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

NCT07461389 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 674/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Mucosal Clarity; Motility Disorder of Intestine

Keywords

ERCP; ampulla; Simethicone

Outcome Measures

Primary Outcomes (2)

• Duodenal Motility

  The duodenal motility was graded as follows (0) No contractions were observed. 1. \<5 contractions per minute were observed. 2. 5 to 10 contractions per minute were observed. 3. 11 to 15 contractions per minute were observed. 4. Continuous contractions were observed.

  From enrollment to end of the procedure i.e.: approximately 25 minutes

• Mucosal Visibility

  assessed using a 4 point scale as follows (0) No bubbles-the procedure could be easily performed. 1. Very few bubbles-this did not interfere with the procedure. 2. A slightly greater quantity of bubbles-the procedure could be performed with some difficulty. 3. A large quantity of bubbles interfering with the procedure-accurate evaluation was impossible.

  From enrollment to end of the procedure i.e.: approximately 25 minutes

Secondary Outcomes (2)

• Endoscopists Satisfaction

  From enrollment to end of the procedure i.e.: approximately 25 minutes

• Time of the procedure

  Total procedural length approximately 25 to 45 minutes

Study Arms (3)

Control

PLACEBO COMPARATOR

Other: Control

Pre Procedural Group

EXPERIMENTAL

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

Drug: Preprocedural

Intraprocedural

EXPERIMENTAL

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

Drug: Intraprocedural

Interventions

Intraprocedural DRUG

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

Intraprocedural

Control OTHER

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

Control

Preprocedural DRUG

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

Pre Procedural Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting for ERCP older than 18years of age.
• Patients willing to participate in the study, meeting criteria No. 1

You may not qualify if:

• Cases that are abandoned due to inability to access the ampulla
• Patients with grossly altered anatomy resulting in extended procedure time

Sponsors & Collaborators

• CMH Lahore Medical College and Institute of Dentistry: lead

Study Sites (1)

CMH Lahore Medical College

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

• Somuncu E, Sarici İS, Caliskan YK, Kalayci MU. Preprocedural administration of simethicone and otilonium bromide improves the quality of endoscopic retrograde cholangiopancreatography: A prospective randomized trial. Surg Laparosc Endosc Percutan Tech. 2019;29(4):252-4. Available from: http://dx.doi.org/10.1097/SLE.0000000000000646

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 10, 2026
• Study Start: October 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-02

Locations

PA (1)