EPSILON: EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Total procedure duration [At day 0 during ESD]
Total procedure duration (from scope insertion to scope retrieval) (min)
Other Outcome Measures
- Number of per-procedural bleeding [At day 0 during ESD]
Number of per-procedural bleeding (+ severity scale: oozing / severe non pulsating/ severe pulsating)
- Total hemostatic time [At day 0 during ESD]
Total hemostatic time (addition of each hemostasis time for each per-procedural bleeding)
- Need for haemostatic forceps [At day 0 during ESD]
Need for haemostatic forceps during ESD
- Difficulty of the dissection [At day 0 during ESD]
Difficulty of the dissection (scale) (very easy / easy / moderately difficult / difficult / very difficult)
- Amount of submucosal solution [At day 0 during ESD]
Amount of submucosal solution (glycerol or gel) used for ESD in ml
- Combined use of saline [At day 0 during ESD]
Combined use of saline through the knife during ESD (number and ml)
- Number of needle injection dots [At day 0 during ESD]
Number of needle injection dots during ESD (initially / during ESD)
- Need to adjust electrosurgical settings [At day 0 during ESD]
Need to adjust electrosurgical settings during ESD
- Clear visualisation of the plane of dissection during ESD (scale). [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)
- Rate of en-bloc dissection [At day 0 during ESD]
Rate of en-bloc dissection (defined as endoscopic resection of the targeted area in one bloc)
- Rate of complete endoscopic resection [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)
- Quality assessment of the pathological specimen [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)
- Adverse events [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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o Patients must have given written informed consent
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o Subjects with documented gastric or rectal lesions with indication of endoscopic removal by ESD, namely:
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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)
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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:
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Subjects who meet any of the following exclusion criteria cannot be enrolled in the study:
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Gastric and rectal neuroendocrine tumour (NET) with indication of ESD will be excluded
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Gastric and rectal lesions with indication of ESD but strong fibrosis due to previous partial resection will be excluded
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Subject is currently enrolled in another confounding research
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Subjects with any other location of ESD (esophagus, duodenum and colon) will not be included.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sloan Memorial Kettering Cancer Center | New York | New York | United States | 10065 |
| 2 | Erasme Hospital, Université Libre de Bruxelles. (ULB) | Brussels | Belgium | 1070 | |
| 3 | Evangelisches Krankenhaus | Düsseldorf | Germany | 40217 | |
| 4 | Keio University Hospital | Tokyo | Japan | 160-8582 |
Sponsors and Collaborators
- Erasme University Hospital
Investigators
- Principal Investigator: Arnaud Lemmers, MD,PhD, Erasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, Belgium
Study Documents (Full-Text)
More Information
Publications
- P2021-208