BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma

赞助:

合作者:

信息的提供 (责任方):

LEUNG Wai Keung，The University of Hong Kong

追踪信息

首次提交日期 ^ICMJE

September 27, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

October 4, 2018

预计主要完成日期

September 30, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Proximal adenoma detection rate[ Time Frame: one day ]

proportion of patients with proximal adenoma detected

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

proximal polyp detection rate[ Time Frame: one day ]
proportion of patients with proximal polyp detected
proximal adenoma miss rate[ Time Frame: one day ]
proportion of patients with proximal adenoma detected
proximal polyp miss rate[ Time Frame: one day ]
proportion of patients with proximal polyp detected

描述性信息

简略标题 ^ICMJE

BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma

正式标题 ^ICMJE

Blue Laser Imaging Versus Narrow Band Imaging Versus White Light Imaging for Detection of Adenoma in the Proximal Colon: A Prospective, Randomized, Crossover Study

简要概况

This is a prospective randomized crossover trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (BLI), narrow band imaging or white light colonoscopy.

详细说明

Study population: Consecutive adult patients, age 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital are invited to participate in this prospective randomized study. Patients are excluded if they are unable to provide informed consent or have undergone previous colorectal resection, or have personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes. Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses were excluded. In addition, patients are excluded post-randomization if either the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is <2. Study design and randomization: This is a prospective randomized crossover trial comparing the proximal adenoma detection rate and miss rate of BLI (LASEREO endoscopic system) vs NBI (EXERA 290 video system) vs WLI (Fig.1) which is conducted in the Endoscopy Center of the Queen Mary Hospital of Hong Kong. Eligible patients are randomly allocated to four groups in a 1:1:1:1 ratio to undergo tandem colonoscopy of the proximal colon, defined as cecum to splenic flexure. The four groups are: (1) NBI (290) follow by WLI; (2) WLI follow up NBI (290); (3) BLI (LASEREO) follow by WLI; (4) WLI follow by BLI (LASEREO) in blocks of 8 (Figure 1). Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance). All procedures are performed with high-definition endoscopes and the LASEREO endoscopic system (Fujifilm Co, Tokyo, Japan) for BLI or the EVIS- EXERA 290 video system for NBI (Olympus Optical, Tokyo, Japan). The patients are blinded to the group assignment.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Crossover Assignment
干预模型描述: Prospective randomized cross-over design
盲法: Interventional
盲法描述:
主要目的: Diagnostic

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: Tandem colonoscopy
Tandem colonoscopy with different image modalities

研究工具

Experimental: NBI_WL
Tandem colonoscopy with NBI follow by WL
Active Comparator: WLI_NBI
Tandem colonoscopy with WLI follow by NBI
Experimental: BLI_WL
Tandem colonoscopy with BLI follow by WL
Active Comparator: WL_BLI
Tandem colonoscopy with WL follow by BLI

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

1200

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 31, 2020

预计主要完成日期

September 30, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Age 40 or above - scheduled for colonoscopy Exclusion Criteria: - unable to provide informed consent - have undergone previous colorectal resection, - personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes. - Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses - poor bowel preparation

性别

参与研究的性别:

All

年龄

最小年龄：40 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Hong Kong

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

LEUNG Wai Keung，The University of Hong Kong

研究赞助商 ^ICMJE

The University of Hong Kong

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Wai Keung Leung, MD The University of Hong Kong

PRS 账户

The University of Hong Kong

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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