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临床试验/NCT05347446
NCT05347446已完成不适用

Hybrid Versus Non-Hybrid Endoscopic Submucosal Dissection for Colorectal Polyps: A Randomized Trial (SHORT-ESD)

AdventHealth10 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2022年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
AdventHealth
入组人数
247
试验地点
10
主要终点
• The primary endpoint is to compare procedural time between hybrid vs non-hybrid ESD.

研究概览

简要总结

This proposed trial will randomize 60 patients with a ≥20 mm large colorectal polyp to either undergo hybrid or non-hybrid ESD. For the primary comparison (hybrid vs non-hybrid ESD), the primary outcome will be procedure time. The study will further examine the safety and efficacy of hybrid ESD compared to non-hybrid ESD and investigate factors that may be associated with resection outcomes.

详细描述

Endoscopic submucosal dissection (ESD) permits the en-bloc resection of colorectal lesions irrespective of size. En-bloc resection, as opposed to piecemeal endoscopic mucosal resection (EMR) of colorectal polyps ≥20 mm, provides a more definitive resection specimen for accurate histopathological assessment, and is associated with a low risk for recurrence1,2.

Current guidelines from the Japan Gastroenterological Endoscopy Society (JGES), the European Society of Gastrointestinal Endoscopy (ESGE), and the American Gastroenterology Association (AGA), recommend ESD as a preferred strategy for superficial colorectal lesions with suspicion for advanced neoplasia or early cancer (e.g. depressed morphology, advanced surface pattern, nongranular laterally spreading tumor [LST-NG], polyps, ≥20 mm in size)3-5. In these cases, ESD procures an ideal pathological specimen for submucosal staging, provides curative intent, and prevents unnecessary surgery for lesions with low risk for lymph node metastasis6 Yet, ESD in the United States and Europe has been primarily restricted to specialized centers for a variety of reasons, notably due to its technical complexity7. Technical difficulty resides primarily in the process of submucosal dissection using endoknives. Maintaining adequate visualization of the dissection plane during ESD is often regarded the rate-limiting step (Figure 1 Non-hybrid ESD). Other factors, including maintaining the endoknife parallel to the dissection plane and accounting for paradoxical scope movements due to patient-related factors (e.g. colon redundancy, peristalsis, breathing movements) represent formidable challenges during colorectal ESD. These technical hurdles can lead to prolonged procedural times and higher risk for adverse events8. Overcoming these barriers is necessary for the safe and widespread adoption of ESD in Western clinical practice.

To reduce the technical difficulty of colorectal ESD, several techniques have been introduced, such as the introduction of traction techniques to assist with the exposure and visualization of the dissection plane during ESD8. However, many of these traction techniques require additional devices, second-hand assistance, and have a learning curve of their own9-12. Hence, many of these methods have not been widely adopted.

Hybrid ESD is a modified ESD technique that uses snare-assisted resection as part of the procedure7. With hybrid ESD, a circumferential mucosal incision followed by limited submucosal dissection is performed. Following this, a snare is placed around the lesion, slowly closed to allow resection by traversing the submucosal space. The main advantage of this method is that it reduces the need for deep submucosal dissection underneath the center of the lesion, which intuitively would reduce procedural time and risk of adverse events. Furthermore, snare resection is a technique that is familiar to most endoscopists in the West.

A recent systematic review and meta-analysis evaluated outcomes between hybrid ESD and conventional ESD for colorectal lesions7. In aggregate, when compared with conventional ESD among over 2000 patients, hybrid ESD was associated with a shorter procedural time (mean difference of 18.5 minutes, p=0.003). The rate of adverse events decreased for hybrid ESD compared with conventional ESD (odds ratio 1.56; p=0.04), but no difference when stratified by perforation rate (odds ratio 1.86; p=0.11) or delayed bleeding (odds ratio 1.15; p=0.7). Conversely, hybrid ESD was associated with a lower rate of en-bloc resection when compared to conventional ESD (odds ratio 0.31; p<0.001)7. There are several limitations with this data. For one, 14 out of the 16 studies included in this analysis were observational in design. Hence, important factors, such as lesion size, endoscopist experience, type of snare, were not accounted for in most of the studies. Notably, the meta-analysis included studies in which hybrid ESD was used as a rescue therapy after failed conventional ESD, which further complicates the interpretability of the results. Furthermore, only 4 studies originated from the West (Europe) and none from the United States, limiting the generalizability of this technique by US endoscopists. In all, high-quality studies evaluating hybrid ESD for colorectal lesions are needed.

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
Double (Participant, Care Provider)

盲法说明

Once the subject is consented and enrolled after intraprocedural confirmation of inclusion and exclusion criteria, the randomization envelope will be opened to assign the subject to either Hybrid ESD or Non-Hybrid ESD.

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

  • Any patient ≥18 years
  • Ability to provide informed consent
  • Patient scheduled to undergo colonoscopy with endoscopic resection of colorectal polyps
  • Non-pedunculated polyps measuring ≥20 mm in lateral diameter by endoscopic estimation

排除标准

  • Age < 18 years
  • Inability to provide informed consent
  • Pedunculated polyps (as defined by Paris classification type Ip)8
  • Lesions < 20 mm in lateral diameter
  • Suspected adenocarcinoma with deep submucosal invasion (e.g. Paris III morphology, Kudo type Vn pit pattern)4,13
  • Previously attempted incomplete endoscopic resection (EMR) of the lesion
  • Uncorrected coagulopathy defined as an elevated INR ≥ 1.5 and/or platelet count < 50,000
  • Any standard contraindication to anesthesia and/or colonoscopy
  • Pregnancy or lactating women

研究组 & 干预措施

Hybrid ESD

Active Comparator

Hybrid ESD is a modified ESD technique that uses snare-assisted resection as part of the procedure. With hybrid ESD, a circumferential mucosal incision followed by limited submucosal dissection is performed. Following this, a snare is placed around the lesion, slowly closed to allow resection by traversing the submucosal space

干预措施: Hybrid ESD (Procedure)

Non-Hybrid ESD

Active Comparator

A partial or complete circumferential mucosal incision will be performed to expose the submucosa around and underneath the polyp. Endoscopic resection will then proceed via conventional ESD, submucosal tunneling or pocket technique.

干预措施: Non-hybrid ESD (Procedure)

结局指标

主要结局

• The primary endpoint is to compare procedural time between hybrid vs non-hybrid ESD.

时间窗: 1 day

The primary endpoint is to compare procedural time between hybrid vs non-hybrid ESD. Procedure time is defined as the time from the beginning of the submucosal injection to completion of the ESD, defined as complete removal of the polyp from the colonic wall and all interventions for any intraprocedural adverse events. Procedure speed will be calculated by diving the area of the resected specimen by the procedure time (cm2/minute). The following formula will be used to calculate the area: π (3.14) x 0.25 x long axis x short axis/procedure time.

次要结局

  • Completeness of resection(1 day)
  • Complete (R0) resection rate(1 day)
  • ESD technical difficulty:(1 day)
  • Incidence of overall severe adverse events(6 months)
  • En-Bloc resection rate(1 day)
  • Polyp recurrence(6 months)
  • Proportion of unremovable polyps(6 months)

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (10)

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