EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection

NCT04977401 | Terminated

• 1 other identifier: EPSILON
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 3

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.

Conditions

Early Gastric Cancer; Rectal Polyp

Keywords

ESD (endoscopic submucosal dissection); Rectum polyp; early gastric cancer; endoscopic resection; submucosal injection solution

Outcome Measures

Primary Outcomes (1)

• Increase the dissection speed of the ESD procedure

  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.

  At day 0 during ESD

Secondary Outcomes (1)

• Total procedure duration

  At day 0 during ESD

Other Outcomes (13)

• Number of per-procedural bleeding

  At day 0 during ESD

• Total hemostatic time

  At day 0 during ESD

• Need for haemostatic forceps

  At day 0 during ESD

Study Arms (2)

Group Glycerol

SHAM COMPARATOR

Submucosal injection using glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.

Procedure: Endoscopic submucosal dissection; Device: use of glycerol as lifting agent for endoscopic submucosal dissection

Group Gel ORISE

ACTIVE COMPARATOR

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; Device: use of Orise Gel as lifting agent for endoscopic submucosal dissection

Interventions

Endoscopic submucosal dissection PROCEDURE

Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope

Group Gel ORISE; Group Glycerol

use of Orise Gel as lifting agent for endoscopic submucosal dissection DEVICE

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.

Group Gel ORISE

use of glycerol as lifting agent for endoscopic submucosal dissection DEVICE

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.

Group Glycerol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (3)

Erasme Hospital, Université Libre de Bruxelles. (ULB)

Brussels, 1070, Belgium

Location

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Related Publications (13)

• Cao 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 BACKGROUND

• Fujishiro 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 RESULT

• Kodashima 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 RESULT

• Park 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 RESULT

• Lian 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 RESULT

• Pimentel-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 RESULT

• Fujishiro 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.

  PMID: 15243878 RESULT

• Castro R, Libanio D, Pita I, Dinis-Ribeiro M. Solutions for submucosal injection: What to choose and how to do it. World J Gastroenterol. 2019 Feb 21;25(7):777-788. doi: 10.3748/wjg.v25.i7.777.

  PMID: 30809079 RESULT

• Takezawa T, Hayashi Y, Shinozaki S, Sagara Y, Okada M, Kobayashi Y, Sakamoto H, Miura Y, Sunada K, Lefor AK, Yamamoto H. The pocket-creation method facilitates colonic endoscopic submucosal dissection (with video). Gastrointest Endosc. 2019 May;89(5):1045-1053. doi: 10.1016/j.gie.2019.01.022. Epub 2019 Feb 1.

  PMID: 30716306 RESULT

• Yamamoto H, Hayashi Y, Despott EJ. The pocket-creation method for endoscopic submucosal dissection combined with saline-immersion: another potential option to overcome challenges in colorectal endoscopic submucosal dissection. Gastrointest Endosc. 2019 Aug;90(2):288-289. doi: 10.1016/j.gie.2019.04.244. No abstract available.

  PMID: 31327340 RESULT

• Endoscopic Classification Review Group. Update on the paris classification of superficial neoplastic lesions in the digestive tract. Endoscopy. 2005 Jun;37(6):570-8. doi: 10.1055/s-2005-861352.

  PMID: 15933932 RESULT

• Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.

  PMID: 22609383 RESULT

• Sano Y, Tanaka S, Kudo SE, Saito S, Matsuda T, Wada Y, Fujii T, Ikematsu H, Uraoka T, Kobayashi N, Nakamura H, Hotta K, Horimatsu T, Sakamoto N, Fu KI, Tsuruta O, Kawano H, Kashida H, Takeuchi Y, Machida H, Kusaka T, Yoshida N, Hirata I, Terai T, Yamano HO, Kaneko K, Nakajima T, Sakamoto T, Yamaguchi Y, Tamai N, Nakano N, Hayashi N, Oka S, Iwatate M, Ishikawa H, Murakami Y, Yoshida S, Saito Y. Narrow-band imaging (NBI) magnifying endoscopic classification of colorectal tumors proposed by the Japan NBI Expert Team. Dig Endosc. 2016 Jul;28(5):526-33. doi: 10.1111/den.12644. Epub 2016 Apr 20.

  PMID: 26927367 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Arnaud Lemmers, MD,PhD

  Erasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, Head of Clinic, Endoscopy Unit

Model Details: 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

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 26, 2021
• Study Start: September 21, 2021
• Primary Completion: December 15, 2022
• Study Completion: January 5, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); JP (1); BE (1)