Clinical trial · Interventional
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)
NCT04977401CI-TRIAL-00070673EPSILONterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Urgent Medical Device Product (ORISE Gel Submucosal Liftiong Agent) Removal by sponsor
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Rectal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic submucosal dissection | Procedure | — | UNRESOLVED |
| use of glycerol as lifting agent for endoscopic submucosal dissection | Device | — | UNRESOLVED |
| use of Orise Gel as lifting agent for endoscopic submucosal dissection | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Group Glycerol
- description
- Submucosal injection using glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
- interventionNames
- Procedure: Endoscopic submucosal dissection
- Device: use of glycerol as lifting agent for endoscopic submucosal dissection
- type
- ACTIVE_COMPARATOR
- label
- Group Gel ORISE
- description
- Submucosal injection using ORISETM gel during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.
- interventionNames
- Procedure: Endoscopic submucosal dissection
- Device: use of Orise Gel as lifting agent for endoscopic submucosal dissection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (13)
- BACKGROUNDCao Y, Liao C, Tan A, Gao Y, Mo Z, Gao F. Meta-analysis of endoscopic submucosal dissection versus endoscopic mucosal resection for tumors of the gastrointestinal tract. Endoscopy. 2009 Sep;41(9):751-7. doi: 10.1055/s-0029-1215053. Epub 2009 Aug 19. PMID 19693750
- RESULTFujishiro M. Perspective on the practical indications of endoscopic submucosal dissection of gastrointestinal neoplasms. World J Gastroenterol. 2008 Jul 21;14(27):4289-95. doi: 10.3748/wjg.14.4289. PMID 18666315
- RESULTKodashima S, Fujishiro M, Yahagi N, Kakushima N, Omata M. Endoscopic submucosal dissection using flexknife. J Clin Gastroenterol. 2006 May-Jun;40(5):378-84. doi: 10.1097/00004836-200605000-00004. PMID 16721217
- RESULTPark YM, Cho E, Kang HY, Kim JM. The effectiveness and safety of endoscopic submucosal dissection compared with endoscopic mucosal resection for early gastric cancer: a systematic review and metaanalysis. Surg Endosc. 2011 Aug;25(8):2666-77. doi: 10.1007/s00464-011-1627-z. Epub 2011 Mar 18. PMID 21424201
- RESULTLian J, Chen S, Zhang Y, Qiu F. A meta-analysis of endoscopic submucosal dissection and EMR for early gastric cancer. Gastrointest Endosc. 2012 Oct;76(4):763-70. doi: 10.1016/j.gie.2012.06.014. Epub 2012 Aug 9. PMID 22884100
- RESULTPimentel-Nunes P, Dinis-Ribeiro M, Ponchon T, Repici A, Vieth M, De Ceglie A, Amato A, Berr F, Bhandari P, Bialek A, Conio M, Haringsma J, Langner C, Meisner S, Messmann H, Morino M, Neuhaus H, Piessevaux H, Rugge M, Saunders BP, Robaszkiewicz M, Seewald S, Kashin S, Dumonceau JM, Hassan C, Deprez PH. Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2015 Sep;47(9):829-54. doi: 10.1055/s-0034-1392882. Epub 2015 Aug 28. PMID 26317585
- RESULTFujishiro M, Yahagi N, Kashimura K, Mizushima Y, Oka M, Enomoto S, Kakushima N, Kobayashi K, Hashimoto T, Iguchi M, Shimizu Y, Ichinose M, Omata M. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004 Jul;36(7):579-83. doi: 10.1055/s-2004-814517.