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出境医 / 临床实验 / Three Arm Rand Trial of HD Light vs Reveal® Cap vs Endocuff Cap for Detection of Colorectal Adenomas (TRACE) (TRACE)

Three Arm Rand Trial of HD Light vs Reveal® Cap vs Endocuff Cap for Detection of Colorectal Adenomas (TRACE) (TRACE)

Study Description
Brief Summary:

Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas

Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone

Design: Multicenter, Prospective, randomized controlled study

Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.


Condition or disease Intervention/treatment Phase
Colorectal Adenoma Procedure: Colonoscopy Device: distal Cap Device: Endocuff Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three Arm Randomized Control Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Randomization will be done by computer allocation
Primary Purpose: Diagnostic
Official Title: Three Arm Prospective Randomized Controlled Trial of HD White-light Colonoscopy vs HD White-light Colonoscopy With Reveal® Distal Attachment Cap Versus HD White-light Colonoscopy With Endocuff Vision for the Detection of Colorectal Adenomas
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : June 10, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: High-Definition White-light Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps
Procedure: Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps

Active Comparator: High-Definition White-light Colonoscopy With Reveal®
Using an instrument called cap at end of colonoscope which is used to straighten colon folds
Procedure: Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps

Device: distal Cap
Using an instrument called cap at end of colonoscope which is used to straighten colon folds

Active Comparator: High-Definition White-light Colonoscopy With Endocuff Vision
Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
Procedure: Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps

Device: Endocuff
Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds

Outcome Measures
Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: Through the study (1 year) ]
    To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.


Secondary Outcome Measures :
  1. Number of Adenomas per person [ Time Frame: Through the study (1 year) ]
    To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

  2. detection rates of advanced adenomas [ Time Frame: Through the study (1 year) ]
    To compare the detection rates for advanced adenomas of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

  3. detect rates of serrated polyps [ Time Frame: Through the study (1 year) ]
    To compare the detection rates for serrated polyps of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

  4. detect rates of right sided adenomas [ Time Frame: Through the study (1 year) ]
    To compare the detection rates of right sided adenomas of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

  5. to determine cecal intubation time [ Time Frame: Through the study (1 year) ]
    To compare the cecal intubation time of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

  6. to determine insertion and withdrawal time [ Time Frame: Through the study (1 year) ]
    To compare the insertion and withdrawal time of the procedure of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

  7. to determine complications [ Time Frame: Through the study(1 year) ]
    To compare the complications of procedure of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Referral for screening or surveillance colonoscopy
  • Ability to provide informed consent

Exclusion Criteria:

  • Prior history of colon cancer
  • History of inflammatory bowel disease
  • Prior surgical resection of any part of the colon
  • Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
  • History of polyposis syndrome or HNPCC
  • Inability to give informed consent
  • Family history of colon cancer in a first degree relative < 60 years or two first degree relatives with colorectal cancer
Contacts and Locations

Contacts
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Contact: Prateek Sharma, MD (816) 861-4700 ext 56735 prateek.sharma@va.gov

Locations
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United States, Missouri
Kansas City VA Hospital Recruiting
Kansas City, Missouri, United States, 64128
Contact: April Higbee, RN, BSN    816-861-4700 ext 57456    april.higbee@va.gov   
Contact: Chandra Dasari, MD    816-861-4700 ext 55304      
Principal Investigator: Prateek Sharma, MD         
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Investigators
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Principal Investigator: Prateek Sharma, MD Kansas City VA Hospital
Tracking Information
First Submitted Date  ICMJE October 23, 2017
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE March 16, 2018
Estimated Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Adenoma detection rate [ Time Frame: Through the study (1 year) ]
To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Number of Adenomas per person [ Time Frame: Through the study (1 year) ]
    To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
  • detection rates of advanced adenomas [ Time Frame: Through the study (1 year) ]
    To compare the detection rates for advanced adenomas of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
  • detect rates of serrated polyps [ Time Frame: Through the study (1 year) ]
    To compare the detection rates for serrated polyps of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
  • detect rates of right sided adenomas [ Time Frame: Through the study (1 year) ]
    To compare the detection rates of right sided adenomas of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
  • to determine cecal intubation time [ Time Frame: Through the study (1 year) ]
    To compare the cecal intubation time of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
  • to determine insertion and withdrawal time [ Time Frame: Through the study (1 year) ]
    To compare the insertion and withdrawal time of the procedure of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
  • to determine complications [ Time Frame: Through the study(1 year) ]
    To compare the complications of procedure of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Three Arm Rand Trial of HD Light vs Reveal® Cap vs Endocuff Cap for Detection of Colorectal Adenomas (TRACE)
Official Title  ICMJE Three Arm Prospective Randomized Controlled Trial of HD White-light Colonoscopy vs HD White-light Colonoscopy With Reveal® Distal Attachment Cap Versus HD White-light Colonoscopy With Endocuff Vision for the Detection of Colorectal Adenomas
Brief Summary

Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas

Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone

Design: Multicenter, Prospective, randomized controlled study

Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

Detailed Description

Hypothesis and specific aims of the Study

We hypothesize that the detection rate of patients with colorectal adenomas will be higher with HDWL colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopy alone.

