Adenoma Detection Rate of 3D Colonoscopy

NCT05153746 | Completed DMC

• 1 other identifier: 202109112DIPB
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

Adenoma detection rate (ADR) has been the most important quality indicator on colonoscopy because ADR was reversely related with CRC incidence and mortality. Several image enhanced technologies, such as narrow-band imaging (NBI) or linked colour imaging (LCI) had been proved to have ability to increase the ADR. 3D techonology, however, has not been validated on colonoscopy performance. Therefore, current study was to compare the ADR between new 3D colonoscopy and conventional 2D colonoscopy.

Conditions

Colorectal Neoplasms; Colorectal Cancer

Keywords

3D Colonoscopy; Colorectal neoplasm

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  The number of subjects with at least one adenomatous polyp found during the colonoscopy

  1 week

Secondary Outcomes (4)

• Proximal adenoma detection rate

  1 weeks

• Sessile serrated adenoma detection rate

  1 week

• Adenoma per colonoscopy (APC)

  1 week

• Flat adenoma detection rate

  1 week

Study Arms (2)

3D colonoscopy

EXPERIMENTAL

Colonoscopy insertion under regular method. After reaching cecum, the subjects will be randomized into 3D or conventional colonoscopy. Subjects in 3D colonoscopy arm: Colonoscopist will switch the image to 3D imaging form and wearing special glasses to enhance the 3D imaging. The 3D mode will be maintained during the whole colonoscopy withdrawal. When encountering suspicious neoplasm, the colonoscopist can use any image-enhancing technique (such as NBI or indigo carmine dye) to assist the diagnosis and use standard resection procedure (such as polypectomy) to complete lesion resection if necessary. The procedure time, withdrawal time, adenoma detection rate will be recorded during the colonoscopy. The pathology specimen will be sent for histology examination and any adverse event after colonoscopy (such as bleeding or perforation) will be recorded after routine surveillance.

Device: 3D colonoscopy

Conventional colonoscopy

ACTIVE COMPARATOR

Colonoscopy insertion under regular method. After reaching cecum, the subjects will be randomized into 3D or conventional colonoscopy. Subjects in conventional colonoscopy arm: Colonoscopist will use regular colonoscopy imaging form during the whole colonoscopy withdrawal. When encountering suspicious neoplasm, the colonoscopist can use any image-enhancing technique (such as NBI or indigo carmine dye) to assist the diagnosis and use standard resection procedure (such as polypectomy) to complete lesion resection if necessary. The procedure time, withdrawal time, adenoma detection rate will be recorded during the colonoscopy. The pathology specimen will be sent for histology examination and any adverse event after colonoscopy (such as bleeding or perforation) will be recorded after routine surveillance.

Device: 3D colonoscopy

Interventions

3D colonoscopy DEVICE

3D colonoscopy is a new device to enhance endoscopic imaging.

3D colonoscopy; Conventional colonoscopy

Eligibility Criteria

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

You may qualify if:

• Age 40 or above
• Indication for colonoscopy, including screening, surveillance, symptomatic, etc

You may not qualify if:

• Poor and inadequate bowel preparation
• Incomplete study because of obstructive lesion, including cancer, stenosis, etc.
• Failure of cecal intubation, difficult insertion
• Inflammatory bowel disease
• Hereditary polyposis, (FAP, Lynch syndrome, hyperplastic polyposis, etc.)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Li-Chun Chang, AP

  National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3D-colonoscopy vs. conventional 2D-colonoscopy Setting: Multi-centers Eligibility: Age 40 or above Indication for colonoscopy, including screening, surveillance, symptomatic, etc Exclusion: Poor and inadequate bowel preparation Incomplete study because of obstructive lesion, including cancer, stenosis, etc. Failure of cecal intubation, difficult insertion Inflammatory bowel disease Hereditary polyposis, (FAP, Lynch syndrome, hyperplastic polyposis, etc.)

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: February 10, 2022
• Primary Completion: May 23, 2023
• Study Completion: June 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)