EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection

Study Overview
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Brief Summary
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The EPSILON study aims to comparatively evaluate the submucosal injection using ORISETM gel and glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.

Detailed Description
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Traditionally, ESD requires the injection of some colloidal solution (glycerol, geloplasma, hydroxyethylstrach, etc.) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion. Alternatives to colloid-solution assisted ESD have also been developped: pocket creation method and saline-immersion ESD. Recently, other colloidal solutions have arrived on the market, such as gel (ORISETM gel) in order to improve the lifting during ESD.Our preliminary experience using ORISETM gel as a lifting solution for ESD was unexpectedly favourable with few per-procedural bleeding, quick time and facility. As the spread of ESD is closely associated to its easiness, procedure duration (itself associated to number of procedural bleedings and instruments change through the operating channel) and safety, we sought to study comparatively two submucosal solutions when conducting ESD in a specific population presenting gastric or rectal superficial lesions.

Official Title
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EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection: a Randomized Controlled Multicentric Trial (EPSILON)

Conditions
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Early Gastric Cancer, Rectal Polyp

Intervention / Treatment
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* Procedure: Endoscopic submucosal dissection
* Device: use of Orise Gel as lifting agent for endoscopic submucosal dissection
* Device: use of glycerol as lifting agent for endoscopic submucosal dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: o Patients must have given written informed consent o Subjects with documented gastric or rectal lesions with indication of endoscopic removal by ESD, namely: Gastric focal lesion with suspicion of early gastric cancer (low or high grade dysplasia with features of early gastric cancer; adenocarcinoma with morphology of superficial lesion and work-up of superficial lesion) Rectal polyps (adenoma or superficial carcinoma) from 0 to 15 cm from the anal margin; with features being recognized indications of ESD: more than 20mm granular LST, more than 20mm non granular LST, more than 20mm villous or bulging polyps, Paris 0-IIa+IIc lesions, lesions with suspicious pattern (Kudo Vi / JNET 2B), lesions with anal canal involvement. Exclusion Criteria: Subjects who meet any of the following exclusion criteria cannot be enrolled in the study: Gastric and rectal neuroendocrine tumour (NET) with indication of ESD will be excluded Gastric and rectal lesions with indication of ESD but strong fibrosis due to previous partial resection will be excluded Subject is currently enrolled in another confounding research Subjects with any other location of ESD (esophagus, duodenum and colon) will not be included.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A multicentric, randomized, open label prospective study: All subjects with indications of gastric and rectal ESD undergo screening and baseline visit Informed consent is obtained when scheduling the ESD procedure Randomization is made at the time of the ESD procedure after confirmation of the indication ESD is performed using a 25 G needle, a dual-knife-J with glycerol (standard solution) or ORISETM gel in order to remove the lesion en-bloc. Additional saline injection through the electrosurgical knife will be left at the discretion of the endoscopist A follow-up visit is scheduled at 2-4 weeks
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group Glycerol<br>Submucosal injection using glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions. | Procedure: Endoscopic submucosal dissection<br>* Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope<br>Device: use of glycerol as lifting agent for endoscopic submucosal dissection<br>* Injection of some colloidal solution (glycerol) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion.<br>|
| Active Comparator: Group Gel ORISE<br>Submucosal injection using ORISETM gel during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions. | Procedure: Endoscopic submucosal dissection<br>* Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope<br>Device: use of Orise Gel as lifting agent for endoscopic submucosal dissection<br>* Injection of some colloidal solution (ORISE gel) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase the dissection speed of the ESD procedure | Increase the dissection speed of the ESD procedure (defined as the dissected surface (mm2)/ESD duration (min). The dissected surface is defined as maximal diameter of specimen (mm) x perpendicular minimal diameter of specimen (mm) measured on ex-vivo pinned stretched specimen onto a cork. ESD duration is defined as the time from first submucosal injection to final cut time. | At day 0 during ESD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total procedure duration | Total procedure duration (from scope insertion to scope retrieval) (min) | At day 0 during ESD | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESD (endoscopic submucosal dissection), Rectum polyp, early gastric cancer, endoscopic resection, submucosal injection solution