Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas
NCT ID: NCT06217250
Last Updated: 2024-04-18
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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NOT_YET_RECRUITING
NA
330 participants
INTERVENTIONAL
2024-04-15
2026-01-31
Brief Summary
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Detailed Description
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The conventional procedure starts with the initial submucosal infiltration of the submucosal layer using a physiological solution and methylene blue, forming a cushion that facilitates tissue transection with the assistance of a diathermic snare. The goal is to remove the lesions in larger fragments whenever possible.
In contrast, the "cold" procedure, employs a specialized snare that enables tissue transection without the need for electrical current. This approach yields the same outcome as the conventional procedure but offers the advantage of reducing the risks associated with the use of diathermic current. Subsequently, the lesion fragments are retrieved for histological examination.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional EMR
Conventional EMR with thermal ablation of resection margins: initial submucosal injection of saline and methylene blue and subsequent piecemeal resection with 10- or 15-mm diathermic snare with subsequent thermal ablation of resection margins with snare tip soft coagulation.
Traditional EMR
Conventional EMR with thermal ablation of resection margins: initial submucosal injection of saline and methylene blue and subsequent piecemeal resection with 10- or 15-mm diathermic snare with subsequent thermal ablation of resection margins with snare tip soft coagulation.Nevertheless, this technique is associated with the emergence of serious adverse events (SAEs), including delayed bleeding (PPB), electrocautery-induced post-polipectomy syndrome (PPS), and perforation(4).
Underwater Cold EMR
Underwater Cold EMR (CS-EMR): after filling the lumen with water, initial submucosal injection of saline and methylene blue and subsequent piece-meal resection carried out with dedicated cold snare.
the cold snare ("CO"), underwater technique ("W"), and the use of submucosal lift ("L") in both study arms
The "cold-EMR" technique, as opposed to the conventional approach, employs a specialized snare that enables tissue transection without the need for electrical current, particularly in appropriately selected lesions. This approach yields the same efficacy outcome as the conventional procedure but offers the advantage of reducing the risks associated with polypectomy, which are often secondary to the use of diathermic current. Subsequently, the lesion fragments are retrieved for histological examination. Furthermore, the use of underwater setting, as demonstrated for hot EMR, could improve the effectiveness of cold-EMR.
Interventions
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Traditional EMR
Conventional EMR with thermal ablation of resection margins: initial submucosal injection of saline and methylene blue and subsequent piecemeal resection with 10- or 15-mm diathermic snare with subsequent thermal ablation of resection margins with snare tip soft coagulation.Nevertheless, this technique is associated with the emergence of serious adverse events (SAEs), including delayed bleeding (PPB), electrocautery-induced post-polipectomy syndrome (PPS), and perforation(4).
the cold snare ("CO"), underwater technique ("W"), and the use of submucosal lift ("L") in both study arms
The "cold-EMR" technique, as opposed to the conventional approach, employs a specialized snare that enables tissue transection without the need for electrical current, particularly in appropriately selected lesions. This approach yields the same efficacy outcome as the conventional procedure but offers the advantage of reducing the risks associated with polypectomy, which are often secondary to the use of diathermic current. Subsequently, the lesion fragments are retrieved for histological examination. Furthermore, the use of underwater setting, as demonstrated for hot EMR, could improve the effectiveness of cold-EMR.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients who were able to give informed written consent.
Exclusion Criteria
* lesions with large (\>10 mm) Paris 0-Is component that could compromise the nodular en-bloc resection and increase risk of submucosal invasion.
* suspected sessile serrated adenomas (SSAs) according to traditional features such as adherent surface mucus, cloud-like surface, interruption of mucosal vessels, Kudo II-o pit pattern.
* pedunculated polyps
* active/quiescent colitis
* patients with other lesions resected by hot snare during the same procedure.
* rectal lesions
* residual or recurrent adenoma after endoscopic mucosal resection
18 Years
ALL
Yes
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Central Contacts
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References
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Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.
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.
Sidhu M, Shahidi N, Gupta S, Desomer L, Vosko S, Arnout van Hattem W, Hourigan LF, Lee EYT, Moss A, Raftopoulos S, Heitman SJ, Williams SJ, Zanati S, Tate DJ, Burgess N, Bourke MJ. Outcomes of Thermal Ablation of the Mucosal Defect Margin After Endoscopic Mucosal Resection: A Prospective, International, Multicenter Trial of 1000 Large Nonpedunculated Colorectal Polyps. Gastroenterology. 2021 Jul;161(1):163-170.e3. doi: 10.1053/j.gastro.2021.03.044. Epub 2021 Mar 31.
