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

October 20, 2023 updated by: Lemmers Arnaud, Erasme University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Erasme Hospital, Université Libre de Bruxelles. (ULB)
  • Germany
      • Düsseldorf, Germany, 40217
        • Evangelisches Krankenhaus
  • Japan
      • Tokyo, Japan, 160-8582
        • Keio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Group Glycerol
Submucosal injection using glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
Procedure: Endoscopic submucosal dissection
Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope
Device: use of glycerol as lifting agent for endoscopic submucosal dissection
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.
Active Comparator: Group Gel ORISE
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
Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope
Device: use of Orise Gel as lifting agent for endoscopic submucosal dissection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase the dissection speed of the ESD procedure
Time Frame: 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.
At day 0 during ESD

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of per-procedural bleeding
Time Frame: At day 0 during ESD
Number of per-procedural bleeding (+ severity scale: oozing / severe non pulsating/ severe pulsating)
At day 0 during ESD
Total hemostatic time
Time Frame: At day 0 during ESD
Total hemostatic time (addition of each hemostasis time for each per-procedural bleeding)
At day 0 during ESD
Need for haemostatic forceps
Time Frame: At day 0 during ESD
Need for haemostatic forceps during ESD
At day 0 during ESD
Difficulty of the dissection
Time Frame: At day 0 during ESD
Difficulty of the dissection (scale) (very easy / easy / moderately difficult / difficult / very difficult)
At day 0 during ESD
Amount of submucosal solution
Time Frame: At day 0 during ESD
Amount of submucosal solution (glycerol or gel) used for ESD in ml
At day 0 during ESD
Combined use of saline
Time Frame: At day 0 during ESD
Combined use of saline through the knife during ESD (number and ml)
At day 0 during ESD
Number of needle injection dots
Time Frame: At day 0 during ESD
Number of needle injection dots during ESD (initially / during ESD)
At day 0 during ESD
Need to adjust electrosurgical settings
Time Frame: At day 0 during ESD
Need to adjust electrosurgical settings during ESD
At day 0 during ESD
Clear visualisation of the plane of dissection during ESD (scale).
Time Frame: At day 0 during ESD

Clear visualisation of the plane of dissection during ESD (scale). The scale will be defined according the endoscopists evaluation of the delineation between the submucosa ad the underlying muscular layer:

  • Very-good visualization: clear delineation between the two layers with clear visualization of the blood vessels.
  • Good visualization: mostly clear delineation between the two layers, but with blurred regions
  • Bad visualization: delineation between the two layers is unclear (i.e.:

fibrosis)
At day 0 during ESD
Rate of en-bloc dissection
Time Frame: At day 0 during ESD
Rate of en-bloc dissection (defined as endoscopic resection of the targeted area in one bloc)
At day 0 during ESD
Rate of complete endoscopic resection
Time Frame: At day 0 during ESD
Rate of complete endoscopic resection (defined as endoscopic evaluation of complete removal of the targeted area in the treated organ)
At day 0 during ESD
Quality assessment of the pathological specimen
Time Frame: At day 0 during ESD
Quality assessment of the pathological specimen (absolute measure of the depth of resected submucosa on the specimen, rate of clear (horizontal and vertical) margins)
At day 0 during ESD
Adverse events
Time Frame: From ICF signature up to 2-3 weeks follow-up

Adverse events:

  • Per-procedural (incidence of all adverse technical events during the procedure)
  • Early (clinical and laboratory at 24 h post procedure according to CTCAE v 5.0)
  • Late (clinical at 2-3 weeks follow-up)
From ICF signature up to 2-3 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Investigators

  • Principal Investigator: Arnaud Lemmers, MD,PhD, Erasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

January 5, 2023

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

July 26, 2021

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPSILON

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Gastric Cancer

Clinical Trials on Endoscopic submucosal dissection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe