Full-spectrum Endoscopy in Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

Official title:

Impact of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812550
• Other study ID #: GRS 1073/A/15
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: June 21, 2016
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Hospital del Río Hortega
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 69 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• colonoscopy procedure
endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Río Hortega

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adenoma detection rate in the two different colonoscopies	number of colonoscopies at wich one or more histologically confirmed adenomas were found divided by the total number of colonoscopies performed in the same time period.	one week	No
Secondary	time to caecal intubation in each group	time to reach appendicular orifice	one week	No
Secondary	total procedure time in each group	time since the begining of the procedure till is totally finish	one week	No
Secondary	Adverse events	Any inmediatly complication	one week	No
Secondary	advance adenoma rate in each group	10mm or greater in size, villous component or high grade dysplasia	one week	Yes
Secondary	polyp detection rate in right and left colon in each group		one week	Yes
Secondary	polyp retrieval rate in each group	proportion of resected polyps that were retrieved and sent for histologically analysis	one week	Yes
Secondary	caecal intubation rate in each group	proportion of all colonoscopic procedures in which the caecum, terminal ileum was reached	one week	Yes
Secondary	colonoscopy withdrawal time	average time taken withdraw the colonoscope from the caecal pole to the anus.	one week	Yes