Effect of ice water injection toward the duodenal papilla for preventing post-ERCP pancreatitis: a multicenter, single-blinded, randomised controlled trial.
Not Applicable
- Conditions
- pancreaticobiliary disease
- Registration Number
- JPRN-UMIN000047528
- Lead Sponsor
- Kitano Hospital, Tazuke Kofukai Medical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 880
Inclusion Criteria
Not provided
Exclusion Criteria
(1) evaluated 4 levels according to the Eastern Cooperative Oncology Group Performance Status (2) age younger than 20 years (3) not native papilla (4) those cases that were expected to have duodenal papilla that were inaccessible by endoscopy (5) case of post gastrectomy (excluding B-I reconstruction) (6)presence of acute pancreatitis (7) presence of chronic pancreatitis (8) presence of pancreatic head cancer with occlusion of the main pancreatic duct (9)inability to provide written informed consent (10)subjects deemed inappropriate for the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PEP incidence
- Secondary Outcome Measures
Name Time Method (1) Incidence of PEP in patients with difficult bile duct or pancreatic duct intubation, (2) Incidence of PEP by various ERCP procedures (bile duct purpose, pancreatic duct purpose, EST, EPBD, biopsy, IDUS, bile duct stenting, etc.), (3) Incidence of PEP by presence or absence of pancreatic duct cannulation or pancreatography, (4) Incidence of PEP by cannulation time, ( (5) Severity of PEP, (6) Incidence of PEP by high risk factors for PEP, (7) Incidence of other complications