Full-spectrum Endoscopy in Colorectal Cancer Screening

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: colonoscopy procedure

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)

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: full-spectrum colonoscopy; Colonoscopy is performed with a full-spectrum colonoscopy (330º angle of view)	Procedure: colonoscopy procedure; endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy
Other: standar forward-viewing colonoscopy; Colonoscopy is performed with standar forward-viewing colonoscopy (170º angle of view)	Procedure: colonoscopy procedure; endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to caecal intubation in each group	time to reach appendicular orifice	one week
total procedure time in each group	time since the begining of the procedure till is totally finish	one week
Adverse events	Any inmediatly complication	one week
advance adenoma rate in each group	10mm or greater in size, villous component or high grade dysplasia	one week
polyp detection rate in right and left colon in each group		one week
polyp retrieval rate in each group	proportion of resected polyps that were retrieved and sent for histologically analysis	one week
caecal intubation rate in each group	proportion of all colonoscopic procedures in which the caecum, terminal ileum was reached	one week
colonoscopy withdrawal time	average time taken withdraw the colonoscope from the caecal pole to the anus.	one week

Collaborators and Investigators

• Sponsor: Hospital del Río Hortega
• Investigators: Principal Investigator: Mª Henar Núñez Rodriguez, MD, PhD, Hospital del Rio Hortega Valladolid, Spain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Estimate): June 24, 2016
• Last Update Submitted That Met QC Criteria: June 21, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: colorectal cancer; adenoma detection rate; polyp detection rate; full-spectrum endoscopy; colorectal screening; endoscopic innovations
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: GRS 1073/A/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO