Randamized Controlled Trial for Effect of Nafamostat Mesilate in Prevention of post-ERCP Pancreatitis

Randamized Controlled Trial for Effect of Nafamostat Mesilate in Prevention of post-ERCP Pancreatitis - Effect of Nafamostat Mesilate in Prevention of post-ERCP Pancreatitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002762

Enrollment

600

Registered

2009-11-13

Start date

2008-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post ERCP pancreatitis

Interventions

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 solut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who suffers from cholandio-pancreatic diseases and endoscopic examination is due. Informed consent by patient is voluntarily obtained.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactJiro Ohuchida

Miyazaki University School of Medicine Department of Surgical Oncology and Regulation of Organ Function

jirooh@med.miyazaki-u.ac.jp0985-85-9284

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026