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

NCT06678477 | Recruiting DMC

• 1 other identifier: 202311028DIPA
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Adenoma Detection Rate; Colonoscopy; Three Dimensional; Fecal Immunochemical Test

Keywords

colonoscopy; adenoma detection rate; 3D; Fecal immunochemical test

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  30 minutes

Secondary Outcomes (7)

• Flat-ADR

  30 minutes

• Proximal ADR

  30 minutes

• SSLDR

  30 minutes

• AADR

  30 minutes

• Polyp detection rate

  30 minutes

Study Arms (2)

3D colonoscopy

EXPERIMENTAL

Use 3D machine to generate the 3D image

Device: 3D device

2D colonoscopy

NO INTERVENTION

Traditional colonoscopy

Interventions

3D device DEVICE

Use 3D machine to generate the 3D image

3D colonoscopy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (3)

National Taiwan University Cancer Center

Taipei, Taiwan, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

RECRUITING

National Taiwan University Hospital, Hsinchu Branch

Taoyuan District, Taiwan, Taiwan

RECRUITING

Central Study Contacts

Hsuan-Ho Lin, MD

CONTACT

886-9-72-654-359; tostart21@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 3D colonoscopy versus standard 2D colonoscopy in positive FIT groups

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

TW (3)