Determinants of Technical Success and Safety in Therapeutic ERCP for Obstructive Jaundice (ERCP)

April 25, 2026 updated by: Mohamed Khaled Abdelazim, Sohag University

Determinants of Technical Success and Safety in Therapeutic ERCP for Obstructive Jaundice: A Prospective Comparative Study.

compare the impact of type of anesthesia on ERCP including technical success, rate of complications, peri procedural safety, patient and endoscopist satisfaction in adult patients with obstructive jaundice

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients above 18 years old.
  • Patient with obstructive jaundice as an indication for therapeutic ERCP.
  • Provided written informed consent.

Exclusion Criteria:

  • Patients below 18 years old.
  • Indications for ERCP other than obstructive jaundice.
  • with coagulopathy not corrected prior to procedure.
  • severe active cardiopulmonary comorbidities.
  • Previous altered upper GIT anatomy (e.g gastric by-pass).
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
50 patient will under go procedure (ERCP) under general anesthesia (25 calcular obstructive jaundice ,25 malignant obstructive jaundice)
Procedure: ERCP
Effect of anesthesia on Therapeutic ERCP in patients obstructive jaundice
Experimental: Group B
50 patient will under go procedure (ERCP)under sedation (25 calcular obstructive jaundice, 25 malignant obstructive jaundice)
Procedure: ERCP
Effect of anesthesia on Therapeutic ERCP in patients obstructive jaundice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of type of anesthesia on technical success rate
Time Frame: at the time of the procedure
Technical success rate defined as successful deep biliary cannulation and completion of the intended therapeutic intervention.
at the time of the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of procedure related complications
Time Frame: at the time of procedure up to 72 hours post procedure
Procedure related complication exclusively (post ERCP pancreatitis (based on revised Atlanta criteria), bleeding, perforation, cholangitis and aspiration pneumonia)
at the time of procedure up to 72 hours post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Mohamed Khaled Abd El-Azeem, Tropical medicine and Gastroentrology department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2026

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

May 20, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 25, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 25, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-4-3MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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