Clinical trial NCT03839277: Adenoma Detection Rate Using Endocuff Vision in China
Official title: Adenoma Detection Rate Using Endocuff Vision in China
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Colorectal Neoplasms
Colonic Polyp
Adenoma
Keywords: adenoma detection rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Shanghai Zhongshan Hospital
name: Tianjin People's Hospital
name: Tianjin Nankai Hospital
First posted: 2019-02-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim of this study is

- to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR).

Other aims include to explore the data below when Endocuff Vision is used.

Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT

Detailed description: Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 5 centres, recruiting a total of 1200 participants.

Eligibility criteria: Inclusion Criteria:

* All patients referred for screening, surveillance, or diagnostic colonoscopy
* All patients must be able to give informed consent

Exclusion Criteria:

* Patients with any absolute contraindications to colonoscopy
* Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
* Patients with known colon cancer or polyposis syndromes
* Patients with known colonic strictures
* Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
* Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
* Patients lacking capacity to give informed consent
* Pregnancy
* Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
* Patients who are attending for a therapeutic procedure or assessment of a known lesion

Primary outcomes:
measure: Adenoma detection rate, ADR
timeFrame: At the end of the procedure, up to 1 hour.
Secondary outcomes:
measure: Polyp detection rate, PDR
timeFrame: At the end of the procedure, up to 1 hour.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
Study officials:
affiliation: Changhai Hospital
name: En-Da YU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.