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内镜下粘膜切除大无蒂结直肠息肉后预防性双重热消融和完全闭合:一项随机对照试验 (ABLATION)

大型无蒂结直肠息肉内镜粘膜切除术后预防性双热消融和完全闭合:随机对照试验 - (HAPC-RCT)

Large (≥20mm) colorectal polyps often harbor areas of advanced neoplasia, making them immediate colorectal cancer (CRC) precursors. Such polyps have to be completely removed to prevent CRC and to avoid surgery and/or adjuvant therapy. The laterally spreading lesions (LSLs) are removed via endoscopic mucosal resection (EMR). However, recurrence is common. New techniques for LSL resection (hybrid argon plasma coagulation (h-APC) margin and base ablation) have shown a reduction in recurrence following the interventions.

We hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation during EMR of large (≥20mm) colorectal LSLs will lead to lower rates of lesion recurrence compared to Snare tip soft coagulation (STSC) margin ablation.

研究概览

详细说明

This trial is an open-label, two-arm, parallel-group, multicenter, randomized controlled superiority trial. Patients undergoing EMR will be randomly assigned in a 1:1 ratio to undergo additional STSC margin ablation (control group and current standard of care) or h-APC ablation of the margins and base (experimental group).

Patients will be enrolled in the study before the endoscopy procedure, or in the outpatient clinic.

Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation regimen before their scheduled procedure.

EMR intervention will be performed for all eligible patients with a large laterally spreading lesions (LSLs) by expert endoscopists. Only if a polyp meets inclusion criteria, the study subject will be enrolled and randomized into one of these 2 groups:

  • Group 1: EMR + h-APC margin and base thermal ablation
  • Group 2: EMR + STSC of the margin

The standard EMR technique will be used for the primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection will be used as per the current standard of care using a contrast agent and a lifting agent (e.g., NaCl 0.9% or Voluven). Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery. If residual polyp tissue cannot be removed by a snare, other means such as cold snare (i.e., for small residual polyp tissue that cannot be engaged into standard snares) or avulsive methods will be used. Randomization will be performed after resection is complete and before thermal ablation. After the complete removal of the polyp, depending on the randomization group, h-APC or STSC techniques will be used for margin and base or only margin ablation of the post-EMR defect.

If multiple large polyps are found and removed, the study polyp will be marked with two tattoos 3 cm distal and 3 cm proximal to the lesion, to clearly identify the study polyp associated scar in the follow-up colonoscopy. Polyps will be sent to the pathology lab and evaluated according to standard practice by institutional pathologists. To determine the homogeneity and depth of h-APC margin ablation in the pathology lab, some ablated margins might be resected using the standard cold snare technique.

Telephone calls after 14 days following the EMR will be conducted to assess possible adverse events that occurred within the first 14 days after EMR.

Follow-up 1: Surveillance colonoscopy occurring 6 months after the EMR intervention for the assessment of recurrence (biopsy from the post-EMR site to be confirmed by pathology) following the intervention (h-APC) and the control (STSC) techniques.

Follow-up 2: Surveillance colonoscopy at 18 months (± 6 months) after the EMR intervention for the assessment of recurrence (biopsy from the post-EMR site to be confirmed by pathology) at FU1.

Patients with visible recurrence at the EMR site will undergo additional resection for complete eradication of recurrence. Patients with no visible but pathology-confirmed recurrence will be rescheduled for another colonoscopy with subsequent treatment of the post-EMR site and another follow-up colonoscopy for biopsies and confirmation of complete/incomplete eradication within 18 months after the initial EMR.

研究类型

介入性

注册 (估计的)

892

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Quebec
      • Montreal、Quebec、加拿大
        • 招聘中
        • Centre Hospitalier de l'Université de Montréal
        • 首席研究员:
          • Daniel Von Renteln, MD
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • adult ≥18 years old
  • patients undergoing EMR for a large (≥20mm) colorectal LSL
  • patients providing written and informed consent for study participation.

Exclusion Criteria:

  • inflammatory bowel disease;
  • non-elective colonoscopy;
  • poor general health (American Society of Anesthesiologists classification >III);
  • coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets <50 x 109/L);
  • pedunculated polyps (Paris class Ip, Isp);
  • overt signs of deep submucosal invasive cancer (JNET 3);
  • biopsy proven invasive carcinoma in a potential study polyp.
  • Pregnant women

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Endoscopic Mucosal Resection (EMR)+Hybrid Argon Plasma Coagulation (h-APC)

Standard endoscopic mucosal resection (EMR) technique will be used for the primary removal of all polyps, utilizing submucosal injection. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery (e.g., ERBE VIO Endocut 3-1-6). Ablation of the margin and base of the polypectomy site will be performed using Hybrid Argon Plasma Coagulation (h-APC, Erbe Hybrid APC).

The hybrid argon plasma coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows for the lifting of dysplastic epithelium, creating a cushion under the mucosa to facilitate the ablation of larger areas more thoroughly and with higher energy settings, while posing a low risk for side effects or complications.

