AdenomaNCT06515977
Texture and Colour Enhancement Imaging in Improving Detection and Miss Rate of Premalignant Lesions
A study testing TXI (Group A), TXI followed by WLI (Group B) and WLI (Group C) in people with Adenoma and Sessile Serrated Adenoma, run by Changhai Hospital.
Trial summary
Texture and Color Enhancement Imaging (TXI) is a newly developed image-enhancing endoscopy technology that has show potential in improving detection of colorectal lesions. This multicenter, randomized, tandem trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of diagnosis of premalignant… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Adenoma, Sessile Serrated Adenoma
- What is being tested?
- TXI (Group A), TXI followed by WLI (Group B) and WLI (Group C)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,964 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2025
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 45-85 years and scheduled for screening colonoscopy who provided written informed consent
Who cannot join
- Surveillance, diagnostic or therapeutic colonoscopy
- Patients with an already known or suspected colorectal tumour
- Patients with alarming symptoms and signs, including haematochezia, melena, weight loss or anaemia without specific causes, an abdominal mass and positive digital rectal examination
- Pregnant or lactating women
- Patients with gastrointestinal tract obstruction
- Patients with inflammatory bowel diseases, hereditary CRC syndromes or serrated polyposis syndrome
Show all 10Show fewer
- Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
- Patients with failed cecal intubation
- Patients with poor bowel preparation quality that necessitated a second bowel preparation
- Patients with a history of colonic resection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Texture and Color Enhancement Imaging on Detection and Miss Rate of Premalignant Lesions: A Multicentre, Randomized, Tandem Trial
Texture and Color Enhancement Imaging (TXI) is a newly developed image-enhancing endoscopy technology that has show potential in improving detection of colorectal lesions. This multicenter, randomized, tandem trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of diagnosis of premalignant lesions.
- Conditions
- Adenoma, Sessile Serrated Adenoma
- Being tested
- TXI (Group A), TXI followed by WLI (Group B), WLI (Group C), WLI followed by TXI (Group D)
- Keywords
- texture and color enhancement imaging, colonoscopy, adenoma detection rate, sessile serrated lesion detection rate, adenoma miss rate, sessile serrated lesion miss rate
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TXI (Group A)Procedure or surgery
Patients in Group A will undergo colonoscopy with TXI.
TXI followed by WLI (Group B)Procedure or surgery
Patients in group B will first undergo colonoscopy with TXI and every polyp found should be removed. Then switch to WLI for a second withdrawal to detect lesions that were not observed the first time.
WLI (Group C)Procedure or surgery
Patients in Group C will undergo colonoscopy with WLI.
WLI followed by TXI (Group D)Procedure or surgery
Patients in group D will first undergo colonoscopy with WLI and every polyp found should be removed. Then switch to TXI for a second withdrawal to detect lesions that were not observed the first time.
| Study group | Role | What they receive |
|---|---|---|
| TXI (Group A) | Experimental | Arm undergoing colonoscopy with TXI Receives: Procedure: TXI (Group A) |
| TXI followed by WLI (Group B) | Experimental | Arm undergoing initial inspection under TXI first, followed by second inspection with WLI Receives: Procedure: TXI followed by WLI (Group B) |
| WLI (Group C) | Active comparator | Arm undergoing normal colonoscopy with WLI Receives: Procedure: WLI (Group C) |
| WLI followed by TXI (Group D) | Active comparator | Arm undergoing initial inspection under WLI first, followed by second inspection with TXI Receives: Procedure: WLI followed by TXI (Group D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
the number of patients with one or more adenomas detected and removed divided by the total number of patient
Measured: 1 years
sessile serrated lesion detection rate
the number of patients with one or more sessile serrated lesions detected and removed divided by the total number of patients
Measured: 1 years
Secondary outcomes (2)
adenoma miss rate
the number of adenomas detected during the second examination divided by the total number of adenomas detected during the first and second colonoscopy
Measured: 1 years
sessile serrated lesion miss rate
the number of sessile serrated lesions detected during the second examination divided by the total number of sessile serrated lesions detected during the first and second colonoscopy
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AdenomaStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,964 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Dalian Medical University, The Second Hospital of Hebei Medical University, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Huadong Hospital, Shanghai 6th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The General Hospital of Eastern Theater Command, Jiangsu Provincial People's Hospital, First People's Hospital of Hangzhou, Wenzhou Central Hospital, The First Affiliated Hospital of Nanchang University, Shanxi Coal Center Hospital, Dalian Municipal Central Hospital, Seventh Medical Center of PLA Army General Hospital, Henan Provincial People's Hospital, Zunyi Medical College, Shandong Provincial Hospital, The Third People's Hospital of Chengdu, Lanzhou University Second Hospital, The Third People's Hospital of Jingdezhen, Fudan University Attached Tumor Hospital, Qingyuan People's Hospital
- Responsible party
- Sponsor
- Investigators
- Zhaoshen Li, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515977
- Sponsor's protocol ID
- TADR-2024
- Status last verified
- Jun 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wei J, Zhao S, Bai Y. Impact of Texture and Color Enhancement Imaging on Adenoma and Sessile Serrated Lesion Detection: Much More to Explore. Gastroenterology. 2024 Jul;167(2):413-414. doi: 10.1053/j.gastro.2024.01.014. Epub 2024 Jan 13. No abstract available.
PubMed 38224857Antonelli G, Bevivino G, Pecere S, Ebigbo A, Cereatti F, Akizue N, Di Fonzo M, Coppola M, Barbaro F, Walter BM, Sharma P, Caruso A, Okimoto K, Antenucci C, Matsumura T, Zerboni G, Grossi C, Meinikheim M, Papparella LG, Correale L, Costamagna G, Repici A, Spada C, Messmann H, Hassan C, Iacopini F. Texture and color enhancement imaging versus high definition white-light endoscopy for detection of colorectal neoplasia: a randomized trial. Endoscopy. 2023 Dec;55(12):1072-1080. doi: 10.1055/a-2129-7254. Epub 2023 Jul 14.
