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

Primary Purpose

Early Gastric Cancer, Rectal Polyp

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endoscopic submucosal dissection
use of Orise Gel as lifting agent for endoscopic submucosal dissection
use of glycerol as lifting agent for endoscopic submucosal dissection
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Gastric Cancer focused on measuring ESD (endoscopic submucosal dissection), Rectum polyp, early gastric cancer, endoscopic resection, submucosal injection solution

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Erasme Hospital, Université Libre de Bruxelles. (ULB)
  • Evangelisches Krankenhaus
  • Keio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Group Glycerol

Group Gel ORISE

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total procedure duration
Total procedure duration (from scope insertion to scope retrieval) (min)

Full Information

First Posted
July 8, 2021
Last Updated
October 20, 2023
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04977401
Brief Title
EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection
Acronym
EPSILON
Official Title
EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection: a Randomized Controlled Multicentric Trial (EPSILON)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Urgent Medical Device Product (ORISE Gel Submucosal Liftiong Agent) Removal by sponsor
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
January 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasme University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer, Rectal Polyp
Keywords
ESD (endoscopic submucosal dissection), Rectum polyp, early gastric cancer, endoscopic resection, submucosal injection solution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
A computer-based block randomization scheme will be created using block randomization and stratifying by center and by organ type (stomach/rectum). Data will be collected through a printed CRFs and then anonymized and entered into a central web based secured platform.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Glycerol
Arm Type
Sham Comparator
Arm Description
Submucosal injection using glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
Arm Title
Group Gel ORISE
Arm Type
Active Comparator
Arm Description
Submucosal injection using ORISETM gel during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic submucosal dissection
Intervention Description
Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope
Intervention Type
Device
Intervention Name(s)
use of Orise Gel as lifting agent for endoscopic submucosal dissection
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
use of glycerol as lifting agent for endoscopic submucosal dissection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase the dissection speed of the ESD procedure
Description
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.
Time Frame
At day 0 during ESD
Secondary Outcome Measure Information:
Title
Total procedure duration
Description
Total procedure duration (from scope insertion to scope retrieval) (min)
Time Frame
At day 0 during ESD
Other Pre-specified Outcome Measures:
Title
Number of per-procedural bleeding
Description
Number of per-procedural bleeding (+ severity scale: oozing / severe non pulsating/ severe pulsating)
Time Frame
At day 0 during ESD
Title
Total hemostatic time
Description
Total hemostatic time (addition of each hemostasis time for each per-procedural bleeding)
Time Frame
At day 0 during ESD
Title
Need for haemostatic forceps
Description
Need for haemostatic forceps during ESD
Time Frame
At day 0 during ESD
Title
Difficulty of the dissection
Description
Difficulty of the dissection (scale) (very easy / easy / moderately difficult / difficult / very difficult)
Time Frame
At day 0 during ESD
Title
Amount of submucosal solution
Description
Amount of submucosal solution (glycerol or gel) used for ESD in ml
Time Frame
At day 0 during ESD
Title
Combined use of saline
Description
Combined use of saline through the knife during ESD (number and ml)
Time Frame
At day 0 during ESD
Title
Number of needle injection dots
Description
Number of needle injection dots during ESD (initially / during ESD)
Time Frame
At day 0 during ESD
Title
Need to adjust electrosurgical settings
Description
Need to adjust electrosurgical settings during ESD
Time Frame
At day 0 during ESD
Title
Clear visualisation of the plane of dissection during ESD (scale).
Description
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)
Time Frame
At day 0 during ESD
Title
Rate of en-bloc dissection
Description
Rate of en-bloc dissection (defined as endoscopic resection of the targeted area in one bloc)
Time Frame
At day 0 during ESD
Title
Rate of complete endoscopic resection
Description
Rate of complete endoscopic resection (defined as endoscopic evaluation of complete removal of the targeted area in the treated organ)
Time Frame
At day 0 during ESD
Title
Quality assessment of the pathological specimen
Description
Quality assessment of the pathological specimen (absolute measure of the depth of resected submucosa on the specimen, rate of clear (horizontal and vertical) margins)
Time Frame
At day 0 during ESD
Title
Adverse events
Description
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)
Time Frame
From ICF signature up to 2-3 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Lemmers, MD,PhD
Organizational Affiliation
Erasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme Hospital, Université Libre de Bruxelles. (ULB)
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Evangelisches Krankenhaus
City
Düsseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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19693750
Citation
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Results Reference
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Fujishiro M. Perspective on the practical indications of endoscopic submucosal dissection of gastrointestinal neoplasms. World J Gastroenterol. 2008 Jul 21;14(27):4289-95. doi: 10.3748/wjg.14.4289.
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Citation
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EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection

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