Impact of Indigo Carmine Pump Spraying on the Adenoma Detection Rate

NCT06596317 | Completed

• 1 other identifier: 2022SDU-QILU-294
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  procedure time

Secondary Outcomes (1)

• detected rate of different lesions

  procedure time

Study Arms (2)

Chromoendoscopy with indigo carmine solution spray

EXPERIMENTAL

Patients in this group will be carefully observed with spraying indigo carmine solution during the colonoscopy withdraw.

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.

Procedure: Conventional colonoscopy

Interventions

Chromoendoscopy PROCEDURE

Patients will undergo chromoendoscopy with spraying indigo carmine.

Chromoendoscopy with indigo carmine solution spray

Conventional colonoscopy PROCEDURE

Patients will undergo conventional colonoscopy.

Conventional colonoscopy without indigo carmine solution spray

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Colonic Polyps; Adenomatous Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rui Ji, MD, PHD

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: September 19, 2024
• Study Start: January 11, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CN (1)