PubMed 37451283Young E, Rajagopalan A, Tee D, Sathananthan D, Hoile S, Singh R. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14.
PubMed 37839498
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Texture and Color Enhancement Imaging on Detection and Miss Rate of Premalignant Lesions: A Multicentre, Randomized, Tandem Trial
- ClinicalTrials.gov ID
- NCT06515977
- Acronym / sponsor ID
- TADR-2024
- Conditions
- Adenoma, Sessile Serrated Adenoma
- Keywords
- texture and color enhancement imaging, colonoscopy, adenoma detection rate, sessile serrated lesion detection rate, adenoma miss rate, sessile serrated lesion miss rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,964 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Dalian Medical University, The Second Hospital of Hebei Medical University, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Huadong Hospital, Shanghai 6th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The General Hospital of Eastern Theater Command, Jiangsu Provincial People's Hospital, First People's Hospital of Hangzhou, Wenzhou Central Hospital, The First Affiliated Hospital of Nanchang University, Shanxi Coal Center Hospital, Dalian Municipal Central Hospital, Seventh Medical Center of PLA Army General Hospital, Henan Provincial People's Hospital, Zunyi Medical College, Shandong Provincial Hospital, The Third People's Hospital of Chengdu, Lanzhou University Second Hospital, The Third People's Hospital of Jingdezhen, Fudan University Attached Tumor Hospital, Qingyuan People's Hospital
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 23 Jul 2024 (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.
Texture and Color Enhancement Imaging (TXI) is a newly developed image-enhancing endoscopy technology that has show potential in improving detection of colorectal lesions. This multicenter, randomized, tandem trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of diagnosis of premalignant lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TXI (Group A) | Experimental | Procedure: TXI (Group A)Arm undergoing colonoscopy with TXI |
| TXI followed by WLI (Group B) | Experimental | Procedure: TXI followed by WLI (Group B)Arm undergoing initial inspection under TXI first, followed by second inspection with WLI |
| WLI (Group C) | Active comparator | Procedure: WLI (Group C)Arm undergoing normal colonoscopy with WLI |
| WLI followed by TXI (Group D) | Active comparator | Procedure: WLI followed by TXI (Group D)Arm undergoing initial inspection under WLI first, followed by second inspection with TXI |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged 45-85 years and scheduled for screening colonoscopy who provided written informed consent
Key exclusion criteria (10 listed)
- Surveillance, diagnostic or therapeutic colonoscopy
- Patients with an already known or suspected colorectal tumour
- Patients with alarming symptoms and signs, including haematochezia, melena, weight loss or anaemia without specific causes, an abdominal mass and positive digital rectal examination
- Pregnant or lactating women
- Patients with gastrointestinal tract obstruction
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 |
|---|---|---|
| TXI (Group A)Patients in Group A will undergo colonoscopy with TXI. | Procedure or surgery | TXI (Group A) |
| TXI followed by WLI (Group B)Patients in group B will first undergo colonoscopy with TXI and every polyp found should be removed. Then switch to WLI for a second withdrawal to detect lesions that were not observed the first time. | Procedure or surgery | TXI followed by WLI (Group B) |
| WLI (Group C)Patients in Group C will undergo colonoscopy with WLI. | Procedure or surgery | WLI (Group C) |
| WLI followed by TXI (Group D)Patients in group D will first undergo colonoscopy with WLI and every polyp found should be removed. Then switch to TXI for a second withdrawal to detect lesions that were not observed the first time. | Procedure or surgery | WLI followed by TXI (Group D) |
Primary outcome
adenoma detection rate
Time frame: 1 years
the number of patients with one or more adenomas detected and removed divided by the total number of patient
sessile serrated lesion detection rate
Time frame: 1 years
the number of patients with one or more sessile serrated lesions detected and removed divided by the total number of patients
2 secondary outcomes
adenoma miss rate
Time frame: 1 years
sessile serrated lesion miss rate
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 38224857Wei J, Zhao S, Bai Y. Impact of Texture and Color Enhancement Imaging on Adenoma and Sessile Serrated Lesion Detection: Much More to Explore. Gastroenterology. 2024 Jul;167(2):413-414. doi: 10.1053/j.gastro.2024.01.014. Epub 2024 Jan 13. No abstract available.
- Background: PubMed 37451283Antonelli G, Bevivino G, Pecere S, Ebigbo A, Cereatti F, Akizue N, Di Fonzo M, Coppola M, Barbaro F, Walter BM, Sharma P, Caruso A, Okimoto K, Antenucci C, Matsumura T, Zerboni G, Grossi C, Meinikheim M, Papparella LG, Correale L, Costamagna G, Repici A, Spada C, Messmann H, Hassan C, Iacopini F. Texture and color enhancement imaging versus high definition white-light endoscopy for detection of colorectal neoplasia: a randomized trial. Endoscopy. 2023 Dec;55(12):1072-1080. doi: 10.1055/a-2129-7254. Epub 2023 Jul 14.
- Background: PubMed 37839498Young E, Rajagopalan A, Tee D, Sathananthan D, Hoile S, Singh R. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14.
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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.
Zhaoshen Li, MD principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TXI (Group A), TXI followed by WLI (Group B) and WLI (Group C) in people with Adenoma and Sessile Serrated Adenoma, run by Changhai Hospital.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoshen Li, MD (86-021-31161365, li.zhaoshen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate (time frame: 1 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515977, which also lists 3 linked publications.
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 23 Jul 2024.