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

NCT07461389 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Motility Disorder of Intestine
  • Mucosal Clarity

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

Sponsors & Collaborators

  • CMH Lahore Medical College and Institute of Dentistry

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-04-01
Completion
2026-04-01
FDA Drug
Yes

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07461389 on ClinicalTrials.gov