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ACTIVE NOT RECRUITING
NCT07461389
PHASE4

Effects of Pre-procedure and Intra-procedure Simethicone and Dicyclomine Administration in Improving Quality of Endoscopic Reterograde Cholangipancreaticography (ERCP)

Sponsor: CMH Lahore Medical College and Institute of Dentistry

View on ClinicalTrials.gov

Summary

Endoscopic Reterograde Cholangiopancreatography is widely used to diagnose and treat hepatobiliary disorders. Ampullary cannulation is an essential step and good mucosal visibility improves procedural efficiency. Objective of the study: Our study aims to investigate the effects of Pre-procedural and intra-procedural administration of Semithicone as a defoaming agent and Dicylomine in reducing duodenal contractions. Methodology: A randomized, double blind, controlled, trial will be conducted at Combined Military Hospital, Lahore after obtaining informed consent. Data will be prospectively collected over a period of 6 months. Patients will be randomized into three groups using block randomization and split into 3 groups i.e: Group 1: control (no intervention), Group 2: Pre procedural semithicone administration and Group 3: intraprocedural administration. Mucosal visibility and duodenal motility will be assessed using a scale. Procedure time and endoscopists' satisfaction will be inquired.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-10-01

Completion Date

2026-04-01

Last Updated

2026-03-10

Healthy Volunteers

Yes

Interventions

DRUG

Preprocedural

1\. Oral Semithicone 40mg + Dicyclomine 1mg (30min before procedure) 2. Intraprocedural water Spray

DRUG

Intraprocedural

1. Oral Water 30mL (30min before procedure) 2. Simethicone+ Dicylomine spray

OTHER

Control

1. Oral Water 30mL (30min before procedure) + 2. Intraprocedural Water Spray

Locations (1)

CMH Lahore Medical College

Lahore, Punjab Province, Pakistan