其他名称:
  • h-APC
有源比较器:Endoscopic Mucosal Resection (EMR) + Snare tip soft coagulation (STSC)

Standard endoscopic mucosal resection (EMR) technique will be used for the primary removal of all polyps, utilizing submucosal injection. Electrocautery snare technique will be facilitated using standard microprocessor-controlled electrocautery (e.g., ERBE VIO Endocut 3-1-6). Ablation of the margin of the polypectomy site will be performed using Snare tip soft coagulation (STSC).

The Snare tip soft coagulation (STSC) involves using a snare to remove polyps, while simultaneously applying soft coagulation to the surrounding tissue using a specialized tip on the snare.

其他名称:
  • STSC

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Recurrence after colorectal EMR between the h-APC and STSC methods
大体时间:4 years

Lesion recurrence at first follow-up after EMR of large (≥20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. Defined by visual recurrence or pathology-confirmed hyperplastic, serrated or adenomatous histology of the same histology of the index lesion at the tattooed resection site on at least one of four random biopsies of resection scars. These will be evaluated from an intention to treat and per protocol standpoint.

4 years

次要结果测量

结果测量
措施说明
大体时间
Adverse event rates after EMR with STSC or h-APC
大体时间:4 years

Adverse event rates after EMR of large (≥20mm) colorectal LSLs when performing EMR with STSC margin ablation or h-APC margin and base ablation. Defined as either a) delayed bleeding (defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention) or b) delayed perforation (defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract). These will be evaluated from an intention to treat and per protocol standpoint.

4 years
Technical success of STSC or h-APC
大体时间:4 years

Technical success of STSC or h-APC defined as achieving a complete uninterrupted ring ofcircumferential margin ablation for STSC and h-APC, without crossover to complete the margin ablation, and achieving 100% surface ablation of the resection base for h-APC.

4 years
Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC
大体时间:4 years

Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC

4 years
High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period.
大体时间:4 years

High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period at the resection site.

4 years
CRC occurrence during the 18-month follow-up period
大体时间:4 years

CRC occurrence after EMR during the 18-month follow-up period

4 years

其他结果措施

结果测量
措施说明
大体时间
STSC 或 h-APC 消融时间
大体时间:4年
4年
失访
大体时间:4年
4年
缺陷闭合时间
大体时间:4年
4年
与程序相关的费用
大体时间:4年
4年
Colonoscopies required to achieve lesion clearance after EMR with STSC or h-APC
大体时间:4 years

Colonoscopies required to achieve lesion clearance, defined as no histologic recurrence at the resection scar on follow-up.

4 years
EMR procedure time
大体时间:4 years

EMR procedure time with STSC or h-APC

4 years
Intestinal preservation 18 months after ablation
大体时间:4 years

Defined as no surgical resection performed.

4 years
Clinically significant delayed bleeding in the proximal colon after EMR with STSC or h-APC
大体时间:14 days

Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention. Proximal defined as proximal to the splenic flexure.

14 days
Clinically significant delayed bleeding in the distal colon after EMR with STSC or h-APC
大体时间:14 days

Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention. Distal defined as splenic flexure and distal.

14 days
Clinically significant delayed bleeding in the entire colon after EMR with STSC or h-APC
大体时间:14 days

Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention.

14 days
Delayed perforation after EMR with STSC or h-APC
大体时间:14 days

Delayed perforation defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract

14 days
Any delayed bleeding after EMR
大体时间:14 days

Any delayed bleeding after EMR, defined as blood per rectum after the procedure

14 days
Technical success for complete defect closure
大体时间:4 years

Defined as adequate apposition of the mucosal defect margins without visible submucosal areas >3 mm along the closure line.

4 years
Factors associated with recurrence after colorectal EMR between the h-APC and STSC methods
大体时间:4 years

Lesion recurrence at first follow-up after EMR of large (≥20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. Defined by pathology-confirmed hyperplastic, serrated or adenomatous histology of the same histology of the index lesion at the tattooed resection site on at least one of four random biopsies of resection scars. Factors such as age, sex, lesion size (20-29mm, ≥30mm; 20-39mm, ≥40mm), histology, location, difficulty (difficult defined as peri-appendiceal, on the ileocecal valve, resection previously attempted and failed by a referring endoscopist), use of epinephrine in submucosal injection, submucosal lifting solution, resection type (en bloc [i.e. in one piece] vs piecemeal), technical success, study site, endoscopist yearly EMR volume, presence of intraprocedural bleeding, utilization of adjunct resection methods, ileocecal or anus involvement, polyp histology/morphology will be evaluated.

4 years
Factors associated with adverse event rates after EMR with STSC or h-APC
大体时间:30 days

Adverse event rates after EMR of large (≥20mm) colorectal LSLs when performing EMR with STSC margin ablation or h-APC margin and base ablation. Defined as either a) delayed bleeding (defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention) or b) delayed perforation (defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract). Factors such as age, sex, lesion size, morphology, histology, location, complete/incomplete/no defect closure, prophylactic vessel ablation, base ablation, anticoagulant use will be evaluated

30 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月19日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2028年4月1日

研究注册日期

首次提交

2024年2月15日

首先提交符合 QC 标准的

2024年2月15日

首次发布 (实际的)

2024年2月22日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).

IPD 共享时间框架

Beginning 12 months and ending 36 months following article publication.

IPD 共享访问标准

Proposals should be directed to daniel.von.renteln.med@ssss.gouv.qc.ca . To gain access, data requestors will need to sign a data access agreement

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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