Colonic PolypsNCT06961149
Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate
A study testing Chromoendoscopy with indigo carmine solution spray and Linked-color imaging endoscopy in people with Colonic Polyps and Adenomatous Polyps, run by Shandong University at 1 site in China.
Trial summary
Detection and removal of polyps during colonoscopy is crucial for the prevention of colorectal cancer. Indigo carmine spraying up to the colonic mucosa could probably increase the adenoma detection rate, but considering the long withdrawal time of the endoscope and the resulting increase in time and cost. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Colonic Polyps, Adenomatous Polyps, Adenoma Detection Rate
- What is being tested?
- Chromoendoscopy with indigo carmine solution spray and Linked-color imaging endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age between 45 and 85 years
- Patients with a history of colorectal adenoma
- Patients whose first-degree relatives have a history of colorectal cancer or colorectal adenoma
- Patients with gastrointestinal symptoms (abdominal pain, bloody stool, chronic diarrhea or constipation, Unexplained anemia or weight loss;
- Patients with positive Fecal Immunochemical Test
Who cannot join
- Patients with pregnancy, inflammatory bowel disease, familial adenomatosis polyposis, suspected CRC; intestinal obstruction, coagulopathy
- Patients with aspirin, clopidogrel or other anticoagulants/ antiplatelet drugs intake within 7 days
- Patents previous colorectal resection
- Patients with failed cecal intubation
- Patients with inadequate bowel preparation quality (BBPS≤5)
- Patients who refuse to participate or to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rui Ji MD PHD, +86-18560086103 contact
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Rui Ji MD PHD, +86-18560086103, qljirui@email.sdu.edu.cn
About this study
Official title: Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate: a Prospective , Randomized Controlled, Non-inferiority Study
Detection and removal of polyps during colonoscopy is crucial for the prevention of colorectal cancer. Indigo carmine spraying up to the colonic mucosa could probably increase the adenoma detection rate, but considering the long withdrawal time of the endoscope and the resulting increase in time and cost. Linked-color imaging (LCI) is a newly developed image-enhanced endoscopy technology. It relies on wave length optimization of three colors (red, green, and blue) to make the lesions appear fuller. LCI improves the visibility of colorectal adenomas and polyps and may increase the detection rate of lesions. In order to explore the clinical application value of Linked-color imaging endoscopy, we performed a prospective, randomized controlled trial to compare adenoma detection rate of Linked-color imaging endoscopy and indigo carmine chromoendoscopy.
Read the detailed description
If patients scheduled for colonoscopy meet the inclusion criteria but not the exclusion criteria, participants will be recruited to the study and randomized to one of two groups. Group allocation was revealed to endoscopists upon confirmation of cecal intubation. participants in Group A (treatment group) will undergo colonoscopy with LCI. participants in Group B (control group) will undergo spraying indigo carmine solution during withdrawal process. Any lesions found during the procedure will be removed and sent for pathological examination. The investigator will record the participants' general information (such as gender, age, symptoms, body mass index，etc.), colonoscopy data (such as duration etc.), and lesion characteristics (such as location, morphology, histopathological classification, etc.). All data were analyzed according to the ITT analysis, and the PP analysis was performed for all outcomes. Continuous variables were presented as means ± standard deviation (SD), and compared using Independent Samples t test. Categorical variables were expressed as frequency counts (percentages) and analyzed using Pearson's chi-square test or the Fisher exact test. Statistical analyses were performed using SPSS 27.0. Statistical significance was defined as P < 0.05.
- Conditions
- Colonic Polyps, Adenomatous Polyps, Adenoma Detection Rate, Chromoendoscopy, Colorectal Neoplasms
- Being tested
- Chromoendoscopy with indigo carmine solution spray, Linked-color imaging endoscopy
- Keywords
- Adenoma Detection Rate, Linked-color imaging, Chromoendoscopy, Colonoscopy, Indigo Carmine
- Medical subject headings
- Colonic Polyps, Adenomatous Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromoendoscopy with indigo carmine solution sprayProcedure or surgery
Patients will undergo chromoendoscopy with spraying indigo carmine.
Linked-color imaging endoscopyProcedure or surgery
Patients will undergo Linked-color imaging endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Linked-color imaging endoscopy | Experimental | Patients in this group will be carefully observed with LCI endoscopy during the colonoscopy withdraw. Receives: Procedure: Linked-color imaging endoscopy |
| Chromoendoscopy with indigo carmine solution spray | Active comparator | Patients in this group will be carefully observed with spraying indigo carmine solution during the colonoscopy withdraw. Receives: Procedure: Chromoendoscopy with indigo carmine solution spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate(ADR)
adenoma detection rate (ADR) defined as the percentage of patients with at least one histologically confirmed adenomatous polyp detected and resected during colonoscopy.
