Effects of Pre-procedure and Intra-procedure Simethicone and Dicyclomine Administration in Improving Quality of Endoscopic Reterograde Cholangipancreaticography (ERCP) (SemInERCP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design: This is a randomized, double blind, controlled, trial which will be commenced after ethical approval by the institutional review board at Combined Military Hospital, Lahore. Written informed consent of all participants will be sought. Data will be prospectively collected over a period of 6 months.
Participants: Patients older than 18 years of age, presenting to the Gastroenterology department for an ERCP will be enrolled. Cases that are abandoned due to inability to access the ampulla will be excluded. Patients with grossly altered anatomy resulting in extended procedure time will also excluded.
Study Protocol: Patients will randomly assigned to one of three groups at presentation: The control group (Group 1), the pre-procedure treatment group (Group 2) and the intraprocedural treatment group (Group 3).
Patients will be randomized into three groups using block randomization. A 1:1:1 block randomization technique will be used with block sizes of 6. The random allocation sequence is generated using the randomization website https://www.sealedenvelope.com. A designated nurse shall allot the patients into the specific groups.
All procedures will be performed by two experienced endoscopists (MH and RD) using a side viewing duodenoscope. Each biliary cannulation will be attempted using a sphincterotome and 0.035" guidewire. Still images and high-quality videos will be recorded during the procedure and examined at the end of the procedure by a Hepatology fellow (MS) who is blinded to the treatment arm. The fellow shall grade the mucosal visibility and duodenal contractility using scales employed by previous studies
The four-point scale for mucosal visibility is as follows:
(0) No bubbles-the procedure could be easily performed.
- Very few bubbles-this did not interfere with the procedure.
- A slightly greater quantity of bubbles-the procedure could be performed with some difficulty.
- A large quantity of bubbles interfering with the procedure-accurate evaluation was impossible.
The duodenal motility was graded as follows:
(0) No contractions were observed.
- <5 contractions per minute were observed.
- 5 to 10 contractions per minute were observed.
- 11 to 15 contractions per minute were observed.
- Continuous contractions were observed. At the end of the procedure, the endoscopist satisfaction will be inquired and rated as good, moderate or poor. The total procedural time will also be recorded.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- CMH Lahore Medical College
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients presenting for ERCP older than 18years of age.
- Patients willing to participate in the study, meeting criteria No. 1
Exclusion Criteria:
- Cases that are abandoned due to inability to access the ampulla
- Patients with grossly altered anatomy resulting in extended procedure time
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
|
|
|
Experimental: Pre Procedural Group
|
1. Oral Semithicone 40mg + Dicyclomine 1mg (30min before procedure) 2. Intraprocedural water Spray
|
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Experimental: Intraprocedural
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duodenal Motility
Time Frame: From enrollment to end of the procedure i.e.: approximately 25 minutes
|
The duodenal motility was graded as follows (0) No contractions were observed.
|
From enrollment to end of the procedure i.e.: approximately 25 minutes
|
|
Mucosal Visibility
Time Frame: From enrollment to end of the procedure i.e.: approximately 25 minutes
|
assessed using a 4 point scale as follows (0) No bubbles-the procedure could be easily performed.
|
From enrollment to end of the procedure i.e.: approximately 25 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endoscopists Satisfaction
Time Frame: From enrollment to end of the procedure i.e.: approximately 25 minutes
|
rated as good, moderate or poor.
|
From enrollment to end of the procedure i.e.: approximately 25 minutes
|
|
Time of the procedure
Time Frame: Total procedural length approximately 25 to 45 minutes
|
Total duration
|
Total procedural length approximately 25 to 45 minutes
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 674/2025 (Other Identifier: CMH Lahore Pakistan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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