Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT07041255

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

Led by Pirogov Russian National Research Medical University · Updated on 2025-06-27

200

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with one benign non-invasive epithelial colon lesion of type Is or II, measuring 10-14 mm
  • Age 18 years or older
  • Signed informed voluntary consent for colonoscopy and lesion removal using the study methods
Not Eligible

You will not qualify if you...

  • Suspicion of severe dysplasia or cancer including submucosal invasion based on preoperative assessment
  • Colon lesions smaller than 10 mm
  • Recurrent lesion
  • Presence of widespread malignant tumor anywhere in the colon
  • Use of other endoscopic removal methods
  • Inflammatory bowel disease (IBD)
  • Patient on hemodialysis
  • Uncorrectable coagulopathy (INR > 1.5)
  • Refusal to participate in the study
  • General contraindications to endoscopic examination

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Evgeny Gorbachev

Moscow, Russia

Actively Recruiting

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Research Team

E

Evgeny Fedorov

CONTACT

E

Evgeny Gorbachev

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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