High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps

Colonic Adenoma Clinical Trial

Official title:

High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243669
• Other study ID #: S52580
• Status: Completed
• Phase: N/A
• Start date: December 1, 2010
• Est. completion date: December 31, 2014

Study information

• Verified date: August 2017
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2146
• Est. completion date: December 31, 2014
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• referred for colonoscopy
• signed informed consent

Exclusion Criteria:

• subtotal colectomy
• known colorectal tumor or polyp prior to colonoscopy
• genetic predisposition to colon cancer namely FAP, HNPCC, Hyperplastic polyposis syndrome, juvenile polyposis, Peutz-Jeghers syndrome
• inflammatory bowel disease
• primary sclerosering cholangitis

Related Conditions & MeSH terms

• Adenoma
• Colonic Adenoma

Intervention

Diagnostic Test:
• High-definition
High-definition colonoscopy
• Virtual chromoendoscopy
Virtual chromoendoscopy
• Standard
Standard colonoscopy

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2017 Apr;49(4):378-397. doi: 10.1055/s-0043-103411. Epub 2017 Mar 7. — View Citation

Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015 Jan;110(1):72-90. doi: 10.1038/ajg.2014.385. Epub 2014 Dec 2. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate (ADR)	Percentage of colonoscopies with detection of 1 or more adenomas. ADR is a well-established quality indicator in colonoscopy in the prevalence of adenomas detected (ADR) as recommended by American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Task Force (ACGTF) and European Society of Gastrointestinal Endoscopy (ESGE). Guidelines stipulate to use ADR as main quality indicator in colonoscopy.	7-10 days
Secondary	Number of adenomas	Adenoma per colonoscopy rate (APCR)	7-10 days
Secondary	Type of adenomas	Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas	7-10 days