Measured: Periprocedural
Secondary outcomes (1)
detected rate of different lesions
detected rate of different lesions（advanced adenoma, sessile serrated lesion） adenoma per colonoscopy (APC) withdrawal time adverse event rates
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start8 Apr 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961149
- Sponsor's protocol ID
- KYLL-202502-013-1
- Status last verified
- May 2025
- First submitted
- 20 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate: a Prospective , Randomized Controlled, Non-inferiority Study
- ClinicalTrials.gov ID
- NCT06961149
- Acronym / sponsor ID
- KYLL-202502-013-1
- Conditions
- Colonic Polyps, Adenomatous Polyps, Adenoma Detection Rate, Chromoendoscopy, Colorectal Neoplasms
- Keywords
- Adenoma Detection Rate, Linked-color imaging, Chromoendoscopy, Colonoscopy, Indigo Carmine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 7 May 2025 (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.
Detection and removal of polyps during colonoscopy is crucial for the prevention of colorectal cancer. Indigo carmine spraying up to the colonic mucosa could probably increase the adenoma detection rate, but considering the long withdrawal time of the endoscope and the resulting increase in time and cost. Linked-color imaging (LCI) is a newly developed image-enhanced endoscopy technology. It relies on wave length optimization of three colors (red, green, and blue) to make the lesions appear fuller. LCI improves the visibility of colorectal adenomas and polyps and may increase the detection rate of lesions. In order to explore the clinical application value of Linked-color imaging endoscopy, we performed a prospective, randomized controlled trial to compare adenoma detection rate of Linked-color imaging endoscopy and indigo carmine chromoendoscopy.
Detailed description
If patients scheduled for colonoscopy meet the inclusion criteria but not the exclusion criteria, participants will be recruited to the study and randomized to one of two groups. Group allocation was revealed to endoscopists upon confirmation of cecal intubation. participants in Group A (treatment group) will undergo colonoscopy with LCI. participants in Group B (control group) will undergo spraying indigo carmine solution during withdrawal process. Any lesions found during the procedure will be removed and sent for pathological examination. The investigator will record the participants' general information (such as gender, age, symptoms, body mass index，etc.), colonoscopy data (such as duration etc.), and lesion characteristics (such as location, morphology, histopathological classification, etc.). All data were analyzed according to the ITT analysis, and the PP analysis was performed for all outcomes. Continuous variables were presented as means ± standard deviation (SD), and compared using Independent Samples t test. Categorical variables were expressed as frequency counts (percentages) and analyzed using Pearson's chi-square test or the Fisher exact test. Statistical analyses were performed using SPSS 27.0. Statistical significance was defined as P < 0.05.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linked-color imaging endoscopy | Experimental | Procedure: Linked-color imaging endoscopyPatients in this group will be carefully observed with LCI endoscopy during the colonoscopy withdraw. |
| Chromoendoscopy with indigo carmine solution spray | Active comparator | Procedure: Chromoendoscopy with indigo carmine solution sprayPatients in this group will be carefully observed with spraying indigo carmine solution during the colonoscopy withdraw. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 45 and 85 years
- Patients with a history of colorectal adenoma
- Patients whose first-degree relatives have a history of colorectal cancer or colorectal adenoma
- Patients with gastrointestinal symptoms (abdominal pain, bloody stool, chronic diarrhea or constipation, Unexplained anemia or weight loss;
- Patients with positive Fecal Immunochemical Test
Key exclusion criteria (6 listed)
- Patients with pregnancy, inflammatory bowel disease, familial adenomatosis polyposis, suspected CRC; intestinal obstruction, coagulopathy
- Patients with aspirin, clopidogrel or other anticoagulants/ antiplatelet drugs intake within 7 days
- Patents previous colorectal resection
- Patients with failed cecal intubation
- Patients with inadequate bowel preparation quality (BBPS≤5)
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 |
|---|---|---|
| Chromoendoscopy with indigo carmine solution sprayPatients will undergo chromoendoscopy with spraying indigo carmine. | Procedure or surgery | Chromoendoscopy with indigo carmine solution spray |
| Linked-color imaging endoscopyPatients will undergo Linked-color imaging endoscopy. | Procedure or surgery | Linked-color imaging endoscopy |
Primary outcome
adenoma detection rate(ADR)
Time frame: Periprocedural
adenoma detection rate (ADR) defined as the percentage of patients with at least one histologically confirmed adenomatous polyp detected and resected during colonoscopy.
1 secondary outcome
detected rate of different lesions
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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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.
Rui Ji MD PHD, +86-18560086103 contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromoendoscopy with indigo carmine solution spray and Linked-color imaging endoscopy in people with Colonic Polyps and Adenomatous Polyps, run by Shandong University at 1 site in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 May 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Ji MD PHD (+86-18560086103, qljirui@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate(ADR) (time frame: Periprocedural). 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 7 May 2025.