Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions
NCT ID: NCT04418843
Last Updated: 2023-09-28
Study Results
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Basic Information
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COMPLETED
NA
229 participants
INTERVENTIONAL
2020-06-08
2023-03-31
Brief Summary
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Detailed Description
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Usually, colon lesions larger than 10 mm (or pedunculated of any size) require for resection the use of electrocoagulation current (or hot snare polypectomy) and thus is reflected in the most recent clinical practice guidelines (ESGE guidelines, for example). However, the risk of side adverse effects from the use of electrocoagulation is not insignificant and includes post-polypectomy bleeding, post-polypectomy syndrome, post-polypectomy fever and/or immediate or delayed perforation. This risk of complications is higher depending on the characteristics and size of colorectal lesions resected.
On the other hand, currently in small lesions not pedunculated (\< 10 mm), it is recommended to use cold snare polypectomy according to ESGE clinical guidelines, as it has been seen in previous studies that this reduces complication rates without varying the effectiveness in resection.
However, in lesions \> 10 mm the previous experience with cold snare resection is less, probably motivated by the possible drawbacks in terms of the possible difficulty of resection of thick tissue with cold snare and a possible increased intra-procedure hemorrhagic risk that can make it difficult to see the scar, with the possibility of leaving residual tissue.
However, in recent years the accumulated evidence gathered in various studies and grouped in a recent systematic review suggests that endoscopic mucosal resection with cold snare (Cold-EMR) may be safer than electrocoagulation resection for both 10-19mm lesions and for lesions \>20 mm, associated with a lower rate of adverse effects with similar efficacy rates in terms of complete resection and adenomatous recurrence rate. Still, evidence for the treatment of nonpedunculated lesions \>20 mm is relatively limited and is not based on randomized comparative studies with the standard EMR technique.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Endoscopic Mucosal Resection
Standard Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (\>20 mm)
Standard Endoscopic Mucosal Resection
Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery
Cold Snare Endoscopic Mucosal Resection
Cold Snare Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (\>20 mm)
Cold Snare Endoscopic Mucosal Resection
Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery
Interventions
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Standard Endoscopic Mucosal Resection
Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery
Cold Snare Endoscopic Mucosal Resection
Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Signature of informed consent of endoscopic exploration
* .No signature of informed consent prior to the study procedure.
* Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations (BSG and ESGE guidelines)
* Patients with severe thrombopenia/ coagulopathy (Platelets \< 50,000/INR \> 1.5) not corrected prior to procedure (plasma or platelet transfusion)
* Patients not candidates for endoscopic resection of colorectal lesions by comorbidities.
* Pregnant.
* Patients with inflammatory bowel disease (IBD)
* Urgent colonoscopy.
* Poor preparation (BBPS \<2 in the colon segment where the lesion is located)
* Laterally spreading tumors (LST) lesions with non-homogeneous morphology including: sessile polyps (0-Is), pedunculated (0-Ip) and LST lesions with depressed or excavated components (Paris 0-IIc or Paris 0-III), LST granular nodular mixed, LST-G with whole nodular type. In case of doubt depressed component (Paris 0-IIc) or histological borderline lesion (JNET2B), will be excluded from the study.
* Histological prediction of deep invasive or non-subsidiary to endoscopic mucosal resection lesion as a treatment of choice: NICE 3 pattern by inspection with NBI or Kudo V pattern in traditional/electronic chromoendoscopy or Sano IIIA/IIIB pattern
* Endoscopic resection of post-EMR scar level relapses
18 Years
ALL
Yes
Sponsors
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Spanish Society of Digestive Endoscopy
OTHER
Oscar Nogales
OTHER
Responsible Party
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Oscar Nogales
Principal Investigator
Principal Investigators
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Oscar Nogales
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañon
Locations
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Óscar Nogales Rincón
Madrid, , Spain
Countries
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References
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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.
Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
Takeuchi Y, Yamashina T, Matsuura N, Ito T, Fujii M, Nagai K, Matsui F, Akasaka T, Hanaoka N, Higashino K, Iishi H, Ishihara R, Thorlacius H, Uedo N. Feasibility of cold snare polypectomy in Japan: A pilot study. World J Gastrointest Endosc. 2015 Nov 25;7(17):1250-6. doi: 10.4253/wjge.v7.i17.1250.
