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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0005253

Enrollment

Registered

2020-07-23

Start date

2020-09-16

Completion date

Unknown

Last updated

2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1. WLE-Fluorescence Group ? Insert colonoscopy with a transparent distal attachment under white light endoscopy (WLE). ? Intravenous administration of fluorescein sodium 1 ampule (10%, 5 mL) af

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Number of fluorescence positive polyps	—

Secondary

Measure	Time frame
Ratio of patients having additionally detected lesions: A vs. B;Ratio of segments having additionally detected lesions: a vs. b;Withdrawal time	—

Countries

Korea, Republic of

Contacts

Public ContactYunJeong In

Asan Medical Center

yjin@amc.seoul.kr+82-2-3010-7398

Outcome results