medical devises which is used for imaging diagnosis. Although ERCP still plays an important role in treating cholangio- pancreatic diseases. In cases where complete resection is required, use of ERCP before surgery is significantly important to give precise determination of the area for resection. Also ERCP is an important method to conduct cytology and biopsy to confirm final diagnosis. ERCP is often causes incidental symptoms and its incidence is higher compared to other endoscopic methods. One of severe symptoms is pancreatitis, in which serious cases may sometimes lead to death. Incidence rate of post-ERCP pancreatitis varies depending on subjects population and examination method applied, it is reportedly said the incidence is around 2~10% according to recently conducted survey. Although many trials and reviews have been conducted in the attempt to reduce and to prevent pancreatitis, definite solution has not been found until today. Mechanism of action of post-ERCP pancreatitis is yet to be elucidated, there are several speculations for the causes; increase in pancreatic inner pressure due to frequent pancreatography, acinar injury due to parenchymal of pancreas, papillary edema and contraction caused by mechanical stimulation, and transient interference in reflux of pancreatic juice as those results. In clinical practice, protease inhibitors are generally administered for the treatment of acute pancreatitis, however, only a few randomized controlled trials have been conducted with respect to preventive effect of these drugs in post- ERCP pancreatitis. This trial is to examine efficacy and safety of nafamostat mesilate on its preventive use in post-ERCP pancreatitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Incidence rate of post-ERCP pancreatitis
Post-ERCP pancreatitis is defined according to Consensus Guideline (by Cotton Classification) published in 1991 as (1) Pancreatic pain which is sustained for more than 24 hours and (2) Serum pancreatic enzyme level is three-times higher than normal at 18 hour after ERCP. However, those cases where pancreatic pain and increase in serum pancreatic enzyme are observed even at 4 hours of examination are regarded as suspected post-ERCP pancreatitis and treatment is started. The case where serum pancreatic enzyme is over normal range but there is no pancreatic symptoms is regarded as the pancreatic enzyme level being three-times higher than pre-level.
Key secondary outcomes Change in serum amylase and lipase
These parameters are measured before, 4 hours after ERCP, and the following morning.
Incidence rate of pancreatitis not due to ERCP

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 After obtaining consent by subjects in participating the study, treatment is decided by envelope method. Drug-treatment group is administered with 20mg nafamostat mesilate in 500ml of 5% glucose solution at start of ERCP for two hours.
Interventions/Control_2 After obtaining consent by subjects in participating the study, treatment is decided by envelope method. Placebo-group is administered with 500ml of 5% glucose solution at start of ERCP for two hours.
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 suffers from cholandio-pancreatic diseases and endoscopic examination is due. Informed consent by patient is voluntarily obtained.
Key exclusion criteria Exclusion Criteria
Patients with acute pancreatitis, acute exacerbation of chronic pancreatitis,
Young children
Patients who does not give consent to the study
Patients who have hypersensitivity to nafamostat mesilate
Patients with serious heart diseases, Patients with diabetes mellitus
Patients who are judged inappropriate by chief (responsive) medical examiner
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jiro Ohuchida
Organization Miyazaki University School of Medicine
Division name Department of Surgical Oncology and Regulation of Organ Function
Zip code
Address 5200 Kihara, Kiyotakecho, Miyazaki-gun, Miyazaki
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jiro Ohuchida
Organization Miyazaki University School of Medicine
Division name Department of Surgical Oncology and Regulation of Organ Function
Zip code
Address 5200 Kihara, Kiyotakecho, Miyazaki-gun, Miyazaki
TEL 0985-85-9284
Homepage URL
Email jirooh@med.miyazaki-u.ac.jp

Sponsor
Institute Miyazaki University School of Medicine
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
2009 Year 11 Month 13 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
2008 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 13 Day
Last modified on
2011 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003357

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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