Clinical Scorecard: Evaluating the Efficacy of Indigo Carmine Chromoendoscopy in Identifying Gastric Cancer and Adenomas During Upper GI Endoscopy: A Protocol for a Prospective Multicenter Observational Study (INDIGO Study)

At a Glance

Key Highlights

• Indigo carmine has been used in Japan since the 1970s for upper gastrointestinal endoscopy.
• The study aims to evaluate the effectiveness of indigo carmine in detecting gastric neoplasia.
• A total of 1050 patients will be enrolled across over 30 institutions.
• The primary endpoint is the detection rate of gastric cancer or adenoma during second-pass observation.
• The study is designed to achieve 80% power with a predefined detection rate threshold.

Guideline-Based Recommendations

Diagnosis

• Use indigo carmine chromoendoscopy for enhanced detection of gastric cancer and adenomas.

Management

• Conduct upper gastrointestinal endoscopy for patients with a history of gastric cancer or adenoma.

Monitoring & Follow-up

• Monitor patients for signs of gastric cancer or adenoma post-endoscopic treatment.

Risks

• Exclude patients with severe coagulation disorders or those for whom biopsy is not feasible.

Patient & Prescribing Data

Patients undergoing surveillance after endoscopic treatment or pretreatment screening.

Indigo carmine may improve detection rates of early gastric neoplasia.

Clinical Best Practices

• Obtain written informed consent prior to patient registration.
• Follow STROBE guidelines for reporting observational studies.
• Ensure eligibility criteria are met before patient enrollment.

Related Resources & Content

• INDIGO Study Registration