EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection

Not Applicable

Terminated

• Conditions: Early Gastric Cancer; Rectal Polyp
• Interventions: 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

• Registration Number: NCT04977401
• Lead Sponsor: Erasme University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-26
• Study Start: 2021-09-21
• Primary Completion: 2022-12-15
• Study Completion: 2023-01-05
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Glycerol	Endoscopic submucosal dissection	Submucosal injection using glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
Group Gel ORISE	Endoscopic submucosal dissection	Submucosal injection using ORISETM gel during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
Group Gel ORISE	use of Orise Gel as lifting agent for endoscopic submucosal dissection	Submucosal injection using ORISETM gel during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
Group Glycerol	use of glycerol as lifting agent for endoscopic submucosal dissection	Submucosal injection using glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.

Primary Outcome Measures

Name	Time	Method
Increase the dissection speed of the ESD procedure	At day 0 during ESD	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.

Secondary Outcome Measures

Name	Time	Method
Total procedure duration	At day 0 during ESD	Total procedure duration (from scope insertion to scope retrieval) (min)

Trial Locations

Locations (3)

Evangelisches Krankenhaus; 🇩🇪 Düsseldorf, Germany

Keio University Hospital; 🇯🇵 Tokyo, Japan

Erasme Hospital, Université Libre de Bruxelles. (ULB); 🇧🇪 Brussels, Belgium