NCT04593407|Active Not Recruiting
Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.
intERsection
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intERsection
Sponsor study identifier
interventional
236
1 country
1
Study Start
December 1, 2020
Actual (reported)Primary Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
EMR and ESD are both effective and safe and are associated with a very low risk of procedure related mortality when performed for colorectal laterally spreading lesions (LSL). Some kind of LSLs have a low risk of submucosal invasive carcinoma (SMIC) or these foci are found in well demarcated areas of the tumor. This is the case of the non-granular flat elevated (LSN-NG-FE) and the LSLs-G mixed subtypes. The investigators aim to assess if piecemeal EMR (the older technique) for LSLs-G mixed type \> 30 mm and LSLs-NG FE type \> 20 mm is not inferior to ESD (the new treatment) for the need of additional surgery in the mid-term.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 13, 2020
Actual (reported)October 20, 2020
Actual (reported)December 1, 2020
Actual (reported)January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percentage of surgical referral after treatment
Compare between two groups.
Month 18
En bloc resection rate
Month 1
R0 resection rate
Month 1
Duration of the procedure
Month 1
Piecemeal EMR is a conventional endoscopic resection technique. A submucosal injection of a large volume of a solution (normal saline or other) with or without dilute epinephrine (1/10,000) with or without indigo carmine is performed. Then, sequential piecemeal resection is performed with use of a combination of stiff-type snares. At the end of the procedure when macroscopically visible adenoma has been totally resected, a snare tip soft coagulation (STSC) of the margin of the scar is performed to eliminate non visible residual neoplastic tissue. This procedure is quicker and safer than ESD but led to more recurrent disease (around 20% with the standard technique but recently reduced to 5% after the introduction of STSC)
ESD is a newer resection technique that allows en bloc resection for large LSLs. A submucosal injection is also needed but, in this case, different endo-knives are used to achieve the resection instead of diathermic snares. The en bloc resection allows a more precise pathological analysis and the risk of recurrence is lower (\<2%) when margins are tumor-free.
Endoscopic mucosal resection (EMR) is an endoscopic resection technique that allows the removal of large colorectal lesions using a conventional "lift-and-cut" procedure or an underwater technique
Endoscopic submucosal dissection (ESD) is an endoscopic procedure that allows dissection of larger colorectal lesions in one piece using endoknives. The procedure is technically more difficult, much more time-consuming than EMR, mandates multiday hospital admission and has an increased risk of perforation.
Hospital Universitario "12 de Octubre"
Madrid, 28041, Spain
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José C. Marín-Gabriel, Assoc. Prof.
Hospital Universitario 12 de Octubre
First Submitted
October 13, 2020
First Posted
October 20, 2020
Study Start
December 1, 2020
Actual (reported)Primary Completion
January 31, 2027
EstimatedEvaluating the Safety and Effectiveness of the Flex Robotic System for the Surgical Removal of Colorectal Lesions
Percentage of curative resection rates without surgery
Month 18
Proportion of cases in which the endoscopist has to change technique to the alternative procedure
Month 1
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Oyama T, Yahagi N, Ponchon T, Kiesslich T, Berr F. How to establish endoscopic submucosal dissection in Western countries. World J Gastroenterol. 2015 Oct 28;21(40):11209-20. doi: 10.3748/wjg.v21.i40.11209.
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Oka S, Tanaka S, Kanao H, Oba S, Chayama K. Therapeutic strategy for colorectal laterally spreading tumor. Dig Endosc. 2009 Jul;21 Suppl 1:S43-6. doi: 10.1111/j.1443-1661.2009.00869.x.
Saito Y, Uraoka T, Yamaguchi Y, Hotta K, Sakamoto N, Ikematsu H, Fukuzawa M, Kobayashi N, Nasu J, Michida T, Yoshida S, Ikehara H, Otake Y, Nakajima T, Matsuda T, Saito D. A prospective, multicenter study of 1111 colorectal endoscopic submucosal dissections (with video). Gastrointest Endosc. 2010 Dec;72(6):1217-25. doi: 10.1016/j.gie.2010.08.004. Epub 2010 Oct 27.
Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
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Thoguluva Chandrasekar V, Spadaccini M, Aziz M, Maselli R, Hassan S, Fuccio L, Duvvuri A, Frazzoni L, Desai M, Fugazza A, Jegadeesan R, Colombo M, Dasari CS, Hassan C, Sharma P, Repici A. Cold snare endoscopic resection of nonpedunculated colorectal polyps larger than 10 mm: a systematic review and pooled-analysis. Gastrointest Endosc. 2019 May;89(5):929-936.e3. doi: 10.1016/j.gie.2018.12.022. Epub 2019 Jan 9.
Bahin FF, Heitman SJ, Rasouli KN, Mahajan H, McLeod D, Lee EYT, Williams SJ, Bourke MJ. Wide-field endoscopic mucosal resection versus endoscopic submucosal dissection for laterally spreading colorectal lesions: a cost-effectiveness analysis. Gut. 2018 Nov;67(11):1965-1973. doi: 10.1136/gutjnl-2017-313823. Epub 2017 Oct 7.
Yamada M, Saito Y, Sakamoto T, Nakajima T, Kushima R, Parra-Blanco A, Matsuda T. Endoscopic predictors of deep submucosal invasion in colorectal laterally spreading tumors. Endoscopy. 2016 May;48(5):456-64. doi: 10.1055/s-0042-100453. Epub 2016 Feb 26.
Bogie RMM, Veldman MHJ, Snijders LARS, Winkens B, Kaltenbach T, Masclee AAM, Matsuda T, Rondagh EJA, Soetikno R, Tanaka S, Chiu HM, Sanduleanu-Dascalescu S. Endoscopic subtypes of colorectal laterally spreading tumors (LSTs) and the risk of submucosal invasion: a meta-analysis. Endoscopy. 2018 Mar;50(3):263-282. doi: 10.1055/s-0043-121144. Epub 2017 Nov 27.
Tate DJ, Awadie H, Bahin FF, Desomer L, Lee R, Heitman SJ, Goodrick K, Bourke MJ. Wide-field piecemeal cold snare polypectomy of large sessile serrated polyps without a submucosal injection is safe. Endoscopy. 2018 Mar;50(3):248-252. doi: 10.1055/s-0043-121219. Epub 2017 Nov 23.
Gupta S, Miskovic D, Bhandari P, Dolwani S, McKaig B, Pullan R, Rembacken B, Riley S, Rutter MD, Suzuki N, Tsiamoulos Z, Valori R, Vance ME, Faiz OD, Saunders BP, Thomas-Gibson S. A novel method for determining the difficulty of colonoscopic polypectomy. Frontline Gastroenterol. 2013 Oct;4(4):244-248. doi: 10.1136/flgastro-2013-100331. Epub 2013 Jun 1.
Klein A, Tate DJ, Jayasekeran V, Hourigan L, Singh R, Brown G, Bahin FF, Burgess N, Williams SJ, Lee E, Sidhu M, Byth K, Bourke MJ. Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection. Gastroenterology. 2019 Feb;156(3):604-613.e3. doi: 10.1053/j.gastro.2018.10.003. Epub 2018 Oct 6.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 18, 2026
Record last verified: 2026-09
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