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| ID | Type | Description | Link |
|---|---|---|---|
| 674/2025 | Other Identifier | CMH Lahore Pakistan |
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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 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.
The duodenal motility was graded as follows:
(0) No contractions were observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator |
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| Pre Procedural Group | Experimental |
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| Intraprocedural | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preprocedural | Drug | 1. Oral Semithicone 40mg + Dicyclomine 1mg (30min before procedure) 2. Intraprocedural water Spray |
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| Measure | Description | Time Frame |
|---|---|---|
| Duodenal Motility | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopists Satisfaction | rated as good, moderate or poor. | From enrollment to end of the procedure i.e.: approximately 25 minutes |
| Time of the procedure | Total duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMH Lahore Medical College | Lahore | Punjab Province | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30768493 | Background | 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. |
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| Intraprocedural | Drug |
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| Control | Other |
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| Total procedural length approximately 25 to 45 minutes |