Aslan F, Camci M, Alper E, Akpinar Z, Arabul M, Celik M, Unsal B. Cold snare polypectomy versus hot snare polypectomy in endoscopic treatment of small polyps. Turk J Gastroenterol. 2014 Jun;25(3):279-83. doi: 10.5152/tjg.2014.5085.
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.
Hirose R, Yoshida N, Murakami T, Ogiso K, Inada Y, Dohi O, Okayama T, Kamada K, Uchiyama K, Handa O, Ishikawa T, Konishi H, Naito Y, Fujita Y, Kishimoto M, Yanagisawa A, Itoh Y. Histopathological analysis of cold snare polypectomy and its indication for colorectal polyps 10-14 mm in diameter. Dig Endosc. 2017 Jul;29(5):594-601. doi: 10.1111/den.12825. Epub 2017 May 17.
Rameshshanker R, Tsiamoulos Z, Latchford A, Moorghen M, Saunders BP. Resection of large sessile serrated polyps by cold piecemeal endoscopic mucosal resection: Serrated COld Piecemeal Endoscopic mucosal resection (SCOPE). Endoscopy. 2018 Jul;50(7):E165-E167. doi: 10.1055/a-0599-0346. Epub 2018 May 9. No abstract available.
Rex KD, Vemulapalli KC, Rex DK. Recurrence rates after EMR of large sessile serrated polyps. Gastrointest Endosc. 2015 Sep;82(3):538-41. doi: 10.1016/j.gie.2015.01.025. Epub 2015 Apr 4.
Qu J, Jian H, Li L, Zhang Y, Feng B, Li Z, Zuo X. Effectiveness and safety of cold versus hot snare polypectomy: A meta-analysis. J Gastroenterol Hepatol. 2019 Jan;34(1):49-58. doi: 10.1111/jgh.14464. Epub 2018 Sep 26.
Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Endoscopy. 2016 Apr;48(4):c1. doi: 10.1055/s-0042-122686. Epub 2017 Jan 23. No abstract available.
Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.
Takayanagi D, Nemoto D, Isohata N, Endo S, Aizawa M, Utano K, Kumamoto K, Hojo H, Lefor AK, Togashi K. Histological Comparison of Cold versus Hot Snare Resections of the Colorectal Mucosa. Dis Colon Rectum. 2018 Aug;61(8):964-970. doi: 10.1097/DCR.0000000000001109.
Rodriguez Sanchez J, Sanchez Alonso M, Pellise Urquiza M. The "bubble sign": a novel way to detect a perforation after cold snare polypectomy. Endoscopy. 2019 Aug;51(8):796-797. doi: 10.1055/a-0881-2856. Epub 2019 May 9. No abstract available.
Keklikkiran C, Ozdogan OC. Thermal ablation of mucosal defect margins reduces adenoma recurrence after colonic endoscopic mucosal resection. Turk J Gastroenterol. 2019 Jun;30(6):580-581. doi: 10.5152/tjg.2019.210519. No abstract available.
Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.
Nogales O, Carbonell Blanco C, Montori Pina S, Pellise M, Martinez Sempere JF, Riu Pons F, Mangas-Sanjuan C, Daca-Alvarez M, Uchima H, Aranda-Hernandez J, Alvarez Delgado A, Rodriguez de Santiago E, Santiago Garcia J, Canete Ruiz A, Miranda Garcia P, Nunez Rodriguez H, Herreros-de-Tejada A, Valdivielso Cortazar E, De Maria P, Busquets D, Elosua A, Rivero-Sanchez L, Lopez-Ibanez M, Alvarez-Gonzalez MA, Albeniz E; Mucosal Resection and Third-Space Endoscopy SEED Working Group. Cold snare endoscopic mucosal resection versus standard hot technique for large flat nonpedunculated colonic lesions: a randomized controlled trial. Endoscopy. 2025 Aug;57(8):851-861. doi: 10.1055/a-2542-9759. Epub 2025 Feb 19.
Other Identifiers
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RMEFRÍA.2019
Identifier Type: -
Identifier Source: org_study_id
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