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STSC-HybridAPC Trial

2026년 6월 26일 업데이트: Professor Michael Bourke, Western Sydney Local Health District

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

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

140

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Snare Tip Soft Coagulation (STSC)
Circumferential thermal ablation of the resection margin will be performed using the distal tip of a standard polypectomy snare in soft coagulation mode. The tip will be applied sequentially to the entire visible mucosal defect margin to achieve complete circumferential treatment.
Circumferential thermal ablation of the resection margin will be performed using the distal tip of a standard polypectomy snare in soft coagulation mode. The tip will be applied sequentially to the entire visible mucosal defect margin to achieve complete circumferential treatment.
활성 비교기: Hybrid APC (ERBE)
Circumferential thermal ablation of the resection margin will be performed using Hybrid APC (ERBE) in standard APC mode. The argon plasma beam will be applied sequentially to the entire visible mucosal defect margin to achieve complete circumferential treatment. Electrosurgical settings will be standardized according to unit protocol (effect and wattage predefined for Hybrid APC use).
Circumferential thermal ablation of the resection margin will be performed using Hybrid APC (ERBE) in standard APC mode. The argon plasma beam will be applied sequentially to the entire visible mucosal defect margin to achieve complete circumferential treatment. Electrosurgical settings will be standardized according to unit protocol (effect and wattage predefined for Hybrid APC use).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Net margin ablation time
기간: 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.
during the procedure

2차 결과 측정

결과 측정
측정값 설명
기간
Time (total)
기간: during procedure
Total procedure time (minutes): from first endoscopic view of the lesion to scope withdrawal.
during procedure
Technical success of margin ablation
기간: during procedure
Technical success of margin ablation: completion of circumferential thermal treatment of the entire visible mucosal defect margin as judged by the supervising endoscopist and recorded as yes/no.
during procedure
Instrument exchanges (count)
기간: during procedure
Instrument exchanges (count): number of device exchanges required after completion of EMR to achieve margin ablation.
during procedure
Need for additional haemostatic therapy (yes/no)
기간: during procedure
Need for additional haemostatic therapy (yes/no): including clips, APC outside assigned intervention, injectable agents, or other modalities used for bleeding control.
during procedure
Operator-rated ease of use (VAS 0-10)
기간: during procedure
Operator-rated ease of use (VAS 0-10): recorded immediately post-procedure (0 = very difficult, 10 = very easy)
during procedure
Operator confidence (VAS 0-10)
기간: during procedure
Operator confidence (VAS 0-10): confidence that ablation was complete (0 = not confident, 10 = fully confident).
during procedure
Immediate adverse events
기간: during procedure
Immediate adverse events: intraprocedural and early post-procedural events as per standard definitions (bleeding requiring endoscopic therapy, perforation, post-polypectomy syndrome, unplanned admission). Severity will be graded using an accepted endoscopy AE severity framework (e.g., ASGE lexicon).
during procedure
Cost impact (exploratory)
기간: during procedure
Cost impact (exploratory): incremental procedural cost derived from device utilization (snare tip vs Hybrid APC), number of exchanges, and additional haemostatic devices used.
during procedure
Rate of incomplete STSC margin ablation by trainee operators (yes/no, Arm A only)
기간: during procedure
Rate of incomplete STSC margin ablation by trainee operators (yes/no, Arm A only): proportion of Arm A cases in which the supervising endoscopist judged circumferential margin ablation to be incomplete at the conclusion of the trainee's attempt, necessitating supplementary ablation by the supervisor.
during procedure

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Michael J Bourke, MBBS, WSLHD

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 1일

기본 완료 (추정된)

2027년 8월 1일

연구 완료 (추정된)

2027년 8월 15일

연구 등록 날짜

최초 제출

2026년 6월 26일

QC 기준을 충족하는 최초 제출

2026년 6월 26일

처음 게시됨 (실제)

2026년 7월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 26일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2026/PID01713

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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