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

NCT ID: NCT02581475

Last Updated: 2016-10-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Colonic Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Extending withdrawal time in the proximal colon: After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.

From cecum to hepatic flexure, 1.5-2 min is required and 2.5-3 min is required from heptic flexure to splenic flexure.

Group Type ACTIVE_COMPARATOR

Extending withdrawal time in the proximal colon

Intervention Type PROCEDURE

Group B

Segmental examination twice of the proximal colon: After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure. The withdrawal time in each colonic segment is similar to the group A.

Group Type EXPERIMENTAL

Segmental examination twice of the proximal colon

Intervention Type PROCEDURE

Interventions

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Extending withdrawal time in the proximal colon

Intervention Type PROCEDURE

Segmental examination twice of the proximal colon

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yanqing Li

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD, MD

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

References

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Martinez 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.

Reference Type BACKGROUND
PMID: 19171141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24394752 (View on PubMed)

Heresbach D, Barrioz T, Lapalus MG, Coumaros D, Bauret P, Potier P, Sautereau D, Boustiere C, Grimaud JC, Barthelemy C, See 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.

Reference Type BACKGROUND
PMID: 18389446 (View on PubMed)

Guo CG, Zhang F, Ji R, Li Y, Li L, Zuo XL, Li YQ. Efficacy of segmental re-examination of proximal colon for adenoma detection during colonoscopy: a randomized controlled trial. Endoscopy. 2017 Mar;49(3):243-250. doi: 10.1055/s-0042-122013. Epub 2017 Jan 27.

Reference Type DERIVED
PMID: 28129661 (View on PubMed)

Other Identifiers

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2015SDU-QILU-G12

Identifier Type: -

Identifier Source: org_study_id

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