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Adenoma Detection Rate of 3D Colonoscopy

Primary Purpose

Colorectal Neoplasms, Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
3D colonoscopy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasms focused on measuring 3D Colonoscopy, Colorectal neoplasm

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3D colonoscopy

Conventional colonoscopy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2021
Last Updated
August 13, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05153746
Brief Title
Adenoma Detection Rate of 3D Colonoscopy
Official Title
Comparison of Adenoma Detection Rate Between Conventional Colonoscopy and 3D Colonoscopy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Colorectal Cancer
Keywords
3D Colonoscopy, Colorectal neoplasm

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.)
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D colonoscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional colonoscopy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
3D colonoscopy
Intervention Description
3D colonoscopy is a new device to enhance endoscopic imaging.
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
The number of subjects with at least one adenomatous polyp found during the colonoscopy
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Proximal adenoma detection rate
Description
The number of subjects with at least one adenomatous polyp found at proximal colon ( cecum, ascending colon and hepatic flexure) during the colonoscopy
Time Frame
1 weeks
Title
Sessile serrated adenoma detection rate
Description
The number of subjects with at least one sessile serrated adenomatous polyp found during the colonoscopy
Time Frame
1 week
Title
Adenoma per colonoscopy (APC)
Description
Average adenomatous polyps number found in each colonoscopy
Time Frame
1 week
Title
Flat adenoma detection rate
Description
The number of subjects with at least one flat adenomatous polyp found during the colonoscopy
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Chun Chang, AP
Phone
09726-51258
Email
lichunchang@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Yuan Chang, Lecturer
Phone
09726-52906
Email
wychang1005@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Chun Chang, AP
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Chun Chang, AP
Phone
097261258
Email
lichunchang@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Wei-Yuan Chang, Lecturer
Phone
0972652906
Email
wychang1005@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD sharing plan
Citations:
PubMed Identifier
33010298
Citation
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Results Reference
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Citation
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Citation
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Results Reference
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Adenoma Detection Rate of 3D Colonoscopy

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