Effects of Dexamethasone on Common Bile Duct Cannulation Time

Not Applicable

Recruiting

• Conditions: Common Bile Duct Neoplasms; Common Bile Duct Stricture; Common Bile Duct Diseases; Common Bile Duct Dilatation; Common Bile Duct Calculi
• Interventions: Drug: Dexamethasone 4mg

• Registration Number: NCT05945797
• Lead Sponsor: Gujranwala medical college District Headquarters Hospital, Gujranwala

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-11
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-14
• Study Start: 2023-08-01
• Status Verified: 2023-11
• Primary Completion: 2023-11
• Study Completion: 2023-11
• Last Update Submitted: 2023-11-05
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexa Arm	Dexamethasone 4mg	Experimental arm patients will be receiving 2 ml (4mg) of dexamenthasone prior to undergoing ERCP.
NS Arm	Dexamethasone 4mg	Placebo arm patients will be receiving 2 ml of normal saline prior to undergoing ERCP.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gujranwala Medical College Hospital; 🇵🇰 Gujranwala, Punjab, Pakistan