Primary Aim:

To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

Secondary Aims:

  1. To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
  2. To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

Methodology:

This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. They will be randomized to one of 3 arms, i.e. HDWL colonoscopy HDWL colonoscopy with Reveal® cap or HDWL colonoscopy with Endocuff Vision.

Enrollment:

A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.

Length of the study:

The duration of the study is expected to be approximately 12 months. Enrollment of study patients will cease when approximately 1227 patients have been enrolled.

Inclusion criteria

  • Referral for screening or surveillance colonoscopy
  • Ability to provide informed consent

Exclusion criteria

  • Prior history of colon cancer
  • History of inflammatory bowel disease
  • Prior surgical resection of any part of the colon
  • Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
  • History of polyposis syndrome or HNPCC
  • Inability to give informed consent
  • Family history of colon cancer in a first degree relative < 60 years or two first degree relatives with colorectal cancer

For three groups, moderate sedation will be administered in a standard fashion with intravenous midazolam, meperidine or fentanyl prior to undergoing colonoscopy.

The colonoscope (HDWL colonoscope or HDWL colonoscope with Reveal® cap or HDWL colonoscope with Endocuff Vision) will be inserted and cecum will be intubated. Photo documentation of the cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope.

The time from the point of insertion of the colonoscope into the rectum to the intubation of cecum will be recorded with a stop watch by a research coordinator and will be documented as the "insertion time".

The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the "withdrawal time". During withdrawal of the colonoscope the stop watch will be stopped whenever mucosa is being cleaned, fluid/solid debris is suctioned or a polyp is being removed to ensure that the withdrawal time is the actual representation of the mucosal inspection time. Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds, flexures and valves.

All polyps detected will be documented: size, location, and morphology (using the Paris classification - Appendix A). Photo documentation of the polyps will be performed.

Polyps will then be removed with a biopsy forceps or snare and sent for histopathological evaluation, each in a separate jar and labeled accordingly.

The bowel preparation will be evaluated and graded according to previously reported criteria using the Boston Bowel Preparation Scale (Appendix B). Complications including any mucosal trauma from the high definition colonoscope alone or with high definition colonoscope with Reveal® cap or Endocuff Vision, perforation or gastrointestinal bleeding (requiring intervention) will be recorded for three groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Three Arm Randomized Control Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Randomization will be done by computer allocation
Primary Purpose: Diagnostic
Condition  ICMJE Colorectal Adenoma
Intervention  ICMJE
  • Procedure: Colonoscopy
    Using an instrument called colonoscope which is used to detect colonic polyps
  • Device: distal Cap
    Using an instrument called cap at end of colonoscope which is used to straighten colon folds
  • Device: Endocuff
    Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
Study Arms  ICMJE
  • Active Comparator: High-Definition White-light Colonoscopy
    Using an instrument called colonoscope which is used to detect colonic polyps
    Intervention: Procedure: Colonoscopy
  • Active Comparator: High-Definition White-light Colonoscopy With Reveal®
    Using an instrument called cap at end of colonoscope which is used to straighten colon folds
    Interventions:
    • Procedure: Colonoscopy
    • Device: distal Cap
  • Active Comparator: High-Definition White-light Colonoscopy With Endocuff Vision
    Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
    Interventions:
    • Procedure: Colonoscopy
    • Device: Endocuff
Publications *
  • Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
  • Winawer SJ, Zauber AG, Fletcher RH, Stillman JS, O'Brien MJ, Levin B, Smith RA, Lieberman DA, Burt RW, Levin TR, Bond JH, Brooks D, Byers T, Hyman N, Kirk L, Thorson A, Simmang C, Johnson D, Rex DK; US Multi-Society Task Force on Colorectal Cancer; American Cancer Society. Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society. Gastroenterology. 2006 May;130(6):1872-85. Review.
  • Citarda F, Tomaselli G, Capocaccia R, Barcherini S, Crespi M; Italian Multicentre Study Group. Efficacy in standard clinical practice of colonoscopic polypectomy in reducing colorectal cancer incidence. Gut. 2001 Jun;48(6):812-5.
  • van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. Review.
  • 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.
  • Floer M, Biecker E, Fitzlaff R, Röming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Ströbel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.
  • Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.
  • Biecker E, Floer M, Heinecke A, Ströbel P, Böhme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
1227
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 10, 2020
Estimated Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Referral for screening or surveillance colonoscopy
  • Ability to provide informed consent

Exclusion Criteria:

  • Prior history of colon cancer
  • History of inflammatory bowel disease
  • Prior surgical resection of any part of the colon
  • Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
  • History of polyposis syndrome or HNPCC
  • Inability to give informed consent
  • Family history of colon cancer in a first degree relative < 60 years or two first degree relatives with colorectal cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Prateek Sharma, MD (816) 861-4700 ext 56735 prateek.sharma@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952611
Other Study ID Numbers  ICMJE RND#00978
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This is a multi- center study and we will receive de identified data from other centered via REDCAP
Responsible Party Midwest Veterans' Biomedical Research Foundation ( Midwest Biomedical Research Foundation )
Study Sponsor  ICMJE Midwest Biomedical Research Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prateek Sharma, MD Kansas City VA Hospital
PRS Account Midwest Veterans' Biomedical Research Foundation
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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