Impact of Indigo Carmine Pump Spraying on the Adenoma Detection Rate

March 11, 2025 updated by: Yanqing Li, Shandong University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chromoendoscopy with indigo carmine solution spray
Patients in this group will be carefully observed with spraying indigo carmine solution during the colonoscopy withdraw.
Procedure: Chromoendoscopy
Patients will undergo chromoendoscopy with spraying indigo carmine.
Active Comparator: Conventional colonoscopy without indigo carmine solution spray
Patients in this group will be carefully observed without spraying anything during the colonoscopy withdraw.
Procedure: Conventional colonoscopy
Patients will undergo conventional colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
procedure time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detected rate of different lesions
Time Frame: procedure time
Lesions are classified according to their size, location, morphology and histopathology, the corresponding detection rate was calculated as secondary outcome measures.
procedure time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Study Director: Rui Ji, MD, PHD, Qilu Hospital, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022SDU-QILU-294

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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