Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group

Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group: a Multi-center, Randomized Controlled Trial

Background:

Adenoma detection rate is one of the most quality indicator: an accumulating body of evidence has shown that detection and resection of pre-cancerous adenoma by colonoscopy could effectively prevent colorectal cancer (CRC) and its related mortality1,2. Among various colonoscopy quality indicators, such as cecal intubation rate, withdrawal time, and adenoma detection rate (ADR), ADR is the most important one and most closely associated with the subsequent risk of CRC3,4. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC5.

Equipment and technique to improve ADR: To be noted, among all colorectal neoplasm, non-polypoid lesions, such as flat or depressed lesions, carries higher likelihood to be overlooked during conventional colonoscopy and these overlooked lesions were the main etiology of post-colonoscopy colorectal cancer (PCCRC)6. Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy7 or add-on device such as Cap/Endocuff/third eye/FUSE-assisted endoscopy8. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI9 or iSCAN10.

Application of 3D endoscopy on GI disease: 3D endoscopy is a new technology that using image processing technique to offer more information on tissue depth in comparison with conventional 2D endoscopy. The utility of 3D endoscopy on GI tract was mainly from upper GI tract and it was proved to enhance the diagnostic accuracy on superficial gastric tumors11 and shortened the procedure time during performing gastric endoscopic submucosal dissection (ESD)12. However, few is known that whether 3D colonoscopy could enhance the ADR, especially for non-polypoid lesion detection, during colonoscopy examination.

Positive fecal immunochemical test(FIT) group Among subjects who receive colonoscopy examination, higher advanced adenoma or invasive caners were found in FIT positive group. However, still about half of positive FIT subjects who received colonoscopy exam, have negative colonoscopy result. Non polypoid lesions could be overlooked during the colonoscopy. Therefore, we tried to use this prospective, multicenter, randomized control study to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy in this kind of high risk group.

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy; Adenoma Detection Rate; Fecal Immunochemical Test; Three Dimensional
• Intervention / Treatment: Device: 3D device

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsuan-Ho Lin, MD; Phone Number: 886-9-72-654-359; Email: tostart21@gmail.com

Study Locations

• Taiwan
  • Hsin-Chu, Taiwan
    • Recruiting
    • National Taiwan University Hospital, Hsinchu Branch
    • Contact: Hsuan-Ho Lin; Phone Number: 886-9-72-654-359; Email: tostart21@gmail.com
    • Contact: Hsuan-Ho Lin, MD
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Li-Chun Chang, MD. PhD.; Phone Number: 886-9-72-651-258; Email: lichunchang@ntu.edu.tw
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Cancer Center
    • Contact: Hao-Che Chang, MD; Phone Number: 886-2-23123456; Email: andrewhcchang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects who are 40 years of older
• Subjects who have positive fecal immunochemical test

Exclusion Criteria:

• Contraindication for colonoscopy
• Subjects with familiar or hereditary polyposis
• Subjects with history of colectomy
• Inadequate bowel cleansing level
• Subjects with inflammatory bowel disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D colonoscopy; Use 3D machine to generate the 3D image	Device: 3D device; Use 3D machine to generate the 3D image
No Intervention: 2D colonoscopy; Traditional colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adenoma detection rate	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flat-ADR	detection rate of flat adenoma	30 minutes
Proximal ADR	detection rate of adenoma at proximal colon	30 minutes
SSLDR	detection rate of sessile serrated lesion	30 minutes
AADR	detection rate of advanced adenoma	30 minutes
Polyp detection rate		30 minutes
adenoma number per colonoscopy,		30 minutes
polyp number per colonoscopy,		30 minutes

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: colonoscopy; adenoma detection rate; 3D; Fecal immunochemical test
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 202311028DIPA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No