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临床试验/NCT07682805
NCT07682805尚未招募不适用

Snare Tip Soft Coagulation Versus Hybrid APC (ERBE) for Post-EMR Margin Thermal Ablation - A Prospective Randomized Controlled Trial

Western Sydney Local Health District1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2027年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
试验地点
1
主要终点
Net margin ablation time

研究概览

简要总结

Margin thermal ablation after piecemeal EMR significantly reduces recurrence of large colorectal polyps. As recurrence rates are now low, the key implementation question relates to efficiency and reproducibility of different ablation techniques. This randomized controlled trial compares snare tip soft coagulation (STSC) with Hybrid APC (ERBE), with procedural time as the primary endpoint.

详细描述

Piecemeal endoscopic mucosal resection (EMR) of large (≥20 mm) non-pedunculated colorectal lesions was historically associated with local recurrence rates in the range of 15-20% at first surveillance when no systematic margin therapy was applied¹. The introduction of structured post-EMR margin thermal ablation has substantially altered this landscape. In a landmark randomized controlled trial, systematic thermal ablation of the resection margin reduced recurrence from 21% to 5%². Subsequent prospective and multicenter studies performed in high-volume expert centers using standardized circumferential snare-tip soft coagulation (STSC) protocols have demonstrated further reductions, with reported recurrence rates approaching 1-2%³. Most recently, Gauci et al. demonstrated that complete margin thermal ablation eliminates lesion size as a risk factor for recurrence following piecemeal EMR of large non-pedunculated colorectal polyps, reinforcing the durability and consistency of this approach in contemporary practice⁴. These findings are supported by meta-analytic data confirming that thermal margin ablation significantly reduces recurrence compared with no ablation without increasing clinically meaningful adverse events⁵. Accordingly, current international guidelines strongly recommend routine thermal ablation of the post-EMR mucosal defect margin following piecemeal resection of large colorectal lesions⁶.

Given that recurrence rates are now low when complete circumferential ablation is systematically performed, additional trials powered for recurrence would require prohibitively large sample sizes to detect incremental differences. The remaining clinically relevant gap therefore relates not to efficacy, but to procedural efficiency, reproducibility, and implementation, particularly in early-career or non-advanced interventional endoscopists.

Snare-tip soft coagulation requires precise contact-based application of thermal energy at each point sequentially along the entire resection margin, demanding consistent tip positioning and repeated fine manipulations. This technical precision may be particularly challenging for endoscopists with limited experience, increasing the risk of incomplete ablation or prolonged procedural time.

Hybrid APC (ERBE) delivers thermal energy via a non-contact argon plasma beam with a broader coagulation footprint per activation, potentially enabling faster and more reproducible circumferential coverage with fewer individual applications. The wider energy spread of Hybrid APC may therefore reduce operator-dependent variability and facilitate more consistent margin treatment, particularly in the hands of early-career endoscopists. Whether this translates into a meaningful reduction in net ablation time and improved completion rates compared with STSC has not been prospectively evaluated.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Undergoing piecemeal EMR of a non-pedunculated colorectal lesion ≥20 mm in size
  • Macroscopically complete resection achieved prior to margin ablation (no visible residual adenomatous tissue at the resection base)
  • Ability to provide written informed consent

排除标准

  • Lesions requiring en bloc resection by ESD
  • Lesions with suspected deep submucosal invasion based on endoscopic assessment (e.g., depressed morphology, non-lifting sign, NICE type 3 pattern, or equivalent advanced imaging criteria)
  • Inflammatory bowel disease with active colitis at the lesion site
  • Overt invasive carcinoma requiring surgical management
  • Pregnancy
  • Inability to provide informed consent

结局指标

主要结局

Net margin ablation time

时间窗: during the procedure

Net margin ablation time (seconds), defined as the elapsed time from the first application of thermal energy to the resection margin (first activation in soft coagulation mode) until the operator declares completion of circumferential margin ablation. Time will be recorded using a standardized stopwatch method by a trained assistant/nurse (or captured from time-stamped video, if available). Interruptions unrelated to margin ablation (e.g., equipment troubleshooting) will be documented and excluded from net time where feasible, with sensitivity analyses planned.

次要结局

  • Time (total)(during procedure)
  • Technical success of margin ablation(during procedure)
  • Instrument exchanges (count)(during procedure)
  • Need for additional haemostatic therapy (yes/no)(during procedure)
  • Operator-rated ease of use (VAS 0-10)(during procedure)
  • Operator confidence (VAS 0-10)(during procedure)
  • Immediate adverse events(during procedure)
  • Cost impact (exploratory)(during procedure)
  • Rate of incomplete STSC margin ablation by trainee operators (yes/no, Arm A only)(during procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Michael Bourke

Professor Michael Bourke

Western Sydney Local Health District

研究点 (1)

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