Colonic PolypsNCT06596317
Impact of Indigo Carmine Pump Spraying on the Adenoma Detection Rate
A study testing Chromoendoscopy and Conventional colonoscopy 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. 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 and Conventional colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2024to 30 Dec 2024
- 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 with a history of colorectal cancer or 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 occult blood tests
Who cannot join
- Patients with severe comorbidity
- Patients who are not suitable for colonoscopy
- Patients who received urgent or therapeutic colonoscopy
- Patients with pregnancy, inflammatory bowel disease, polyposis syndromes, suspected CRC; intestinal obstruction, coagulopathy
- Patients with aspirin, clopidogrel or other anticoagulants/ antiplatelet drugs intake within 7 days
- Patients with failed cecal intubation
- Patients with inadequate bowel preparation quality (Boston score ≤5)
- Patients who refuse to participate or to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Indigo Carmine Pump Spraying on the Adenoma Detection Rate: A Randomized Controlled Trial
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. The traditional method of dye spraying with spraying catheter or syringe would consume a lot of time and dye volume. Now, the more convenient auxiliary water supply channel can be used to spray indigo carmine. In order to explore the clinical application value of spraying indigo carmine solution by auxiliary water channel in high-risk population, we performed a prospective, randomized controlled trial to compare adenoma detection rate of conventional colonoscopy and chromoendoscopy.
Read the detailed description
If patients scheduled for colonoscopy meet the inclusion criteria but not the exclusion criteria, he or she will be recruited to the study and randomized to one of two groups. Subjects in Group A (treatment group) will undergo colonoscopy with spraying indigo carmine solution during withdrawal process. Subjects in Group B (control group) will undergo a standard conventional colonoscopy without spraying any solution during withdrawal process. The traditional method of dye spraying with spraying catheter or syringe would consume a lot of time and dye volume. The solution spraying process was implemented by a water jet channel using auxiliary foot pump. Any lesions found during the procedure will be removed and sent for pathological examination. The investigator will record the patient's general information (such as gender, age, symptoms, body mass index， etc.), colonoscopy data (such as duration, dye amount, etc.), and lesion characteristics (such as location, morphology, histopathological classification, etc.). Randomization was done with SPSS program. 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 the Student t test. Categorical data were expressed as number with percentage and analyzed using the chi-squared test or the Fisher exact test. All statistical analyses were performed using IBM SPSS Statistics or R Statistics, and 2-sided P<0.05 was statistically significant.
- Conditions
- Colonic Polyps, Adenomatous Polyps, Adenoma Detection Rate, Chromoendoscopy, Colorectal Neoplasms
- Being tested
- Chromoendoscopy, Conventional colonoscopy
- Keywords
- Adenoma Detection Rate, Chromoendoscopy, Colonoscopy, Colorectal Cancer, Indigo Carmine, Mean Adenoma Per Patient
- 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.
ChromoendoscopyProcedure or surgery
Patients will undergo chromoendoscopy with spraying indigo carmine.
Conventional colonoscopyProcedure or surgery
Patients will undergo conventional colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Chromoendoscopy with indigo carmine solution spray | Experimental | Patients in this group will be carefully observed with spraying indigo carmine solution during the colonoscopy withdraw. Receives: Procedure: Chromoendoscopy |
| Conventional colonoscopy without indigo carmine solution spray | Active comparator | Patients in this group will be carefully observed without spraying anything during the colonoscopy withdraw. Receives: Procedure: Conventional colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate(ADR)
ADR was calculated as the number of patients with at least one adenoma divided by the total number of patients. In other words, the adenoma detection rate of the sample was the proportion of patients with adenoma detected.
Measured: procedure time
Secondary outcomes (1)
detected rate of different lesions
Lesions are classified according to their size, location, morphology and histopathology, the corresponding detection rate was calculated as secondary outcome measures.
Measured: procedure time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start11 Jan 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Rui Ji, MD, PHD, Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596317
- Sponsor's protocol ID
- 2022SDU-QILU-294
- Status last verified
- Mar 2025
- First submitted
- 12 Apr 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tian H, Cui C, Wang Q, Zhang R, Sun Y, Zhang M, Ji R. The Efficacy of Pan-Indigo Carmine Chromoendoscopy by Water-Jet Pump in the Detection of Colorectal Lesions: A Randomized Controlled Trial. J Gastroenterol Hepatol. 2026 Aug;41(8):2329-2337. doi: 10.1111/jgh.70504. Epub 2026 Jun 23.
