Effectiveness of Fluorescein-based Multispectral Smart Endoscopy for Detecting Colorectal Neoplasia

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0005253
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-29
• Last Update Posted: 24 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

?Male or female patients who were referred for colonoscopic polypectomy
?Age from 30 to 79 years
?Patients who agreed to participation of this study

Exclusion Criteria

? Previous history of hypersensitivity or allergic reaction on contrast dye including fluorescein sodium and other radiocontrast dye
?Previous history of severe allergic reaction including anaphylaxis and anaphylactoid reaction, regardless of (is) cause
?Documented thrombocytopenia (platelet count <80,000/uL) within 6 months of the scheduled colonoscopic polypectomy
?Prolonged prothrombin time (=1.7 INR) within 6 months of the scheduled colonoscopic polypectomy
?Prolonged activated partial thrombin time (=35 seconds) within 6 months of the scheduled colonoscopic polypectomy
?Positive pregnancy test (urine beta-hCG) in a premenopausal female or <12 months of amenorrhea period in menopausal females
?A nursing (breast-feeding) female
?Non-ambulatory persons due to neurologic sequelae due to cerebral or neurological disorder
?Non-ambulatory persons due to general weakness
?Severe asthma, emphysema, heart failure, or respiratory infection causing respiratory distress
?Active liver disease patients showing elevated liver enzymes (AST or ALT) over twice of upper normal limit within 6 months of the scheduled polypectomy
?Serum creatinine = 1.4 mg/dL or estimated GFR < 30 ml/min/1.73m2
?Resting systolic blood pressure =180 mmHg or diastolic blood pressure =120 mmHg
?Patients who did not agree to study participation

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of fluorescence positive polyps

Secondary Outcome Measures

Name	Time	Method
Ratio of patients having additionally detected lesions: A vs. B;Ratio of segments having additionally detected lesions: a vs. b;Withdrawal time