UMIN-CTR Clinical Trial

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

post ERCP pancreatitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Miyazaki University School of Medicine

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

2009

Year

11

Month

13

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

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 related information

Registered date

2009

Year

11

Month

13

Day

Last modified on

2011

Year

05

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003357