PubMed 42333873
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Indigo Carmine Pump Spraying on the Adenoma Detection Rate: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06596317
- Acronym / sponsor ID
- 2022SDU-QILU-294
- Conditions
- Colonic Polyps, Adenomatous Polyps, Adenoma Detection Rate, Chromoendoscopy, Colorectal Neoplasms
- Keywords
- Adenoma Detection Rate, Chromoendoscopy, Colonoscopy, Colorectal Cancer, Indigo Carmine, Mean Adenoma Per Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 19 Sep 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.
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. The traditional method of dye spraying with spraying catheter or syringe would consume a lot of time and dye volume. Now, the more convenient auxiliary water supply channel can be used to spray indigo carmine. In order to explore the clinical application value of spraying indigo carmine solution by auxiliary water channel in high-risk population, we performed a prospective, randomized controlled trial to compare adenoma detection rate of conventional colonoscopy and chromoendoscopy.
Detailed description
If patients scheduled for colonoscopy meet the inclusion criteria but not the exclusion criteria, he or she will be recruited to the study and randomized to one of two groups. Subjects in Group A (treatment group) will undergo colonoscopy with spraying indigo carmine solution during withdrawal process. Subjects in Group B (control group) will undergo a standard conventional colonoscopy without spraying any solution during withdrawal process. The traditional method of dye spraying with spraying catheter or syringe would consume a lot of time and dye volume. The solution spraying process was implemented by a water jet channel using auxiliary foot pump. Any lesions found during the procedure will be removed and sent for pathological examination. The investigator will record the patient's general information (such as gender, age, symptoms, body mass index， etc.), colonoscopy data (such as duration, dye amount, etc.), and lesion characteristics (such as location, morphology, histopathological classification, etc.). Randomization was done with SPSS program. 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 the Student t test. Categorical data were expressed as number with percentage and analyzed using the chi-squared test or the Fisher exact test. All statistical analyses were performed using IBM SPSS Statistics or R Statistics, and 2-sided P<0.05 was statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chromoendoscopy with indigo carmine solution spray | Experimental | Procedure: ChromoendoscopyPatients in this group will be carefully observed with spraying indigo carmine solution during the colonoscopy withdraw. |
| Conventional colonoscopy without indigo carmine solution spray | Active comparator | Procedure: Conventional colonoscopyPatients in this group will be carefully observed without spraying anything 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 (4 listed)
- Patients with a history of colorectal cancer or 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 occult blood tests
Key exclusion criteria (8 listed)
- Patients with severe comorbidity
- Patients who are not suitable for colonoscopy
- Patients who received urgent or therapeutic colonoscopy
- Patients with pregnancy, inflammatory bowel disease, polyposis syndromes, suspected CRC; intestinal obstruction, coagulopathy
- Patients with aspirin, clopidogrel or other anticoagulants/ antiplatelet drugs intake within 7 days
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 |
|---|---|---|
| ChromoendoscopyPatients will undergo chromoendoscopy with spraying indigo carmine. | Procedure or surgery | Chromoendoscopy with indigo carmine solution spray |
| Conventional colonoscopyPatients will undergo conventional colonoscopy. | Procedure or surgery | Conventional colonoscopy without indigo carmine solution spray |
Primary outcome
adenoma detection rate(ADR)
Time frame: procedure time
ADR was calculated as the number of patients with at least one adenoma divided by the total number of patients. In other words, the adenoma detection rate of the sample was the proportion of patients with adenoma detected.
1 secondary outcome
detected rate of different lesions
Time frame: procedure time
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 12 Mar 2025.
- Derived from this study: PubMed 42333873Tian H, Cui C, Wang Q, Zhang R, Sun Y, Zhang M, Ji R. The Efficacy of Pan-Indigo Carmine Chromoendoscopy by Water-Jet Pump in the Detection of Colorectal Lesions: A Randomized Controlled Trial. J Gastroenterol Hepatol. 2026 Aug;41(8):2329-2337. doi: 10.1111/jgh.70504. Epub 2026 Jun 23.
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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.
Rui Ji, MD, PHD study director
Qilu Hospital of Shandong University
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 and Conventional colonoscopy 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 4 inclusion and 8 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 12 Mar 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?
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(ADR) (time frame: procedure time). 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 NCT06596317, which also lists 1 linked publication.
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 12 Mar 2025.