EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection

Early Gastric Cancer Clinical Trial

— EPSILON  

Official title:

EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection: a Randomized Controlled Multicentric Trial (EPSILON)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04977401
• Other study ID #: EPSILON
• Status: Terminated
• Phase: N/A
• Start date: September 21, 2021
• Est. completion date: January 5, 2023

Study information

• Verified date: October 2023
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: January 5, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Early Gastric Cancer
• Rectal Polyp
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Erasme Hospital, Université Libre de Bruxelles. (ULB)	Brussels
Germany	Evangelisches Krankenhaus	Düsseldorf
Japan	Keio University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Countries where clinical trial is conducted

Belgium,  Germany,  Japan, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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 mu — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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 — View Citation

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 H — View Citation

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 — View Citation

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 Au — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of per-procedural bleeding	Number of per-procedural bleeding (+ severity scale: oozing / severe non pulsating/ severe pulsating)	At day 0 during ESD
Other	Total hemostatic time	Total hemostatic time (addition of each hemostasis time for each per-procedural bleeding)	At day 0 during ESD
Other	Need for haemostatic forceps	Need for haemostatic forceps during ESD	At day 0 during ESD
Other	Difficulty of the dissection	Difficulty of the dissection (scale) (very easy / easy / moderately difficult / difficult / very difficult)	At day 0 during ESD
Other	Amount of submucosal solution	Amount of submucosal solution (glycerol or gel) used for ESD in ml	At day 0 during ESD
Other	Combined use of saline	Combined use of saline through the knife during ESD (number and ml)	At day 0 during ESD
Other	Number of needle injection dots	Number of needle injection dots during ESD (initially / during ESD)	At day 0 during ESD
Other	Need to adjust electrosurgical settings	Need to adjust electrosurgical settings during ESD	At day 0 during ESD
Other	Clear visualisation of the plane of dissection during ESD (scale).	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)	At day 0 during ESD
Other	Rate of en-bloc dissection	Rate of en-bloc dissection (defined as endoscopic resection of the targeted area in one bloc)	At day 0 during ESD
Other	Rate of complete endoscopic resection	Rate of complete endoscopic resection (defined as endoscopic evaluation of complete removal of the targeted area in the treated organ)	At day 0 during ESD
Other	Quality assessment of the pathological specimen	Quality assessment of the pathological specimen (absolute measure of the depth of resected submucosa on the specimen, rate of clear (horizontal and vertical) margins)	At day 0 during ESD
Other	Adverse events	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)	From ICF signature up to 2-3 weeks follow-up
Primary	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	Total procedure duration	Total procedure duration (from scope insertion to scope retrieval) (min)	At day 0 during ESD