MedPath

Efficacy and safety of primary Needle Knife Fistulotomy in patients undergoing ERCP with a long papilla

Not Applicable
Conditions
bile duct disorder.
Obstruction of bile duct
K83.1
Registration Number
IRCT20221026056313N1
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
181
Inclusion Criteria

People over 18 years old
Patients with acute pancreatitis
Patients with gallstones
ultrasound findings (CBD dilatation) that indicate CBD stone and CBD obstruction.

Exclusion Criteria

Age less than 18 years
pregnancy
Contrast sensitivity
History of previous sphincterectomy
Refusal to give informed written consent
Gastrojejunostomy
Patients with severe coagulopathy

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Success rate of bile duct cannulation. Timepoint: At the time of cannulation by the endoscopist. Method of measurement: Visual diagnosis of the endoscopist by observing the cannulation process on the monitor.;Post ERCP complication. Timepoint: During or after the procedure. Method of measurement: Clinical evidence and laboratory tests of bleeding, perforation, pancreatitis.
Secondary Outcome Measures
NameTimeMethod
Body temperature. Timepoint: 4 hours after the completion of the procedure. Method of measurement: thermometer.;Amylas. Timepoint: before the procedure and 3 hours after the procedure. Method of measurement: blood test for investigation of Amylas level.;Lipas. Timepoint: before the procedure and 3 hours after the procedure. Method of measurement: blood test for investigation of lipas level.
© Copyright 2025. All Rights Reserved by MedPath