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临床试验/NCT06097650
NCT06097650已完成不适用

Cold Snare Polypectomy Versus Hot Snare Polypectomy for the Resection of Small Pedunculated Colorectal Polyps: a Multicentre Randomised Controlled Trial

Ningbo No. 1 Hospital1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2023年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
196
试验地点
1
主要终点
delayed hemorrhage

研究概览

简要总结

Endoscopic resection of pedunculated polyps mainly focuses on how to prevent bleeding, and also needs to pay attention to the convenience of resection and the integrity of resection, which means that different endoscopic resection strategies should be adopted for pedunculated polyps with different stalk sizes. Small pedunculated polyps with heads smaller than 20mm and stalks less than or equal to 5mm are defined as having a relatively small risk of bleeding. Preliminary studies in recent years suggest that the use of cold snare polypectomy for small pedunculated polyps may also be a safe resection strategy. However, for small pedunculated polyps, ASGE and ESGE guidelines currently recommend hot snare polypectomy in the middle and lower pedicles (evidence level medium). Therefore, the provision of high-quality clinical evidence related to cold resection techniques in the resection strategy of small pedunculated polyps may provide a basis for revision of guidelines.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Patients undergoing endoscopic resection of small pedicled polyps in the First Affiliated Hospital of Ningbo University, The Third People's Hospital Health Care Group of Cixi, Ninghai Second Hospital and Renmin Hospital of Yuyao City from October 2023 to August 2026;
  • Patients who voluntarily agreed to participate in this study and signed informed consent.

排除标准

  • 1. Persons under 18 years of age
  • Persons unwilling or unable to provide informed consent
  • Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months 4.polyps with endoscopic features suspicious for carcinoma
  • Abdominal symptoms such as severe abdominal pain, abdominal distension, and nausea 6.Patients with inadequate intestinal preparation
  • Patients with lifelong anticoagulant therapy or severe bleeding diseases, patients who have recently taken anticoagulant drugs or antiplatelet drugs (within 1 week) 8.Pregnant or lactating

结局指标

主要结局

delayed hemorrhage

时间窗: 2 days, 2 weeks and 4 weeks

Any symptoms of gastrointestinal bleeding (e. g. hematochezia) occurred within 30 days after polypectomy and were classified as mild or severe according on the severity of the bleeding

次要结局

  • Prevalence of immediate bleeding(1 Minutes)

研究者

发起方
Ningbo No. 1 Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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