Efficacy of Segmental Examination Twice of the Proximal Colon on Adenoma Detection

Colonic Polyps Clinical Trial

Official title:

Efficacy of Segmental Examination Twice of Proximal Colon on Adenoma Detection: a Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02581475
• Other study ID #: 2015SDU-QILU-G12
• Status: Recruiting
• Phase: N/A
• First received: October 19, 2015
• Last updated: April 11, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: April 2016
• Source: Shandong University
• Contact: Yanqing Li, PhD, MD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

Segmental examination twice of the proximal colon might be helpful to increase adenoma detection rate (ADR).

Description:

Colonoscopy is the gold standard screening test for colorectal cancer (CRC). Removal of adenomas can reduce the incidence and mortality of CRC. However, there is evidence that some patients may develop interval cancers—cancers developed within 3-5 years following colonoscopy and polypectomy. The overall rate of interval cancer was 1.1-2.7 per 1000 person-years. Several studies have suggested that patients who develop interval cancers are more likely to have proximal compared than distal cancers.

One hypothesis is that adenomas may be more likely to be missed in the proximal colon compared with the distal colon. Serrated polyps and some adenomas in the proximal colon may be difficult to detect if they are flat, covered with mucus, or behind folds. A second hypothesis is that neoplastic lesions of the proximal colon may biologically differ from distal lesions and progress to malignancy with a short dwell time.

Several tandem back to back colonoscopy studies have demonstrated that up to 27% adenomas in the proximal colon are missed during routine screening colonoscopy. Hover, examining the colon twice as that in the back to back studies is difficult to be performed in clinical practice. Thus, we developed a novel colonoscopy technique, segmental examination twice of the proximal colon, that is simple and easy to be performed. The current study aims to examine the efficacy of segmental examination twice of the proximal colon on adenoma detection rate (ADR) during routine screening and surveillance colonoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Asia-Pacific Colorectal Screening score =2, such as patients = 50 years, patients with a family history of colorectal cancer in a first-degree relative or male patients with current or past smoking.

Exclusion Criteria:

• Patients with prior resection of the proximal colon, advanced colonic cancer, inflammatory bowel disease, or polyposis syndrome.

• The cecum could not be intubated.

• Inadequate bowel preparation (Boston Bowel Preparation Scale score <2 in any segment of the colon).

• Biopsies were not available.

• Unable to provide informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colonic Polyps

Intervention

Procedure:
• Extending withdrawal time in the proximal colon

• Segmental examination twice of the proximal colon

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yanqing Li

Country where clinical trial is conducted

China, 

References & Publications (3)

Butterly L, Robinson CM, Anderson JC, Weiss JE, Goodrich M, Onega TL, Amos CI, Beach ML. Serrated and adenomatous polyp detection increases with longer withdrawal time: results from the New Hampshire Colonoscopy Registry. Am J Gastroenterol. 2014 Mar;109(3):417-26. doi: 10.1038/ajg.2013.442. Epub 2014 Jan 7. — View Citation

Heresbach D, Barrioz T, Lapalus MG, Coumaros D, Bauret P, Potier P, Sautereau D, Boustière C, Grimaud JC, Barthélémy C, Sée J, Serraj I, D'Halluin PN, Branger B, Ponchon T. Miss rate for colorectal neoplastic polyps: a prospective multicenter study of back-to-back video colonoscopies. Endoscopy. 2008 Apr;40(4):284-90. doi: 10.1055/s-2007-995618. — View Citation

Martínez ME, Baron JA, Lieberman DA, Schatzkin A, Lanza E, Winawer SJ, Zauber AG, Jiang R, Ahnen DJ, Bond JH, Church TR, Robertson DJ, Smith-Warner SA, Jacobs ET, Alberts DS, Greenberg ER. A pooled analysis of advanced colorectal neoplasia diagnoses after colonoscopic polypectomy. Gastroenterology. 2009 Mar;136(3):832-41. doi: 10.1053/j.gastro.2008.12.007. Epub 2008 Dec 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of adenoma detection rate in the proximal colon among 2 group.		12 months	No
Secondary	Withdrawal time in the proximal colon among 2 group.		12 months	No
Secondary	Duration of the total colonoscopy among 2 group.		12 months	No
Secondary	Adenomas per patient in the proximal colon among 2 group.		12 months	No