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Glycerol

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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.

Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope

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.

use of Orise Gel 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.

use of glycerol as lifting agent for endoscopic submucosal dissection

Arnaud Lemmers, MD,PhD

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.

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.

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

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.

EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection

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

Number of per-procedural bleeding (+ severity scale: oozing / severe non pulsating/ severe pulsating)

Total hemostatic time (addition of each hemostasis time for each per-procedural bleeding)

Difficulty of the dissection (scale) (very easy / easy / moderately difficult / difficult / very difficult)

Amount of submucosal solution (glycerol or gel) used for ESD in ml

Combined use of saline through the knife during ESD (number and ml)

Number of needle injection dots during ESD (initially / during ESD)

Need to adjust electrosurgical settings 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)

Rate of en-bloc dissection (defined as endoscopic resection of the targeted area in one bloc)

Rate of complete endoscopic resection (defined as endoscopic evaluation of complete removal of the targeted area in the treated organ)

Quality assessment of the pathological specimen (absolute measure of the depth of resected submucosa on the specimen, rate of clear (horizontal and vertical) margins)

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)

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection	NCT04977401	Early Gastric C... Rectal Polyp	Endoscopic subm... use of Orise Ge... use of glycerol...	18 Years -	Erasme University Hospital
EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection	NCT04977401	Early Gastric C... Rectal Polyp	Endoscopic subm... use of Orise Ge... use of glycerol...	18 Years -	Erasme University Hospital

Spots Global Cancer Trial Database for use of orise gel as lifting agent for endoscopic submucosal dissection