Effects of Dexamethasone on Common Bile Duct Cannulation Time

March 18, 2025 updated by: Gujranwala medical college District Headquarters Hospital, Gujranwala

Can Deep Common Bile Duct Cannulation Time During Endoscopic Retrograde Cholangiopancreatography Be Shortened by Dexamethasone

The main aim of this clinical trial is to evaluate the effects of dexamethasone on common bile duct cannulation time during endoscopic retrograde cholangiopancreatography (ERCP) in patients with biliary pathologies. The study will also study the effects of dexamethasone on total procedure time and total fluoroscopy time during ERCP.

Participants will be divided into two groups, treatment group and placebo group. Patients in treatment group will receive dexamethasone and those in placebo group will be given normal saline before undergoing ERCP. The results in both groups will be compared to determine the effects of dexamethasone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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 Locations

  • Pakistan
    • Punjab
      • Gujranwala, Punjab, Pakistan, 52070
        • Gujranwala Medical College Hospital

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:

  • Age: 18 years or above
  • Both genders, male and female patients

Exclusion Criteria:

  • Age younger than 18 years or below
  • Pregnant females
  • Pre existing stent in CBD or pancreatic duct
  • Previous history of ERCP
  • Patients with billroth II surgery
  • Anatomical abnormalities
  • Lack of competence in patients
  • Roux en Y gastric bypass
  • Patients with contra indications for steroids like DM

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexa Arm
Experimental arm patients will be receiving 2 ml (4mg) of dexamenthasone prior to undergoing ERCP.
Drug: Dexamethasone 4mg
An injection of 4mg of dexamethasone will be given to patients approximately 2 to 4 hours prior to the procedure of ERCP.
Other Names:
  • steroids
Placebo Comparator: NS Arm
Placebo arm patients will be receiving 2 ml of normal saline prior to undergoing ERCP.
Drug: Dexamethasone 4mg
An injection of 4mg of dexamethasone will be given to patients approximately 2 to 4 hours prior to the procedure of ERCP.
Other Names:
  • steroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shortening of CBD cannulation time
Time Frame: CBD cannulation time will be calculated from the start of the procedure (0 minutes) till complete CBD cannulation has been achieved through catheter and confirmed by fluoroscopy or procedure abandoned if unsuccessful cannulation by 30 minutes.
To determine the effects of dexamethasone on shortening of CBD cannulation time
CBD cannulation time will be calculated from the start of the procedure (0 minutes) till complete CBD cannulation has been achieved through catheter and confirmed by fluoroscopy or procedure abandoned if unsuccessful cannulation by 30 minutes.

Collaborators and Investigators

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

Sponsor

Gujranwala medical college District Headquarters Hospital, Gujranwala

Investigators

  • Study Chair: Najam us Sehar Saeed, FCPS-Gastro, GMC-DHQ Hospital, Gujwanala, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 1, 2023

Primary Completion (Actual)

April 12, 2024

Study Completion (Actual)

May 16, 2024

Study Registration Dates

First Submitted

June 11, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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