Clinical trial NCT02812550: Full-spectrum Endoscopy in Colorectal Cancer Screening
Official title: Impact of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: full-spectrum endoscopy
polyp detection rate
colorectal cancer
colorectal screening
adenoma detection rate
endoscopic innovations
Lead sponsor: Hospital del Rio Hortega
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 249
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to compare the adenoma detection rates of full-spectrum endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening programme.

Detailed description: Colorectal cancer is the third most common neoplasia and the second leading cause of cancer death in West countries. Colonoscopy is the gold standard for prevention of colorectal cancer disease. Screening for colorectal cancer with biennial faecal occult blood testing is a widely used strategy followed by colonoscopy for those with a positive test. Colonoscopy identifies polyps during the procedure as well as polyp removal in order to prevent progression to cancer. Although, interval cancer appears after a colonoscopy because of 22-28% of polyp missed rates. Advanced Technology may improve adenoma detection rates so decrease interval cancer and reduce mortally. Full-spectrum endoscopy with 330º angle vision decrease adenoma miss rate in general population.

The investigators conducted a randomized trial in patients from colorectal cancer screening programme (aged 50-69 years) after faecal immunological test positive. One arm the colonoscopy is performed with standard forward view colonoscopy (170º angle view) and the other arm is performed with full-spectrum endoscopy (EndoChoice) (330º angle view)

Eligibility criteria: Inclusion Criteria:

* patient referred for colorectal cancer screening with positive fecal inmunological test.
* Age between 50 and 69 years

Exclusion Criteria:

* history of colonic resection,
* high risk for colorectal cancer like family history of colorectal cancer o polyposis syndrome,
* inflammatory bowel disease,
* patients with lower gastrointestinal bleeding symptoms,
* acute diverticulitis,
* colonic strictures,
* poor bowel preparation (Boston scale less than 5 points)

Primary outcomes:
measure: adenoma detection rate in the two different colonoscopies
timeFrame: one week
Secondary outcomes:
measure: time to caecal intubation in each group
timeFrame: one week
measure: total procedure time in each group
timeFrame: one week
measure: Adverse events
timeFrame: one week
measure: advance adenoma rate in each group
timeFrame: one week
measure: polyp detection rate in right and left colon in each group
timeFrame: one week
measure: polyp retrieval rate in each group
timeFrame: one week
measure: caecal intubation rate in each group
timeFrame: one week
measure: colonoscopy withdrawal time
timeFrame: one week
Other outcomes:
Locations:
Study officials:
affiliation: Hospital del Rio Hortega Valladolid, Spain
name: Mª Henar Núñez Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nunez-Rodriguez H, Diez-Redondo P, Perez-Miranda M, Gonzalez Sagrado M, Conde R, De la Serna C. Role of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Trial. J Clin Gastroenterol. 2019 Mar;53(3):191-196. doi: 10.1097/MCG.0000000000000975.