Clinical trial NCT04977401: EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection
Official title: EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection: a Randomized Controlled Multicentric Trial (EPSILON)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Early Gastric Cancer
Rectal Polyp
Keywords: ESD (endoscopic submucosal dissection)
Rectum polyp
early gastric cancer
endoscopic resection
submucosal injection solution
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Increase the dissection speed of the ESD procedure
timeFrame: At day 0 during ESD
Secondary outcomes:
measure: Total procedure duration
timeFrame: At day 0 during ESD
Other outcomes:
measure: Number of per-procedural bleeding
timeFrame: At day 0 during ESD
measure: Total hemostatic time
timeFrame: At day 0 during ESD
measure: Need for haemostatic forceps
timeFrame: At day 0 during ESD
measure: Difficulty of the dissection
timeFrame: At day 0 during ESD
measure: Amount of submucosal solution
timeFrame: At day 0 during ESD
measure: Combined use of saline
timeFrame: At day 0 during ESD
measure: Number of needle injection dots
timeFrame: At day 0 during ESD
measure: Need to adjust electrosurgical settings
timeFrame: At day 0 during ESD
measure: Clear visualisation of the plane of dissection during ESD (scale).
timeFrame: At day 0 during ESD
measure: Rate of en-bloc dissection
timeFrame: At day 0 during ESD
measure: Rate of complete endoscopic resection
timeFrame: At day 0 during ESD
measure: Quality assessment of the pathological specimen
timeFrame: At day 0 during ESD
measure: Adverse events
timeFrame: From ICF signature up to 2-3 weeks follow-up
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital, Université Libre de Bruxelles. (ULB)
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Tokyo
country: Japan
facility: Keio University Hospital
Study officials:
affiliation: Erasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, Belgium
name: Arnaud Lemmers, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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