EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection (EPSILON)

Free University of Brussels (ULB)

Status: Terminated

Conditions: Early Gastric Cancer; Rectal Polyp

Treatments: Device: use of Orise Gel as lifting agent for endoscopic submucosal dissection; Procedure: Endoscopic submucosal dissection; Device: use of glycerol as lifting agent for endoscopic submucosal dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT04977401

EPSILON

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Group Glycerol

Sham Comparator group

Description:

Submucosal injection using glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.

Treatment:

Device: use of glycerol as lifting agent for endoscopic submucosal dissection

Procedure: Endoscopic submucosal dissection

Group Gel ORISE

Active Comparator group

Description:

Submucosal injection using ORISETM gel during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.

Treatment:

Procedure: Endoscopic submucosal dissection

Device: use of Orise Gel as lifting agent for endoscopic submucosal dissection