Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Post-EMR recurrence at FU1
研究概览
简要总结
Endoscopic Mucosal Resection (EMR) is the current standard for effective endoscopic resection of such colon adenomas. If resection is possible in one piece (so-called "en bloc" resection) then recurrence rates are low. However, most non-pedunculated polyps >2 cm are removed in pieces ("piece-meal" resection) which leads to disease recurrence rates between 12-30%. In the March 2019 issue of Gastroenterology Bourke et al. presented that post-EMR ablation of the resection margins using soft coagulation with the tip of a resection snare reduces adenoma recurrence to 5% compared to 21% recurrence found in the control group. 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 to lift of dysplastic epithelium thus creating a safety cushion under the mucosa is lifted with a saline injection and then to ablate larger areas more thoroughly and with a higher energy setting, with a low risk for side effects or complications.
The study hypothesis is that routine use of hybrid Argon Plasma Coagulation (h-APC) for ablation of the post-EMR resection margins and resection surface area will reduce post-EMR adenoma recurrence to 5% or lower.
详细描述
This is a prospective, multi-center study enrolling patients with non-pedunculated colorectal polyps ≥ 20mm for endoscopic mucosal resection (EMR). All primary EMR procedures will combine EMR with h-APC ablation of the base and margins after complete EMR resection to prevent adenoma recurrence.
Schedule of activities
- Enrollment visit before the endoscopy (ALL PATIENTS), in the outpatient clinic, or before the EMR.
Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation before their scheduled procedure. 2. EMR intervention (ALL PATIENTS meeting eligibility criteria). Only if a polyp meets inclusion criteria, the study subject will be enrolled. The standard endoscopic mucosal resection (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 is 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 is facilitated using standard microprocessor-controlled electrocautery. If residual polyp tissue cannot remove by a snare, other means such as cold snare (i.e., for small residual polyp tissue that cannot be engaged into standard snares), hot avulsion technique or Argon plasma coagulation or soft coagulation by the tip of snare can be used.
The polyp site will be marked with submucosal injection of approximately 1-2cc of India ink (standard of care to mark lesions in the colon safely) to allow recognition at follow-up endoscopy. Polyps are sent to the pathology lab and evaluated according to standard practice by institutional pathologists.19 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Ethnicity and race
- •Patient referred for endoscopic resection of all colorectal polyps non-pedunculated equal or greater 20 mm
- •Written informed consent
排除标准
- •Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
- •Previous partial EMR
- •Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- •Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
- •Patients with inflammatory bowel disease
- •Patients who are receiving an emergency colonoscopy
- •Poor general health (ASA class>3)
- •Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
- •Poor bowel preparation (Boston bowel prep score ≤2)
- •Target sign or perforation during initial EMR
- •Need for ESD for complete resection prior to APC
- •Pregnancy and breast-feeding.
研究组 & 干预措施
Group treatment h-APC and EMR
Standard endoscopic mucosal resection (EMR) technique will be used for primary removal of all polyps. Submucosal injection will be used to lift the polyp from the muscularis propria. Injection is 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 is facilitated using standard microprocessor controlled electrocautery (e.g. ERBE VIO Endocut 3-1-6). Ablation of the margin after visibly complete removal of the polyp is routinely applied. For thermal ablation hybrid APC (Erbe Hybrid APC) will be applied using standard settings on the margin and resection base. Once resection and thermal ablation is considered complete the mucosal defect can be closed with clips or another preventative measure applied to reduce the risk for post-polypectomy bleeding.
干预措施: Hybrid Argon Plasma Coagulation and EMR procedure (Procedure)
结局指标
主要结局
Post-EMR recurrence at FU1
时间窗: 4 months (+- 2 months) after the index h-APC and EMR procedure
The post-EMR recurrence at FU1 is defined as the rate of first follow-up colonoscopies with found adenomas.
次要结局
- Complete adenoma eradication rates(Within 1 year after the index EMR)
- Incidence of complications(14 days after the index EMR)
- Severe bleeding complication rate(14 days after the index EMR)
- Perforation rate(14 days after the index EMR)
- Post-polypectomy syndrome incidence(14 days after the index EMR)
- Completeness of polyp resection(14 days after the index EMR)
- Intraprocedural bleeding rate(During the procedures)
- Need for colon resection rate(Within 1 year after the index EMR)
研究者
Daniel Von Renteln
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)