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临床试验/NCT06596317
NCT06596317已完成不适用

Impact of Indigo Carmine Pump Spraying on the Adenoma Detection Rate: A Randomized Controlled Trial

Shandong University1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2024年1月11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
330
试验地点
1
主要终点
adenoma detection rate(ADR)

研究概览

简要总结

Detection and removal of polyps during colonoscopy is crucial for the prevention of colorectal cancer. Indigo carmine spraying up to the colonic mucosa could probably increase the adenoma detection rate. The traditional method of dye spraying with spraying catheter or syringe would consume a lot of time and dye volume. Now, the more convenient auxiliary water supply channel can be used to spray indigo carmine. In order to explore the clinical application value of spraying indigo carmine solution by auxiliary water channel in high-risk population, we performed a prospective, randomized controlled trial to compare adenoma detection rate of conventional colonoscopy and chromoendoscopy.

详细描述

If patients scheduled for colonoscopy meet the inclusion criteria but not the exclusion criteria, he or she will be recruited to the study and randomized to one of two groups. Subjects in Group A (treatment group) will undergo colonoscopy with spraying indigo carmine solution during withdrawal process. Subjects in Group B (control group) will undergo a standard conventional colonoscopy without spraying any solution during withdrawal process. The traditional method of dye spraying with spraying catheter or syringe would consume a lot of time and dye volume. The solution spraying process was implemented by a water jet channel using auxiliary foot pump. Any lesions found during the procedure will be removed and sent for pathological examination. The investigator will record the patient's general information (such as gender, age, symptoms, body mass index, etc.), colonoscopy data (such as duration, dye amount, etc.), and lesion characteristics (such as location, morphology, histopathological classification, etc.). Randomization was done with SPSS program. All data were analyzed according to the ITT analysis, and the PP analysis was performed for all outcomes. Continuous variables were presented as means ± standard deviation (SD), and compared using the Student t test. Categorical data were expressed as number with percentage and analyzed using the chi-squared test or the Fisher exact test. All statistical analyses were performed using IBM SPSS Statistics or R Statistics, and 2-sided P<0.05 was statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a history of colorectal cancer or colorectal adenoma
  • Patients whose first-degree relatives have a history of colorectal cancer or colorectal adenoma
  • Patients with gastrointestinal symptoms (abdominal pain, bloody stool, chronic diarrhea or constipation, Unexplained anemia or weight loss;
  • Patients with positive fecal occult blood tests

排除标准

  • Patients with severe comorbidity
  • Patients who are not suitable for colonoscopy
  • Patients who received urgent or therapeutic colonoscopy
  • Patients with pregnancy, inflammatory bowel disease, polyposis syndromes, suspected CRC; intestinal obstruction, coagulopathy
  • Patients with aspirin, clopidogrel or other anticoagulants/ antiplatelet drugs intake within 7 days
  • Patients with failed cecal intubation
  • Patients with inadequate bowel preparation quality (Boston score ≤5)
  • Patients who refuse to participate or to provide informed consent

结局指标

主要结局

adenoma detection rate(ADR)

时间窗: procedure time

ADR was calculated as the number of patients with at least one adenoma divided by the total number of patients. In other words, the adenoma detection rate of the sample was the proportion of patients with adenoma detected.

次要结局

  • detected rate of different lesions(procedure time)

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanqing Li

Director

Shandong University

研究点 (1)

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