Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions

NCT04418843 | Completed DMC

• 1 other identifier: RMEFRÍA.2019
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the effectiveness in complete resection (absence of recurrence at 6 months) the two different techniques for performing endoscopic mucosal resection (EMR) of nonpedunculated homogeneous colorectal lesions \>20mm

Conditions

Adenoma Colon; Serrated Polyp; Serrated Adenoma; Colorectal Neoplasms

Keywords

endoscopic mucosal resection; cold snare endoscopic mucosal resection; standard endoscopic mucosal resection; large nonpedunculated homogeneous colorectal lesions; adenoma colon; serrated polyp; serrated adenoma; conventional endoscopic mucosal resection; laterally spreading adenomas.

Outcome Measures

Primary Outcomes (1)

• Complete resection of the lesion

  Complete resection of the lesion is defined as the non-visualization by the endoscopist of a residual lesion in the mucosal defect and its edge at the end of the EMR and no visualization of recurrence in the post-EMR scar on the first surveillance colonoscopy and absence of recurrence data in scar biopsies

  3-6 months

Secondary Outcomes (15)

• Security profile

  30 days

• Late adenoma recurrence rate

  18 months

• Number of fragments needed to complete the resection

  1 day

• Resection time

  1 day

• Bloc resection rate

  1

Study Arms (2)

Standard Endoscopic Mucosal Resection

EXPERIMENTAL

Standard Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (\>20 mm)

Procedure: Standard Endoscopic Mucosal Resection

Cold Snare Endoscopic Mucosal Resection

EXPERIMENTAL

Cold Snare Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (\>20 mm)

Procedure: Cold Snare Endoscopic Mucosal Resection

Interventions

Standard Endoscopic Mucosal Resection PROCEDURE

Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery

Also known as: Standard EMR

Standard Endoscopic Mucosal Resection

Cold Snare Endoscopic Mucosal Resection PROCEDURE

Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery

Also known as: Cold EMR

Cold Snare Endoscopic Mucosal Resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Nonpedunculated homogeneous colorectal lesions type LST ( Paris 0-IIa morphology) and serrated lesions larger than 20 mm without endoscopic data of malignancy: NICE 1 pattern +/- NICE 2 component ( serrated lesions) or NICE2 pattern/JNET 2A (adenomas) and therefore subsidiaries of RME. Randomization will be performed per patient, not for colorectal lesions
• 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

Sponsors & Collaborators

• Oscar Nogales: lead
• Spanish Society of Digestive Endoscopy: collaborator

Study Sites (1)

Óscar Nogales Rincón

Madrid, 28007, Spain

Location

Related Publications (16)

• 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.

  PMID: 30639542 BACKGROUND

• 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.

  PMID: 24125514 BACKGROUND

• 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.

  PMID: 26634041 BACKGROUND

• 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.

  PMID: 25141316 BACKGROUND

• 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.

  PMID: 29169195 BACKGROUND

• 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.

  PMID: 28160332 BACKGROUND

• 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.

  PMID: 29742770 BACKGROUND

• 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.

  PMID: 25851161 BACKGROUND

• 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.

  PMID: 30176072 BACKGROUND

• 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.

  PMID: 28114689 BACKGROUND

• 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.

  PMID: 27464708 BACKGROUND

• 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.

  PMID: 29944582 BACKGROUND

• 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.

  PMID: 31071753 BACKGROUND

• 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.

  PMID: 31144663 BACKGROUND

• 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.

  PMID: 24986245 BACKGROUND

• 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.

  PMID: 39970943 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Oscar Nogales

  Hospital General Universitario Gregorio Marañon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized study (1:1), multicenter, non-blind of consecutive non-pedunculated lesions of serrated and adenomatous histology, homogeneous, with a size greater than or equal to 20 mm (no upper limit in size). Performing cold-EMR vs standard EMR. A non-inferiority study of cold-EMR versus standard EMR.

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: June 8, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)