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

Efficacy and safety of primary Needle Knife Fistulotomy in patients undergoing ERCP with a long papilla: A single blind randomized prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221026056313N1
Enrollment
181
Registered
2023-07-24
Start date
2023-08-06
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

bile duct disorder. Obstruction of bile duct

Interventions

Intervention 1: Intervention group: Intervention group: In the first group, the bile ducts of the patients will be cannulated with a standard technique. In this technique, the guidewire enters the bil

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrnoosh alizadeh

Shahid Beheshti University of Medical Sciences

mehrnoosh_alizadeh@yahoo.com+98 21 2243 2560

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026