经内镜黏膜切除术（EMR）热消融与无辅助治疗（RESPECT）后高级无蒂和侧向蔓延型结直肠腺瘤复发的国际随机对照试验方案。
Recurrences of advanced sessile and lateral spreading colorectal adenoma after endoscopic mucosal resection (EMR) thermal ablation versus no adjuvant therapy (RESPECT): a protocol of an international randomized controlled trial.
机构信息
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Radboud Institute for Health Sciences, 6500 HB, Nijmegen, The Netherlands.
Department of General Internal Medicine and Gastroenterology, Evangelical Hospital Düsseldorf, Düsseldorf, Germany.
出版信息
Trials. 2024 Feb 17;25(1):132. doi: 10.1186/s13063-024-07915-2.
BACKGROUND
Nowadays, large benign lateral spreading lesions (LSLs) and sessile polyps in the colorectum are mostly resected by endoscopic mucosal resection (EMR). A major drawback of EMR is the polyp recurrence rate of up to 20%. Snare tip soft coagulation (STSC) is considered an effective technique to reduce recurrence rates. However, clinical trials on STSC have mainly been conducted in expert referral centers. In these studies, polyp recurrence was assessed optically, and additional adjunctive techniques were excluded. In the current trial, we will evaluate the efficacy and safety of STSC in daily practice, by allowing adjunctive techniques during EMR and the use of both optical and histological polyp recurrence to assess recurrences during follow-up.
METHODS
The RESPECT study is a multicenter, parallel-group, international single blinded randomized controlled superiority trial performed in the Netherlands and Germany. A total of 306 patients undergoing piecemeal EMR for LSLs or sessile colorectal polyps sized 20-60 mm will be randomized during the procedure after endoscopic complete polyp resection to the intervention or control group. Post-EMR defects allocated to the intervention group will be treated with thermal ablation with STSC of the entire resection margin. Primary outcome will be polyp recurrence by optical and histological confirmation at the first surveillance colonoscopy after 6 months. Secondary outcomes include technical success and complication rates.
DISCUSSION
The RESPECT study will evaluate if STSC is effective in reducing recurrence rates after piecemeal EMR of large colorectal lesions in daily clinical practice performed by expert and non-expert endoscopists. Moreover, endoscopists will be allowed to use adjunctive techniques to remove remaining adenomatous tissue during the procedure. Finally, adenomatous polyp recurrence during follow-up will be defined by histologic identification.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05121805. Registered on 16 November 2021. Start recruitment: 17 March 2022. Planned completion of recruitment: 31 April 2025.
背景
如今，大肠中较大的侧向扩展病变（LSL）和无蒂息肉大多通过内镜黏膜切除术（EMR）切除。EMR 的一个主要缺点是息肉的复发率高达 20%。圈套尖端电凝（STSC）被认为是降低复发率的有效技术。然而，关于 STSC 的临床试验主要在专家转诊中心进行。在这些研究中，息肉复发是通过光学方法评估的，并且排除了其他辅助技术。在本试验中，我们将通过在 EMR 期间允许使用辅助技术，并通过光学和组织学息肉复发来评估随访期间的复发，来评估 STSC 在日常实践中的疗效和安全性。
方法
RESPECT 研究是一项在荷兰和德国进行的多中心、平行组、国际单盲随机对照优效性试验。总共 306 例接受分片 EMR 治疗的侧向扩展病变或大小为 20-60mm 的无蒂结直肠息肉的患者，在完全内镜下切除息肉后，根据内镜下完全切除息肉后的情况，随机分为干预组或对照组。分配到干预组的 EMR 后缺损将采用 STSC 对整个切除边缘进行热消融治疗。主要结局是在 6 个月后第一次监测结肠镜检查时通过光学和组织学确认的息肉复发。次要结局包括技术成功率和并发症发生率。
讨论
RESPECT 研究将评估在专家和非专家内镜医生进行的日常临床实践中，分片 EMR 治疗大肠大病变后，使用圈套尖端电凝（STSC）是否能有效降低复发率。此外，内镜医生将被允许在手术过程中使用辅助技术切除残留的腺瘤性组织。最后，在随访期间通过组织学鉴定定义腺瘤性息肉复发。
试验注册
ClinicalTrials.gov NCT05121805。于 2021 年 11 月 16 日注册。开始招募：2022 年 3 月 17 日。计划完成招募：2025 年 4 月 31 日。
Zotero 插件