This Randomized, Single-center Trial Aims to Evaluate the Advantages of Underwater ESD (U-ESD) in Comparison to the Conventional ESD (C-ESD).
NCT ID: NCT07040020
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
122 participants
INTERVENTIONAL
2025-03-31
2026-03-31
Brief Summary
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Nevertheless, colorectal ESD is burdened by technical difficulties and several adverse events affecting its outcomes. The adverse events could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs. Failure of endoscopic resection requiring surgery for benign lesions could affect patients' quality of life and increase healthcare systems' costs.
Thus, improving colorectal ESD outcomes is an important clinical and medico-economic objective. The underwater setting with saline has been already established as a better option than conventional CO2 insufflation for EMR of large colonic polyps. Moreover, use of the underwater approach for colorectal ESD has been increasingly reported with good results in the last few years. However, a randomized comparative trial between conventional and underwater colorectal ESD clarifying which should be the preferred approach is lacking.
Expected benefits are a decrease of adverse events and an increase of successful R0 resection rate of colorectal ESD.
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Detailed Description
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Underwater ESD is a technique wherein the polyp is removed in an en bloc fashion. The procedure initiates with the identification and delineation of the polyp borders through careful endoscopic examination. Subsequently, after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed to lift the lesion. After that, subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection will be performed.
The clinical practice and technique of underwater ESD and conventional ESD performed during the course of the trial, will not be modified from standard clinical practice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional ESD
Conventional ESD (C-ESD): under CO2 insufflation, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out
Conventional ESD (C-ESD)
Conventional ESD (C-ESD): under CO2 insufflation, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out.
Underwater ESD (U-ESD)
Underwater ESD (U-ESD): after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out.
Underwater ESD (U-ESD)
Underwater ESD (U-ESD): after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out
Interventions
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Underwater ESD (U-ESD)
Underwater ESD (U-ESD): after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out
Conventional ESD (C-ESD)
Conventional ESD (C-ESD): under CO2 insufflation, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out.
Eligibility Criteria
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Inclusion Criteria
* patients who were able to give informed written consent
Exclusion Criteria
* Suspicion of serrated/hyperplastic polyps by analysis of pit pattern (Kudo IIo)
* Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)
* Polyp involving the anal verge
* Polyp inside the ileo-cecal valvula
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Michele Tedeschi
MD
Locations
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IRCCS Humanitas Research Hospital
Rozzano, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Koyama Y, Fukuzawa M, Aikawa H, Nemoto D, Muramatsu T, Matsumoto T, Uchida K, Madarame A, Morise T, Yamaguchi H, Kono S, Nagata N, Sugimoto M, Kawai T, Saito Y, Itoi T. Underwater endoscopic submucosal dissection for colorectal tumors decreases the incidence of post-electrocoagulation syndrome. J Gastroenterol Hepatol. 2023 Sep;38(9):1566-1575. doi: 10.1111/jgh.16259. Epub 2023 Jun 15.
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.
Capogreco A, Hassan C, De Blasio F, Massimi D, de Sire R, Galtieri PA, Despott EJ, Alkandari A, Bhandari P, Facciorusso A, Maselli R, Repici A. Prophylactic underwater vessel coagulation for submucosal endoscopy. Gut. 2024 Jun 6;73(7):1049-1051. doi: 10.1136/gutjnl-2024-332002. No abstract available.
Despott EJ, Hirayama Y, Lazaridis N, Koukias N, Telese A, Hayashi Y, Miura Y, Yamamoto H, Murino A. Saline immersion therapeutic endoscopy facilitated pocket-creation method for endoscopic submucosal dissection (with video). Gastrointest Endosc. 2019 Mar;89(3):652-653. doi: 10.1016/j.gie.2018.10.005. No abstract available.
Spadaccini M, Fuccio L, Lamonaca L, Frazzoni L, Maselli R, Di Leo M, Galtieri PA, Craviotto V, D'Amico F, Hassan C, Repici A. Underwater EMR for colorectal lesions: a systematic review with meta-analysis (with video). Gastrointest Endosc. 2019 Jun;89(6):1109-1116.e4. doi: 10.1016/j.gie.2018.10.023. Epub 2018 Oct 25.
Tseng CW, Hsieh YH, Lin CC, Koo M, Leung FW. Heat sink effect of underwater polypectomy in a porcine colon model. BMC Gastroenterol. 2021 Oct 27;21(1):406. doi: 10.1186/s12876-021-01985-1.
Lenz L, Martins B, Andrade de Paulo G, Kawaguti FS, Baba ER, Uemura RS, Gusmon CC, Geiger SN, Moura RN, Pennacchi C, Simas de Lima M, Safatle-Ribeiro AV, Hashimoto CL, Ribeiro U, Maluf-Filho F. Underwater versus conventional EMR for nonpedunculated colorectal lesions: a randomized clinical trial. Gastrointest Endosc. 2023 Mar;97(3):549-558. doi: 10.1016/j.gie.2022.10.033. Epub 2022 Oct 26.
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Binmoeller KF, Weilert F, Shah J, Bhat Y, Kane S. "Underwater" EMR without submucosal injection for large sessile colorectal polyps (with video). Gastrointest Endosc. 2012 May;75(5):1086-91. doi: 10.1016/j.gie.2011.12.022. Epub 2012 Feb 25.
Arezzo A, Passera R, Marchese N, Galloro G, Manta R, Cirocchi R. Systematic review and meta-analysis of endoscopic submucosal dissection vs endoscopic mucosal resection for colorectal lesions. United European Gastroenterol J. 2016 Feb;4(1):18-29. doi: 10.1177/2050640615585470. Epub 2015 May 5.
Stephane S, Timothee W, Jeremie A, Raphael O, Martin D, Emmanuelle P, Elodie L, Quentin D, Nikki C, Sonia B, Hugo L, Guillaume G, Romain L, Mathieu P, Sophie G, Jeremie J. Endoscopic submucosal dissection or piecemeal endoscopic mucosal resection for large superficial colorectal lesions: A cost effectiveness study. Clin Res Hepatol Gastroenterol. 2022 Jun-Jul;46(6):101969. doi: 10.1016/j.clinre.2022.101969. Epub 2022 Jun 1.
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Other Identifiers
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ID 4139 Wave-ESD
Identifier Type: -
Identifier Source: org_study_id
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