Effectiveness and Safety of the Colonoscopy Assisted by Endocuff vs. Standard in the Colorectal Cancer Screening

Hospital Provincial de Castellon

Status

Completed

Conditions

Cancer Colorectal

Treatments

Device: Colonoscopy procedure with endocuff

Study type

Interventional

Funder types

Other

Identifiers

NCT04280393

FCVHPC-2018-PS-01

Details and patient eligibility

About

The hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases the detection rate of adenomas thanks to the improved visibility produced by the retraction of the folds and stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF VISION® on the average number of adenomas detected per patient (MAPP) as well as serrated adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety of its use will be estimated.

Full description

The main objective of the colorectal cancer screening program (CRC) is the detection of the greatest number of precursor lesions of neoplasms as well as cancerous lesions established in the general population with an intermediate risk of presenting CRC. Within this program, colonoscopy is considered the diagnostic technique of choice due to its cost-effectiveness balance. However, it remains a technique that is not entirely perfect since the omission of injuries during the procedure constitutes the main reason for the appearance of interval cancers, with a clear correlation between the rate of detection of adenomas and their appearance.

The vast majority of CRC arise from precancerous polyps, of which there are two main types: conventional adenomas and serrated polyps. Conventional adenomas are the most frequent polyps being responsible for the majority of CRC through the adenoma-carcinoma sequence. It should be taken into account that about 15-30% of sporadic CRC develops from serrated polyps through the serrated pathway of carcinogenesis, which is different from the traditional adenoma-carcinoma sequence. Endoscopic detection of serrated polyps is difficult due to their indistinguishable edges and flat or sessile morphology. In addition, they tend to be located in the right colon, a place that can be more difficult to reach in colonoscopy and examine completely.

Therefore, the ultimate goal of CRC screening colonoscopy is to reduce the appearance of CRC, trying to maximize the detection of polyps and therefore the detection rate of adenomas. For this there are several technical factors of colonoscopy, preparation, imaging and external devices that try to achieve an increase in the rate of detection of adenomas.

ENDOCUFF VISION® (Norgine Pharmaceuticals Ltd) is a medical device that is fixed at the distal end of the endoscope, improving its insertion in the intestine thanks to the action it exerts by flattening the folds and stabilizing the device. Its use is related to greater accuracy in the detection of adenomas, since it increases the visibility of the mucosa and thus decreases the number of polyps that may go unnoticed, increasing the detection rate of adenomas between 10 and 16 percentage points, according with published literature .

Thus, the hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases the detection rate of adenomas thanks to the improved visibility produced by the retraction of the folds and stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF VISION® on the average number of adenomas detected per patient (MAPP) as well as serrated adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety of its use will be estimated.

Enrollment

822 patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A) Patients between the ages of 50 and 70 referred for a colonoscopy within the colorectal cancer screening program.

B) With the ability to provide informed consent

Exclusion criteria

History of inflammatory bowel disease
History or suspected obstruction or intestinal pseudo-obstruction located in the colon
History of colon cancer or polyposic syndromes
History of colonic stenosis
History of severe diverticular segments in some region of the colon
Subjects unable to provide informed consent
Subjects under treatment with clopidogrel, warfarin, acenocoumarol or other new generation anticoagulants that have not discontinued treatment in accordance with the provisions of these procedures
Pregnants females
Subjects who are going to undergo a therapeutic or surveillance endoscopy for follow-up of injuries diagnosed in previous procedures
Subjects whose baseline status does not allow the completion of the questionnaires necessary for the evaluation of the study objectives.
History of previous colonic surgery except for appendectomy
Any medical, psychological, psychiatric, geographic or social problem that is important and uncontrolled that may interfere with the patient's participation in the study or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.