Comparison of Cold and Hot Loop Resection Techniques for the Removal of Medium-sized Benign Colon Tumors

NCT07041255 | Recruiting DMC

• 1 other identifier: 06111985_02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Widespread introduction of high-resolution videocolonoscopy into clinical practice has led to an increase in the detection of epithelial lesions of the colon, a significant portion of which are small (\<10 mm) and miniature (≤5 mm) lesions. According to the literature, 15.6-27% of colon lesions 6-9 mm in size and 4.4-10% of those ≤5 mm are high-risk lesions, i.e. they contain villous structures, foci of severe dysplasia or cancer. One of the methods for removing such lesions is the technique of cold loop polypectomy (CLP), i.e. mechanical removal of the polyp with a loop without the use of electric current. This method is common for colon lesions 4-9 mm in size. (For smaller lesions, a technically simple and effective method of removing them using biopsy forceps is most often used) Jung YS, Park JH, Kim HJ et al. Complete biopsy resection of diminutive polyps. Endoscopy 2013; 45: 1024-9). A number of studies have demonstrated the advantages of the CP technique over standard removal methods. "Cold" polypectomy reduces the incidence of complications associated with thermal effects on the mucous membrane and underlying tissues (Bo-In Lee. Polypectomy of Small Polyps: Technical Updates. IDEN 2016, 280-281). Not only the number of perforations and manifestations of postcoagulation syndrome is reduced (D. von Renteln1, H. Pohl. Polyp Resection - Controversial Practices and Unanswered Questions. Clin Transl Gastroenterol. 2017 Mar; 8(3): e76. doi: 10.1038/ctg.2017.6), but also delayed bleeding: 0% with cold snare removal versus 0.5-14% after classical removal using electric current (Horiuchi A, Nakayama Y et al. 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; T. Kawamura1, Y.Takeuchi A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study) Gut Online First, published on September 28, 2017 as 10.1136/gutjnl-2017-314215) ! It is also important that the removal of polyps with a cold snare takes less time than with a hot one, averaging 18 min. versus 25 min. (Ichise Y1, Horiuchi A, Nakayama Y, Tanaka N. Prospective randomized comparison of cold snare polypectomy and conventional polypectomy for small colorectal polyps. Digestion. 2011;84(1):78-81. doi: 10.1159/000323959. However, there are currently clearly not enough large multicenter prospective randomized studies devoted to the comparison of the efficacy and safety of "standard" and cold polypectomy. The opinion of specialists is also ambiguous regarding the instrumentation that should be used for endoscopic removal of small formations. Some endoscopists believe that the type of polypectomy snare used does not affect the efficacy, completeness and safety of removal of small formations, while others, on the contrary, pay special attention to the use of specially designed small-diameter snare loops, believing that only they are capable of ensuring the removal of formations in a single block in the vast majority of cases. (Horiuchi A, Hosoi K, Kajiyama M, et al. Prospective, randomized comparison of 2 methods of cold snare polypectomy for small colorectalpolyps. Gastrointest Endosc 2015;82:686-92.) The question of the need to inject fluid into the submucosal layer under the removed formation also requires a reasoned answer, given that many researchers skip this stage of the intervention and / or consider it unnecessary Toshiki Yamamoto, Sho Suzuki, Chika Kusano, Kyoko Yakabe, Maho Iwamoto, Hisatomo Ikehara, Takuji Gotoda, Mitsuhiko Moriyama. Histological outcomes between hot and cold snare polypectomy for small colorectal polyps. Saudi J Gastroenterol. 2017 Jul-Aug; 23(4): 246-252. doi: 10.4103/sjg.SJG\_598\_16

Conditions

Benign Colon Tumors

Keywords

cold snare resection; hot snare resection

Outcome Measures

Primary Outcomes (6)

• Radicality of removal

  Based on the pathomorphological report, the radicality of the removal of the epithelial formation by the EMR and ESD methods will be assessed. (R0, R1, Rx)

  1 months after removal

• Duration of the operation

  from the moment of submucosal injection until the complete removal of the formation, the duration of the operation will be recorded

  at the time of the operation

• Intraoperative complications

  During the operation, intraoperative complications that arise are recorded: perforation, bleeding

  at the time of the operation

• Postoperative complications

  Postoperative complications that arise from 1 day to 30 days after removal are assessed: postcoagulation syndrome, bleeding, perforation.

  1 months after removal

• Relapse of education

  The postoperative scar is assessed for the presence of recurrent formation

  12 months after removal

• Successful removal

  Analysis of the possibility of removal and the number of fragments

  at the time of the operation

Study Arms (2)

Cold EMR

EXPERIMENTAL

The time of removal, the number of fragments, complications, its immediate and remote results are assessed,histology result

Procedure: Cold endoscopic mucosal resection; Procedure: Hot endoscopic mucosal resection

Hot EMR

EXPERIMENTAL

The time of removal, the number of fragments, , complications, and immediate and long-term results are assessed,histology result

Procedure: Cold endoscopic mucosal resection; Procedure: Hot endoscopic mucosal resection

Interventions

Cold endoscopic mucosal resection PROCEDURE

3-4 ml of solution is injected into the submucosal layer under the formation. The formation with the surrounding mucous membrane (at least 1 mm from the edge of the formation) is captured with a specialized or standard polypectomy loop available to the operator (depending on the randomization result). The formation is removed by mechanical cutting without using electric current.

Also known as: Cold EMR

Cold EMR; Hot EMR

Hot endoscopic mucosal resection PROCEDURE

3-4 ml of solution is injected into the submucosal layer under the formation. The formation with the surrounding mucous membrane (at least 1 mm from the edge of the formation) is captured with a specialized or standard diathermic polypectomy loop available to the operator (depending on the randomization result). The formation is removed using electric current in the Endocat mode (or its analogue, providing alternating cutting and coagulation under the control of a processor built into the electrical unit). After the formation is removed, the resection site is examined in white light, then virtual chromoscopy (NBI), and then an examination with magnification. The examination results are recorded in the scientific protocol separately, and are assessed as a whole. The criteria for visual removal of the formation within healthy tissues are the absence of visible fragments of the formation. The time of complete cessation of capillary bleeding is recorded.

Also known as: Hot EMR

Cold EMR; Hot EMR

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient with one benign non-invasive epithelial formation of the colon of type Is and II, measuring 10-14 mm
• Age ≥ 18 years.
• Signed informed voluntary consent for colonoscopy and removal of formations using the methods under study.

You may not qualify if:

• Reasonable suspicion of severe dysplasia/cancer, including with submucosal invasion based on the results of preoperative assessment (NICE - 3; JNET - 2b and 3; Kudo - Vi and Vn).
• Colonic lesions less than 10 mm
• Recurrent lesion.
• Presence of widespread malignant tumour in any part of the colon.- Use of other methods of endoscopic removal of the lesion.
• IBD.
• Patient on haemodialysis
• Uncorrectable coagulopathy (INR\> 1.5).
• Refusal to participate in the study.
• General contraindications to endoscopic examination.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Evgeny Gorbachev

Moscow, Russia

RECRUITING

Study Officials

• Evgeny Gorbachev

  Pirogov Russian National Research Medical University

  STUDY CHAIR

Central Study Contacts

Evgeny Fedorov

CONTACT

+74999369980; efedo@mail.ru

Evgeny Gorbachev

CONTACT

+74999369980; doc.fenix@mail.ru

Study Design

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

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: November 25, 2023
• Primary Completion: October 10, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)