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临床试验/NCT07041255
NCT07041255招募中不适用

The First Prospective Randomized Trial Comparing Cold and Hot Loop Resection for Removal of Medium-sized Benign Colon Tumors in Moscow, Russia.

Pirogov Russian National Research Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Radicality of removal

研究概览

简要总结

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

详细描述

Objective of the study: to prospectively compare the immediate, short-term and long-term results of cold and hot resection of the mucosa through a colonoscope, performed for non-invasive medium-sized (10-14 mm) epithelial lesions of the colon with a broad base.

Study objectives:

  1. To evaluate the accuracy of high-resolution colonoscopy in white and narrow spectrum light with magnification in predicting the histological structure of medium-sized epithelial lesions of the colon with a broad base.
  2. To conduct a comparative assessment of the completeness (in one block/in parts; R0/R1) and depth of resection of medium-sized epithelial lesions of the colon with a broad base according to endoscopic and morphological criteria.
  3. To determine the comparative frequency of intra- and postoperative complications (bleeding, perforation, postcoagulation syndrome) during removal of medium-sized epithelial lesions of the colon with a broad base.

General characteristics of the clinical study. Design: prospective, randomized, controlled, single-center study.

It is planned to include at least 200 patients in the study until statistically significant indicators are obtained for all analyzed parameters, who will undergo Cold EMR or Hot EMR for one or more medium-sized (10-14 mm) non-invasive epithelial formations of the colon on a broad base.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.
  • Patient on haemodialysis
  • Uncorrectable coagulopathy (INR> 1.5).
  • Refusal to participate in the study.
  • General contraindications to endoscopic examination.

结局指标

主要结局

Radicality of removal

时间窗: 1 months after 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)

Duration of the operation

时间窗: at the time of the operation

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

Intraoperative complications

时间窗: at the time of the operation

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

Postoperative complications

时间窗: 1 months after removal

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

Relapse of education

时间窗: 12 months after removal

The postoperative scar is assessed for the presence of recurrent formation

Successful removal

时间窗: at the time of the operation

Analysis of the possibility of removal and the number of fragments

次要结局

未报告次要终点

研究者

发起方
Pirogov Russian National Research Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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