Effects of Dexamethasone on Common Bile Duct Cannulation Time

Study Overview
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Brief Summary
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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.

Official Title
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Can Deep Common Bile Duct Cannulation Time During Endoscopic Retrograde Cholangiopancreatography be Shortened by Dexamethasone

Conditions
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Common Bile Duct Diseases, Common Bile Duct Calculi, Common Bile Duct Stricture, Common Bile Duct Neoplasms, Common Bile Duct Dilatation

Intervention / Treatment
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* Drug: Dexamethasone 4mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shortening of CBD cannulation time | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, Steroids, Dexamethasone, CBD cannulation time