跳至主要内容
临床试验/NCT04816292
NCT04816292招募中不适用

A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2024年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
850
试验地点
2
主要终点
Complete resection rate

研究概览

简要总结

Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 19 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps <5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen.

In this randomized controlled trial, the investigators want to compare the complete resection rates of small and intermediate sized colorectal polyps 10-15 mm with CSP and HSP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Indication for colonoscopy
  • at least 1 adenomatous polyp 10-15 mm
  • provided written informed consent

排除标准

  • American Society of Anaesthesiologists class IV or higher
  • florid inflammatory bowel disease
  • emergency indication for colonoscopy
  • haemorrhagic diathesis
  • continued dual antiplatelet therapy
  • continued anticoagulant therapy

结局指标

主要结局

Complete resection rate

时间窗: 6 months

The histological complete resection rate, determined by pathologically negative margins of the specimen and no residual adenomatous material obtained from two/four biopsies of the resection site.

次要结局

  • Rate of immediate bleeding with necessity of haemostasis(During procedure)
  • En-bloc resection rate(During procedure)
  • Rate of impossible resection by CSP(During procedure)
  • Time required for resection(During procedure)
  • Rate of procedure-related adverse events.(6 months)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Veit Phillip

Departement for Interdisciplinary Endoscopy

Technical University of Munich

研究点 (2)

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