Background and Purpose: In this study, we evaluated the effectiveness and safety of photodynamic diagnosis (PDD) of upper urinary tract carcinoma (UTUC) using oral 5-aminolevulinic acid (5-ALA). Materials and Methods: Consecutive adult patients with suspected UTUC based on imaging and urine cytology findings were prospectively enrolled from May 2018 to January 2019. 5-ALA (20 mg/kg) was orally administered 2 to 3 hours before diagnostic ureteroscopy (URS). Sixty-three biopsy samples were collected from 20 eligible patients using white light (WL) and PDD-URS. The primary endpoint was sensitivity, and the secondary endpoints were specificity, positive predictive value (PPV) and negative predictive value (NPV), diagnostic accuracy, and safety. Results: The sensitivity of photodynamic URS was significantly higher than that of WL-URS (93.8% vs 62.5%, p = 0.0025). Although the specificity and PPV were not different between the two procedures, PDD-URS showed a significantly higher NPV (92.3% vs 69.2%, p = 0.027) and accuracy (0.86 vs 0.75, p = 0.0297) than WL-URS. With respect to safety, no grade ≥3 adverse events related to 5-ALA administration occurred in any patients. Conclusion: We found that PDD-URS with oral 5-ALA is a safe and superior diagnostic tool for detection of UTUC compared with conventional WL-URS.
Background and Purpose: In this study, we evaluated the effectiveness and safety of photodynamic diagnosis (PDD) of upper urinary tract carcinoma (UTUC) using oral 5-aminolevulinic acid (5-ALA). Materials and Methods: Consecutive adult patients with suspected UTUC based on imaging and urine cytology findings were prospectively enrolled from May 2018 to January 2019. 5-ALA (20 mg/kg) was orally administered 2 to 3 hours before diagnostic ureteroscopy (URS). Sixty-three biopsy samples were collected from 20 eligible patients using white light (WL) and PDD-URS. The primary endpoint was sensitivity, and the secondary endpoints were specificity, positive predictive value (PPV) and negative predictive value (NPV), diagnostic accuracy, and safety. Results: The sensitivity of photodynamic URS was significantly higher than that of WL-URS (93.8% vs 62.5%, p = 0.0025). Although the specificity and PPV were not different between the two procedures, PDD-URS showed a significantly higher NPV (92.3% vs 69.2%, p = 0.027) and accuracy (0.86 vs 0.75, p = 0.0297) than WL-URS. With respect to safety, no grade ≥3 adverse events related to 5-ALA administration occurred in any patients. Conclusion: We found that PDD-URS with oral 5-ALA is a safe and superior diagnostic tool for detection of UTUC compared with conventional WL-URS.