Motility Disorder of IntestinePhase 4SemInERCPNCT07461389
Effects of Pre-procedure and Intra-procedure Simethicone and Dicyclomine Administration in Improving Quality of Endoscopic Reterograde Cholangipancreaticography (ERCP)
A Phase 4 study testing Preprocedural and Intraprocedural in people with Motility Disorder of Intestine and Mucosal Clarity, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motility Disorder of Intestine, Mucosal Clarity
- What is being tested?
- Preprocedural and Intraprocedural
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to 1 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients presenting for ERCP older than 18years of age.
- Patients willing to participate in the study, meeting criteria No. 1
Who cannot join
- Cases that are abandoned due to inability to access the ampulla
- Patients with grossly altered anatomy resulting in extended procedure time
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Motility Disorder of Intestine, Mucosal Clarity
- Being tested
- Preprocedural, Intraprocedural, Control
- Keywords
- ERCP, ampulla, Simethicone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreproceduralDrug
- Oral Semithicone 40mg + Dicyclomine 1mg (30min before procedure) 2. Intraprocedural water Spray
IntraproceduralDrug
- Oral Water 30mL (30min before procedure)
- Simethicone+ Dicylomine spray
ControlOther
- Oral Water 30mL (30min before procedure) +
- Intraprocedural Water Spray
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Other: Control |
| Pre Procedural Group | Experimental | 1. Oral Semithicone 40mg + Dicyclomine 1mg (30min before procedure)
2. Intraprocedural water Spray Receives: Drug: Preprocedural |
| Intraprocedural | Experimental | 1. Oral Water 30mL (30min before procedure)
2. Simethicone+ Dicylomine spray Receives: Drug: Intraprocedural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duodenal Motility
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.
Measured: 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.
- 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.
Measured: From enrollment to end of the procedure i.e.: approximately 25 minutes
Secondary outcomes (2)
Endoscopists Satisfaction
rated as good, moderate or poor.
Measured: From enrollment to end of the procedure i.e.: approximately 25 minutes
Time of the procedure
Total duration
Measured: Total procedural length approximately 25 to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Oct 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motility Disorder of IntestineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Lahore Medical College and Institute of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Malik, CMH Lahore Medical College and Institute of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461389
- Sponsor's protocol ID
- 674/2025
- Other IDs
- 674/2025
- Acronym
- SemInERCP
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Somuncu E, Sarici IS, 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 Aug;29(4):252-254. doi: 10.1097/SLE.0000000000000646.
PubMed 30768493
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-procedure and Intra-procedure Simethicone and Dicyclomine Administration in Improving Quality of Endoscopic Reterograde Cholangipancreaticography (ERCP)
- ClinicalTrials.gov ID
- NCT07461389
- Acronym / sponsor ID
- SemInERCP / 674/2025
- Conditions
- Motility Disorder of Intestine, Mucosal Clarity
- Keywords
- ERCP, ampulla, Simethicone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- CMH Lahore Medical College and Institute of DentistryUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control |
| Pre Procedural Group | Experimental | Drug: Preprocedural1. Oral Semithicone 40mg + Dicyclomine 1mg (30min before procedure) 2. Intraprocedural water Spray |
| Intraprocedural | Experimental | Drug: Intraprocedural1. Oral Water 30mL (30min before procedure) 2. Simethicone+ Dicylomine spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients presenting for ERCP older than 18years of age.
- Patients willing to participate in the study, meeting criteria No. 1
Key exclusion criteria (2 listed)
- Cases that are abandoned due to inability to access the ampulla
- Patients with grossly altered anatomy resulting in extended procedure time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preprocedural1. Oral Semithicone 40mg + Dicyclomine 1mg (30min before procedure) 2. Intraprocedural water Spray | Drug | Pre Procedural Group |
| Intraprocedural1. Oral Water 30mL (30min before procedure) 2. Simethicone+ Dicylomine spray | Drug | Intraprocedural |
| Control1. Oral Water 30mL (30min before procedure) + 2. Intraprocedural Water Spray | Other | Control |
Primary outcome
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. 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.
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. 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.
2 secondary outcomes
Endoscopists Satisfaction
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 30768493Somuncu E, Sarici IS, 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 Aug;29(4):252-254. doi: 10.1097/SLE.0000000000000646.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preprocedural and Intraprocedural in people with Motility Disorder of Intestine and Mucosal Clarity, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duodenal Motility (time frame: From enrollment to end of the procedure i.e.: approximately 25 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07461389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.