An interventional study of Chromoendoscopy with indigo carmine solution spray and Linked-color imaging endoscopy in Colonic Polyps, Adenomatous Polyps and Adenoma Detection Rate, sponsored by Shandong University. Recruiting at 1 site in China. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Shandong University · Not applicable, Interventional, and Diagnostic
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.
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.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 352 is above the median of 274 across 250 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Shandong University is the lead sponsor of 292 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group will be carefully observed with LCI endoscopy during the colonoscopy withdraw.
Procedure: Linked-color imaging endoscopy
Patients in this group will be carefully observed with spraying indigo carmine solution during the colonoscopy withdraw.
Procedure: Chromoendoscopy with indigo carmine solution spray
Patients will undergo chromoendoscopy with spraying indigo carmine.
Patients will undergo Linked-color imaging endoscopy.
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.
Time frame: Periprocedural
detected rate of different lesions
detected rate of different lesions（advanced adenoma, sessile serrated lesion） adenoma per colonoscopy (APC) withdrawal time adverse event rates
Time frame: Periprocedural
Started Apr 2025 (actual). Primary completion is estimated for Jan 2026, 9 months after the start.
Of 132 non-industry interventional studies with no phase under Colonic Polyps, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 9 months is below that.
Counting every sponsor, half of 149 studies reached it within 17 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.