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临床试验/NCT06220149
NCT06220149招募中不适用

FIT for Post poLypectomy bLeeding Prediction

Carol Davila University of Medicine and Pharmacy1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Day of maximum probability of positive FIT to detect delayed post polypectomy bleeding

研究概览

简要总结

Patients with colorectal polyps removed endoscopically (polypectomy, endoscopic mucosal resection, underwater endoscopic mucosal resection, endoscopic submucosal dissection) may experience delayed post polypectomy bleeding. The incidence is about one in 40 cases.

There are risks factors for this complication, depending on the polyp type, patient demographics and co-morbidities and polypectomy technique. There are meta-analysis and nomograms for risk prediction available.

We will try to predict delayed post polypectomy bleeding by using FIT (fecal immunochemical test), with a cut-off adapted to detect post polypectomy bleeding, administered daily for 2 weeks after polypectomy.

详细描述

Why should one be concerned about delayed post polypectomy bleeding (DPPB)? One in 40 patients with polypectomy for large polyps will have it. A large systematic review of 50 studies including 6779 large polyps > 20mm resected by polypectomy, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), "en bloc" or in piece-meal have had an DPPB incidence of 2.6% (2.1% - 3.2%) [1].

Cand we generally predict what group of patients are more likely to have DPPB? Jaruvongvanich et al [2] have designed a meta-analysis of 12 studies on 14,313 patients. The pooled DPPB rate was 1.5% (0.7% - 3.4%). Cardiovascular disease (OR = 1.55), hypertension (OR = 1.53), polyp size > 10 mm (OR = 3.41), and polyps located in the right colon (OR = 1.60) were identified as significant DPPB risk factors, whereas age, sex, alcohol use, smoking, diabetes, cerebrovascular disease, pedunculated morphology, and carcinoma histology were not.

Huai et al [3] have designed a nomogram for DPPB prediction, based on 6 parameters, with a high AUC of 0.824 in the validation model, as in Figure 1, below. The model states that older men on anticoagulant, with pedunculated polyps on the right side are likely to bleed more often. Age, gender, and pedunculated morphology were included in the model, as risk factors, as opposed to previously mentioned paper [2]. The jury is probably still out for certain risk factors.

Yet, at the individual level, what could a patient do? Could a form of active surveillance for DPPB may be proposed?

Here's an idea. Fecal Immunochemical Test (FIT). FIT can detect minute quantities of hemoglobin in faces. It is used for colorectal cancer population screening in asymptomatic average risk individuals (eg. 50 to 75 years old) or in primary care in certain groups of symptomatic individuals, without overt rectal bleeding, as an adjunct decision tool for colonoscopy evaluation [5]. A recent meta-analysis on more than 6 million asymptomatic average risk individuals of which more than 2.6 million completed a screening FIT test have found a 5.4% positivity rate, an 85% colonoscopy completion rate, a 47.8% adenoma detection rate, a 25.3% advanced adenoma detection rate and a 5.1% colorectal cancer rate [6].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patient with at least one advanced adenoma > 10mm diameter resected at colonoscopy by polypectomy, EMR, underwater EMR or ESD
  • Age > 18 years old
  • Written informed consent.

排除标准

  • Synchronous advanced colorectal cancer
  • Synchronous unresected advanced adenomas
  • Concomitant inflammatory bowel disease or any active colitis
  • Absence of written informed consent

结局指标

主要结局

Day of maximum probability of positive FIT to detect delayed post polypectomy bleeding

时间窗: 14 days

Day (1 - 14) of positive FIT with maximum 24h before delayed post polypectomy bleeding

次要结局

  • Time of FIT positivity after polypectomy with no delayed post polypectomy bleeding(14 days)
  • Time to delayed post polypectomy bleeding(14 days)

研究者

发起方
Carol Davila University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mihai Ciocirlan

Associate Professor of Gastroenterology

Carol Davila University of Medicine and Pharmacy

研究点 (1)

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