Effects of Dexamethasone on Common Bile Duct Cannulation Time

Sponsor
Gujranwala medical college District Headquarters Hospital, Gujranwala (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05945797
Collaborator
(none)
80
2
4

Study Details

Study Description

Brief Summary

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Can Deep Common Bile Duct Cannulation Time During Endoscopic Retrograde Cholangiopancreatography be Shortened by Dexamethasone
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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.]

      To determine the effects of dexamethasone on shortening of CBD cannulation time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Gujranwala medical college District Headquarters Hospital, Gujranwala

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gujranwala medical college District Headquarters Hospital, Gujranwala
    ClinicalTrials.gov Identifier:
    NCT05945797
    Other Study ID Numbers:
    • 001
    First Posted:
    Jul 14, 2023
    Last Update Posted:
    Jul 14, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gujranwala medical college District Headquarters Hospital, Gujranwala
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 14, 2023