High Definition Colonoscopy (HDC) vs. Dye Spraying Chromo-colonoscopy (DSC) in Screening Patients With Long-standing Inflammatory Bowel Disease (IBD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Detection rate of dysplastic lesions in High Definition White Light Colonoscopy versus Dye Spraying Chromo-colonoscopy
研究概览
简要总结
Inflammatory Bowel Disease (IBD) involving the colon is a known risk for colon cancer. There are two standards-of-care colonoscopy techniques used for screening all patients who suffer from IBD for more than eight years. One method is to obtain random biopsies throughout the colon and the other is by using dye spraying chromo-colonoscopy.
This trial aims to study the difference between the two colonoscopy techniques during the era of high definition camera in detecting neoplastic lesions during screening patients with long-standing IBD.
详细描述
Research Question:
Is High Definition White Light Colonoscopy (HDWLC) not inferior to Dye Spraying Chromo-colonoscopy (DSC) in detecting all neoplastic lesions during screening patients with colonic IBD for more than eight years?
Study setting: The study will be conducted at Beth Israel Deaconess Medical Center. Patients will be randomized to HDWLC with biopsies every 10 cm versus DSC.
Study population: Adult patients colonic IBD for more than eight years.
Recruitment The study team will conduct a day by day chart review for all patients with a history of inflammatory bowel disease who were scheduled for screening colonoscopy and find candidates who meet the eligibility criteria. A study team member will meet with the potential candidates during their visit to the gastroenterology procedure room before having their colonoscopy and offer them to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
In this study, we will randomize a total of 500 participants into two arms: A. high definition white light colonoscopy with biopsy (n=250) or B. chromocolonoscopy (n=250).
The randomization schedule was created by using GraphPad website. Then sealed opaque envelopes which numbered from 1 to 500 for all subjects were created based on the randomization schedules by one of the study co-investigators (Mohammed El-Dallal MD). These envelopes will be opened only by the endoscopy provider once the subject agrees and sings the informed consent. Of note, the randomization schedules will be saved in a separate document that only Mohammed El-Dallal MD has access to it. Neither the participants nor the study members (other than Mohammed El-Dallal MD) know about the assignment before opening the envelopes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥18yr old
- •History of UC or colonic Crohn's disease or unclassified colitis patients with or without colonic adenoma history
- •Duration of ≥ eight years since diagnosis, or any duration with a diagnosis of primary sclerosing cholangitis
- •Mucosal lesion involves ≥ 1/3 of the colon
排除标准
- •History of colorectal cancer
- •History of total colectomy
- •Prior colonoscopy within the last 6 months
- •Allergy to dye spray
- •Poor bowel preparation
- •Unable to provide informed consent
- •Severe inflammation preventing visualization of the mucosa during the procedure.
研究组 & 干预措施
High Definition White Light Colonoscopy
干预措施: High Definition Colonoscopy (Device)
Dye Spraying Chromo-colonoscopy
干预措施: Dye Spraying Chromocolonoscopy (Device)
结局指标
主要结局
Detection rate of dysplastic lesions in High Definition White Light Colonoscopy versus Dye Spraying Chromo-colonoscopy
时间窗: Immediately after the procedure
次要结局
- Numbers of detected adenomas per patient.(Immediately after the procedure)
- Appropriateness of reported follow up recommendations per standard guideline recommendations(Immediately after the procedure)
- Detection rate of high-grade dysplasia in both groups.(Immediately after the procedure)
- Difference in adverse event, mild (e.g.; nausea, vomiting, or abdominal pain that necessitate phone call from the patient to the provider, or sever (e.g.; GI bleeding, perforation, hospitalization after the procedure) for each arm.(Within one week from the procedure date)
- Number of targeted chromoendoscopies(Immediately after the procedure)
- Detection rate of Adenoma in both groups.(Immediately after the procedure)
- Difference in withdrawal time to perform the procedure in both groups.(Immediately after the procedure)
研究者
Joseph Feuerstein
Assistant Professor of Medicine
Beth Israel Deaconess Medical Center