Russo P, Barbeiro S, Awadie H, Libanio D, Dinis-Ribeiro M, Bourke M. Management of colorectal laterally spreading tumors: a systematic review and meta-analysis. Endosc Int Open. 2019 Feb;7(2):E239-E259. doi: 10.1055/a-0732-487. Epub 2019 Jan 30.
Thoguluva Chandrasekar V, Aziz M, Patel HK, Sidhu N, Duvvuri A, Dasari C, Kennedy KF, Ashwath A, Spadaccini M, Desai M, Jegadeesan R, Sathyamurthy A, Vennalaganti P, Kohli D, Hassan C, Pellise M, Repici A, Sharma P, Bourke MJ. Efficacy and Safety of Endoscopic Resection of Sessile Serrated Polyps 10 mm or Larger: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2448-2455.e3. doi: 10.1016/j.cgh.2019.11.041. Epub 2019 Nov 29.
Spadaccini M, Alfarone L, Facciorusso A, Gkolfakis P, Thoguluva Chandrasekar V, Fugazza A, Colombo M, Capogreco A, Massimi D, Carrara S, Alkandari A, Bhandari P, Maselli R, Hassan C, Repici A. Cold-snare endoscopic resection of non-ampullary duodenal adenomas: Systematic review and pooled-analysis. Dig Liver Dis. 2024 Apr;56(4):656-662. doi: 10.1016/j.dld.2023.09.013. Epub 2023 Sep 28.
Ito A, Suga T, Ota H, Tateiwa N, Matsumoto A, Tanaka E. Resection depth and layer of cold snare polypectomy versus endoscopic mucosal resection. J Gastroenterol. 2018 Nov;53(11):1171-1178. doi: 10.1007/s00535-018-1446-2. Epub 2018 Mar 7.
Suresh S, Zhang J, Ahmed A, Abu Ghanimeh M, Elbanna A, Kaur R, Isseh M, Watson A, Dang DT, Chathadi KV, Pompa R, Singla S, Piraka C, Zuchelli T. Risk factors associated with adenoma recurrence following cold snare endoscopic mucosal resection of polyps >/= 20 mm: a retrospective chart review. Endosc Int Open. 2021 Jun;9(6):E867-E873. doi: 10.1055/a-1399-8398. Epub 2021 May 27.
Maruoka D, Kishimoto T, Matsumura T, Arai M, Akizue N, Ishikawa K, Ohta Y, Kasamatsu S, Taida T, Ishigami H, Okimoto K, Saito K, Nakagawa T, Kato N. Underwater cold snare polypectomy for colorectal adenomas. Dig Endosc. 2019 Nov;31(6):662-671. doi: 10.1111/den.13427. Epub 2019 May 27.
Forbes N, Gupta S, Frehlich L, Meng ZW, Ruan Y, Montori S, Chebaa BR, Dunbar KB, Heitman SJ, Feagins LA, Albeniz E, Pohl H, Bourke MJ. Clip closure to prevent adverse events after EMR of proximal large nonpedunculated colorectal polyps: meta-analysis of individual patient data from randomized controlled trials. Gastrointest Endosc. 2022 Nov;96(5):721-731.e2. doi: 10.1016/j.gie.2022.05.020. Epub 2022 Jun 3.
Rotermund C, Djinbachian R, Taghiakbari M, Enderle MD, Eickhoff A, von Renteln D. Recurrence rates after endoscopic resection of large colorectal polyps: A systematic review and meta-analysis. World J Gastroenterol. 2022 Aug 7;28(29):4007-4018. doi: 10.3748/wjg.v28.i29.4007.
Rex DK, Anderson JC, Pohl H, Lahr RE, Judd S, Antaki F, Lilley K, Castelluccio PF, Vemulapalli KC. Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2022 Aug;96(2):330-338. doi: 10.1016/j.gie.2022.03.006. Epub 2022 Mar 12.
Other Identifiers
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COWL
Identifier Type: -
Identifier Source: org_study_id
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