Adenoma Detection Rate of 3D Colonoscopy

September 17, 2024 updated by: National Taiwan University Hospital

Comparison of Adenoma Detection Rate Between Conventional Colonoscopy and 3D Colonoscopy: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 mortality. 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 CRC. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC.

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). Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy or add-on device such as Cap-assisted endoscopy. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI or iSCAN.

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 tumors and shortened the procedure time during performing gastric endoscopic submucosal dissection(ESD). However, few is known that whether 3D colonoscopy could enhance the adenoma detection, especially for non-polypoid lesion detection, during colonoscopy examination. Therefore, this prospective, randomized control study is aim to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy.

Study Type

Interventional

Enrollment (Actual)

318

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D colonoscopy

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
3D colonoscopy is a new device to enhance endoscopic imaging.
Active Comparator: Conventional colonoscopy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: 1 week
The number of subjects with at least one adenomatous polyp found during the colonoscopy
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma per colonoscopy (APC)
Time Frame: 1 week
Average adenomatous polyps number found in each colonoscopy
1 week
Flat adenoma detection rate
Time Frame: 1 week
The number of subjects with at least one flat adenomatous polyp found during the colonoscopy
1 week
Proximal adenoma detection rate
Time Frame: 1 weeks
The number of subjects with at least one adenomatous polyp found at proximal colon ( cecum, ascending colon and hepatic flexure) during the colonoscopy
1 weeks
Sessile serrated adenoma detection rate
Time Frame: 1 week
The number of subjects with at least one sessile serrated adenomatous polyp found during the colonoscopy
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Li-Chun Chang, AP, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Actual)

May 23, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202109112DIPB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD sharing plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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