Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network (CapACE)

Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection of Colorectal Neoplasia

The investigators plan to conduct a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyp. This study will be performed using web-based research network, e-VELOS in Korea.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasm
• Intervention / Treatment: Device: cap-assisted chromoendoscopy

Detailed Description

Various endoscopic tools have been tried to reduce polyp missing rate which has been reported to be 20-25%. Transparent cap-assisted colonoscopy has been suggested to improve visualization of the lesion that are difficult to access, such as tangentially located lesions and those located within a limited luminal space. Chromoendoscopy with indigocarmine spraying was reported to increases the detection rates of polyp, especially in right colon and rectum. However, there also have been mixed results regarding polyp detection rates of the endoscopic methods. Moreover, there is no data regarding the impact of the screening tools on longterm recurrence rate of colorectal polyp. Therefore, in this study, we intend to perform a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyps. This study will be performed using web-based research network, e-VELOS in Korea.

• Study Type: Interventional
• Enrollment (Actual): 1905
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Medical Center
  • Busan, Korea, Republic of
    • Kosin University College of Medicine
  • Cheonan, Korea, Republic of
    • Dankuk University college of medicine hospital
  • Goyang, Korea, Republic of
    • National Cancer Center Hospital, National Cancer Center
  • Guri-si, Korea, Republic of
    • Hanyang University Guri Hospital, Hanyang University College of Medicine
  • Incheon, Korea, Republic of
    • Catholic university St. Mari's hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center, Sungkyunkwan University School of Medicine
  • Seoul, Korea, Republic of
    • Yonsei University College of Medicine
  • Seoul, Korea, Republic of
    • Asan Medical Center, University of Ulsan College of Medicine
  • Seoul, Korea, Republic of
    • Ewha Mokdong hospital
  • Seoul, Korea, Republic of
    • Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine
  • Seoul, Korea, Republic of
    • Sunchunhyang University hospital
  • Seoul, Korea, Republic of
    • Sungkyunkwan University Kangbuk Samsung Hospital
  • Wonju, Korea, Republic of
    • Yonsei Uiniversity Wonju College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All asymptomatic colonoscopic examinees

Exclusion Criteria:

• Familial history of hereditary colorectal cancer
• History of colorectal cancer
• Patients had received colonoscopy examination before
• Familial or past history of FAP(familiar adenomatous polyposis)
• Colonic polyposis syndrome
• Prior colonic resection of any part of the colon
• Allergy to indigo carmine
• Inflammatory bowel disease
• Pregnancy
• Inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cap-assisted chromoendoscopy; To the tip of the colonoscope, transparent cap is fitted and applied. In addition, panchromoendoscopy using indigocarmine solution is preformed in this group.	Device: cap-assisted chromoendoscopy; A cap (irrigation cap) is a simple plastic device that can be attached to the tip of a colonoscope before performing the colonoscopy. For chromoendoscopy, 0.09% indigocarmine was administered via irrigation cap .
No Intervention: Standard colonoscopy; Neither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	The proportion of subjects with at least one adenoma	7 days is needed to confirm the pathologic examination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proximal adenoma detection rate	Proportion of subjects with at least one proximal colon adenoma	7 days is needed to confirm the pathologic examination.
Proximal serrated polyp detection rate	Proportion of subjects with at least one proximal serrated polyp/adenoma	7 days is needed to confirm the pathologic examination.
Advanced adenoma detection rate	Proportion of subjects with at least one advanced adenoma	7 days is needed to confirm the pathologic examination.
Serrated adenoma detection rate	Proportion of subjects with at least one serrated adenoma	7 days is needed to confirm the pathologic examination.
Cancer detection rate	Proportion of subjects with at least one cancer	7 days is needed to confirm the pathologic examination.
Surveillance	Surveillance interval recommendations for both groups were classified based on adenoma detection	7 - 14 days

Collaborators and Investigators

• Sponsor: Korean Association for the Study of Intestinal Diseases
• Collaborators: National Cancer Center, Korea; Ministry of Health & Welfare, Korea
• Investigators: Principal Investigator: Hyun Soo Kim, Korean Association for the Study of Intestinal Diseases

Publications and helpful links

General Publications

• Kim SY, Park HJ, Kim HS, Park DI, Cha JM, Park SJ, Choi H, Shin JE, Eun CS, Kim JO, Kim HG, Kim SE, Park CH, Kim TI, Hong SN. Cap-Assisted Chromoendoscopy Using a Mounted Cap Versus Standard Colonoscopy for Adenoma Detection. Am J Gastroenterol. 2020 Mar;115(3):465-472. doi: 10.14309/ajg.0000000000000510.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: April 27, 2010
• First Posted (Estimate): April 28, 2010

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Colonoscopy; Colorectal neoplasm; chromoendoscopy; cap-assisted colonoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: KASID polyp-01; MHWFA A092230 (Other Grant/Funding Number: Ministry of Health, Welfare & Family Affairs, Korea)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED