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

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ClinicalTrials.gov Identifier: NCT04977401
Recruitment Status : Not yet recruiting
First Posted : July 26, 2021
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Lemmers Arnaud, Erasme University Hospital

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
Early Gastric Cancer Rectal Polyp Procedure: Endoscopic submucosal dissection Device: use of Orise Gel as lifting agent for endoscopic submucosal dissection Device: use of glycerol as lifting agent for endoscopic submucosal dissection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (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.
Primary Purpose: Treatment
Official Title: EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection: a Randomized Controlled Multicentric Trial (EPSILON)
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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.




Primary Outcome Measures :
  1. Increase the dissection speed of the ESD procedure [ Time Frame: 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 :
  1. Total procedure duration [ Time Frame: At day 0 during ESD ]
    Total procedure duration (from scope insertion to scope retrieval) (min)


Other Outcome Measures:
  1. Number of per-procedural bleeding [ Time Frame: At day 0 during ESD ]
    Number of per-procedural bleeding (+ severity scale: oozing / severe non pulsating/ severe pulsating)

  2. Total hemostatic time [ Time Frame: At day 0 during ESD ]
    Total hemostatic time (addition of each hemostasis time for each per-procedural bleeding)

  3. Need for haemostatic forceps [ Time Frame: At day 0 during ESD ]
    Need for haemostatic forceps during ESD

  4. Difficulty of the dissection [ Time Frame: At day 0 during ESD ]
    Difficulty of the dissection (scale) (very easy / easy / moderately difficult / difficult / very difficult)

  5. Amount of submucosal solution [ Time Frame: At day 0 during ESD ]
    Amount of submucosal solution (glycerol or gel) used for ESD in ml

  6. Combined use of saline [ Time Frame: At day 0 during ESD ]
    Combined use of saline through the knife during ESD (number and ml)

  7. Number of needle injection dots [ Time Frame: At day 0 during ESD ]
    Number of needle injection dots during ESD (initially / during ESD)

  8. Need to adjust electrosurgical settings [ Time Frame: At day 0 during ESD ]
    Need to adjust electrosurgical settings during ESD

  9. Clear visualisation of the plane of dissection during ESD (scale). [ Time Frame: 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)


  10. Rate of en-bloc dissection [ Time Frame: At day 0 during ESD ]
    Rate of en-bloc dissection (defined as endoscopic resection of the targeted area in one bloc)

  11. Rate of complete endoscopic resection [ Time Frame: 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)

  12. Quality assessment of the pathological specimen [ Time Frame: 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)

  13. Adverse events [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04977401


Contacts
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Contact: Arnaud Lemmers, MD,PhD +325556559 arnaud.lemmers@erasme.ulb.ac.be
Contact: Dimitri Oger +3225555828 dimitrioger@erasme.ulb.ac.be

Locations
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United States, New York
Sloan Memorial Kettering Cancer Center
New York, New York, United States, 10065
Contact: Makoto Nishimura, MD       nishimum@mskcc.org   
Contact: Laura Kakalios       kakaliol@mskcc.org   
Principal Investigator: Makoto Nishimura, MD         
Sub-Investigator: Galen Leung, MD         
Belgium
Erasme Hospital, Université Libre de Bruxelles. (ULB)
Brussels, Belgium, 1070
Contact: Arnaud Lemmers, MD, PhD    +3225556559    arnaud.lemmers@erasme.ulb.ac.be   
Contact: Dimitri Oger    +3225555828    dimitri.oger@erasme.ulb.ac.be   
Sub-Investigator: Vincent Huberty, MD, PhD         
Sub-Investigator: Ana-Maria Bucalau, MD         
Germany
Evangelisches Krankenhaus
Düsseldorf, Germany, 40217
Contact: Torsten Beyna, MD, PhD       Torsten.Beyna@evk-duesseldorf.de   
Contact       Studien@evk-duesseldorf.de   
Principal Investigator: Torsten Beyna, MD, PhD         
Sub-Investigator: Horst Neuhaus, MD, PhD         
Japan
Keio University Hospital
Tokyo, Japan, 160-8582
Contact: Naohisa Yahagi, MD, PhD       yahagi-tky@umin.ac.jp   
Principal Investigator: Naohisa Yahagi, MD, PhD         
Sub-Investigator: Matsura Noriko, MD         
Sub-Investigator: Motohiko Kato, MD, PhD         
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Principal Investigator: Arnaud Lemmers, MD,PhD Erasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, Belgium
  Study Documents (Full-Text)

Documents provided by Lemmers Arnaud, Erasme University Hospital:
Study Protocol  [PDF] July 21, 2021
Statistical Analysis Plan  [PDF] July 21, 2021

Publications of Results:

Other Publications:
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Responsible Party: Lemmers Arnaud, MD, PhD, Professor, Head of Clinic, Endoscopy Unit, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT04977401    
Other Study ID Numbers: P2021-208
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lemmers Arnaud, Erasme University Hospital:
ESD (endoscopic submucosal dissection)
Rectum polyp
early gastric cancer
endoscopic resection
submucosal injection solution
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs