Back to resultsFull-spectrum Endoscopy in Colorectal Cancer Screening
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
colonoscopy procedure
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring full-spectrum endoscopy, polyp detection rate, colorectal cancer, colorectal screening, adenoma detection rate, endoscopic innovations
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
full-spectrum colonoscopy
standar forward-viewing colonoscopy
Arm Description
Colonoscopy is performed with a full-spectrum colonoscopy (330º angle of view)
Colonoscopy is performed with standar forward-viewing colonoscopy (170º angle of view)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
time to caecal intubation in each group
time to reach appendicular orifice
total procedure time in each group
time since the begining of the procedure till is totally finish
Adverse events
Any inmediatly complication
advance adenoma rate in each group
10mm or greater in size, villous component or high grade dysplasia
polyp detection rate in right and left colon in each group
polyp retrieval rate in each group
proportion of resected polyps that were retrieved and sent for histologically analysis
caecal intubation rate in each group
proportion of all colonoscopic procedures in which the caecum, terminal ileum was reached
colonoscopy withdrawal time
average time taken withdraw the colonoscope from the caecal pole to the anus.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02812550
Brief Title
Full-spectrum Endoscopy in Colorectal Cancer Screening
Official Title
Impact of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Río Hortega
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
full-spectrum endoscopy, polyp detection rate, colorectal cancer, colorectal screening, adenoma detection rate, endoscopic innovations
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
full-spectrum colonoscopy
Arm Type
Other
Arm Description
Colonoscopy is performed with a full-spectrum colonoscopy (330º angle of view)
Arm Title
standar forward-viewing colonoscopy
Arm Type
Other
Arm Description
Colonoscopy is performed with standar forward-viewing colonoscopy (170º angle of view)
Intervention Type
Procedure
Intervention Name(s)
colonoscopy procedure
Intervention Description
endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy
Primary Outcome Measure Information:
Title
adenoma detection rate in the two different colonoscopies
Description
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
time to caecal intubation in each group
Description
time to reach appendicular orifice
Time Frame
one week
Title
total procedure time in each group
Description
time since the begining of the procedure till is totally finish
Time Frame
one week
Title
Adverse events
Description
Any inmediatly complication
Time Frame
one week
Title
advance adenoma rate in each group
Description
10mm or greater in size, villous component or high grade dysplasia
Time Frame
one week
Title
polyp detection rate in right and left colon in each group
Time Frame
one week
Title
polyp retrieval rate in each group
Description
proportion of resected polyps that were retrieved and sent for histologically analysis
Time Frame
one week
Title
caecal intubation rate in each group
Description
proportion of all colonoscopic procedures in which the caecum, terminal ileum was reached
Time Frame
one week
Title
colonoscopy withdrawal time
Description
average time taken withdraw the colonoscope from the caecal pole to the anus.
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª Henar Núñez Rodriguez, MD, PhD
Organizational Affiliation
Hospital del Rio Hortega Valladolid, Spain
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29283904
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.
Results Reference
derived
Learn more about this trial
Full-spectrum Endoscopy in Colorectal Cancer Screening
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