Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 928
- 试验地点
- 1
- 主要终点
- Number of Participants With Delayed Bleeding Complications
研究概览
简要总结
The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.
详细描述
Aim 1. The primary aim of the study is to compare the rate of delayed bleeding complications in patients undergoing endoscopic resection of large polyps between:
- A) Closing the mucosal defect after resection (Clip group) and
- B) Not closing the mucosal defect after resection (No clip group).
Aim 2. The secondary aim of the study is to compare the rate of overall complications in patients undergoing endoscopic resection of large polyps between two cautery settings:
- A) Low power coagulation and
- B) Endocut.
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
- 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
- •Any patient ≥18 and ≤89 who presents for a colonoscopy and who does not have criteria for exclusion
- •Patients with a ≥20mm non-pedunculated colon polyp
排除标准
- •Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
- •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
- •Pregnancy
研究组 & 干预措施
No clip closure + Coagulation
No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.
Clip closure + EndoCut
Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.
干预措施: Clip closure (Procedure)
Clip closure + Coagulation
Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.
干预措施: Clip closure (Procedure)
No clip closure + EndoCut
No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.
结局指标
主要结局
Number of Participants With Delayed Bleeding Complications
时间窗: 30 days following a study polyp resection
A bleeding event that occurred within 30 days after completion of the colonoscopy with a study polyp resection and is associated with a decrease in hemoglobin by at least 2gm, hemodynamic instability, presentation to the ED, need for hospitalization, repeat colonoscopy, or other interventions.
次要结局
- Polyp Recurrence Rate(3 months to 5 years)
- The Overall Number of Complications(30 days)
- Complete Study Polyp Resection Rate(6 months)
- The Number of Complications Associated With Clip Use(30 days)
研究者
Dr. Heiko Pohl
Principal Investigator
White River Junction Veterans Affairs Medical Center