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

Primary Purpose

Colonic Polyps

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Extending withdrawal time in the proximal colon
Segmental examination twice of the proximal colon
Sponsored by
Yanqing Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonic Polyps focused on measuring Adenoma detection rate, Colonoscopy, Withdrawal time

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Gastroenterology, Qilu Hospital, Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

Extending withdrawal time in the proximal colon: After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.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

Segmental examination twice of the proximal colon: After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again.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.

Outcomes

Primary Outcome Measures

Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group.
Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.

Secondary Outcome Measures

Withdrawal Time in the Proximal Colon Among 2 Group.
Duration of the Total Colonoscopy Among 2 Group.
Adenomas Per Patient in the Proximal Colon Among 2 Group.

Full Information

First Posted
October 19, 2015
Last Updated
August 26, 2016
Sponsor
Yanqing Li
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1. Study Identification

Unique Protocol Identification Number
NCT02581475
Brief Title
Efficacy of Segmental Examination Twice of the Proximal Colon on Adenoma Detection
Official Title
Efficacy of Segmental Examination Twice of Proximal Colon on Adenoma Detection: a Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanqing Li

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
Keywords
Adenoma detection rate, Colonoscopy, Withdrawal time

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
386 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Extending withdrawal time in the proximal colon
Intervention Type
Procedure
Intervention Name(s)
Segmental examination twice of the proximal colon
Primary Outcome Measure Information:
Title
Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group.
Description
Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.
Time Frame
During routine screening and surveillance colonoscopy, for up to 1 hour, number of adenomas was recorded. About 1 month after this study, adenoma detetion rates were calculated.
Secondary Outcome Measure Information:
Title
Withdrawal Time in the Proximal Colon Among 2 Group.
Time Frame
During routine screening and surveillance colonoscopy, for up to 1 hour, withdrawal time was recorded. About 1 month after this study, mean withdrawal time was calculated.
Title
Duration of the Total Colonoscopy Among 2 Group.
Time Frame
During routine screening and surveillance colonoscopy, for up to 1 hour, the duration of colonoscopy was recorded. About 1 month after this study, mean duration of the colonoscopy was calculated.
Title
Adenomas Per Patient in the Proximal Colon Among 2 Group.
Time Frame
During routine screening and surveillance colonoscopy, for up toafter 1 hour, the number of adenomas was recorded. About 1 month after this study, mean number of adenomas in proximal colon was calculated.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PhD, MD
Organizational Affiliation
Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19171141
Citation
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.
Results Reference
background
PubMed Identifier
24394752
Citation
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.
Results Reference
background
PubMed Identifier
18389446
Citation
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.
Results Reference
background
PubMed Identifier
28129661
Citation
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.
Results Reference
derived

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

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