Full-spectrum Endoscopy in Colorectal Cancer Screening

NCT ID: NCT02812550

Last Updated: 2016-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-06-30

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)

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

full-spectrum colonoscopy

Colonoscopy is performed with a full-spectrum colonoscopy (330º angle of view)

Group Type: OTHER

colonoscopy procedure

Intervention Type: PROCEDURE

endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy

standar forward-viewing colonoscopy

Colonoscopy is performed with standar forward-viewing colonoscopy (170º angle of view)

Group Type: OTHER

colonoscopy procedure

Intervention Type: PROCEDURE

endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy

Interventions

colonoscopy procedure

endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital del Rio Hortega

OTHER

Sponsor Role: lead

Responsible Party

Mª Henar Núñez Rodriguez

Dra Mª Henar Núñez Rodriguez

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mª Henar Núñez Rodriguez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Rio Hortega Valladolid, Spain

References

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.

Reference Type: DERIVED

PMID: 29283904 (View on PubMed)

Other Identifiers

GRS 1073/A/15

Identifier Type: -

Identifier Source: org_study_id