Early Gastric Cancer, Rectal Polyp
Conditions
Keywords
ESD (endoscopic submucosal dissection), Rectum polyp, early gastric cancer, endoscopic resection, submucosal injection solution
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.
Interventions
PROCEDUREEndoscopic submucosal dissection
Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope
DEVICEuse 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.
DEVICEuse 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.
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Total procedure duration | At day 0 during ESD | Total procedure duration (from scope insertion to scope retrieval) (min) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Total hemostatic time | At day 0 during ESD | Total hemostatic time (addition of each hemostasis time for each per-procedural bleeding) |
| 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) |
| Need to adjust electrosurgical settings | At day 0 during ESD | Need to adjust electrosurgical settings during ESD |
| Number of per-procedural bleeding | At day 0 during ESD | Number of per-procedural bleeding (+ severity scale: oozing / severe non pulsating/ severe pulsating) |
Countries
Belgium, Germany, Japan
Outcome results
None listed