Colorectal NeoplasmsNCT05153746
Adenoma Detection Rate of 3D Colonoscopy
A study testing 3D colonoscopy in people with Colorectal Neoplasms and Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Cancer
- What is being tested?
- 3D colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Feb 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 or above
- Indication for colonoscopy, including screening, surveillance, symptomatic, etc
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Neoplasms, Colorectal Cancer
- Being tested
- 3D colonoscopy
- Keywords
- 3D Colonoscopy, Colorectal neoplasm
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D colonoscopyDevice
3D colonoscopy is a new device to enhance endoscopic imaging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 3D colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The number of subjects with at least one adenomatous polyp found during the colonoscopy
Measured: 1 week
Secondary outcomes (4)
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
Measured: 1 weeks
Sessile serrated adenoma detection rate
The number of subjects with at least one sessile serrated adenomatous polyp found during the colonoscopy
Measured: 1 week
Adenoma per colonoscopy (APC)
Average adenomatous polyps number found in each colonoscopy
Measured: 1 week
Flat adenoma detection rate
The number of subjects with at least one flat adenomatous polyp found during the colonoscopy
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start10 Feb 2022
- Primary completion23 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Chun Chang, AP, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153746
- Sponsor's protocol ID
- 202109112DIPB
- Status last verified
- May 2023
- First submitted
- 29 Nov 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adenoma Detection Rate Between Conventional Colonoscopy and 3D Colonoscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05153746
- Acronym / sponsor ID
- 202109112DIPB
- Conditions
- Colorectal Neoplasms, Colorectal Cancer
- Keywords
- 3D Colonoscopy, Colorectal neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.)
| Arm | Type | Receives |
|---|---|---|
| 3D colonoscopy | Experimental | Device: 3D colonoscopyColonoscopy 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. |
| Conventional colonoscopy | Active comparator | Device: 3D colonoscopyColonoscopy 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 40 or above
- Indication for colonoscopy, including screening, surveillance, symptomatic, etc
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D colonoscopy3D colonoscopy is a new device to enhance endoscopic imaging. | Device | 3D colonoscopy, Conventional colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: 1 week
The number of subjects with at least one adenomatous polyp found during the colonoscopy
4 secondary outcomes
Proximal adenoma detection rate
Time frame: 1 weeks
Sessile serrated adenoma detection rate
Time frame: 1 week
Adenoma per colonoscopy (APC)
Time frame: 1 week
Flat adenoma detection rate
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. No IPD sharing plan
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Chun Chang, AP study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D colonoscopy in people with Colorectal Neoplasms and Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.