Fluorescence ureteroscopy-assisted transurethral surgery with oral 5-aminolevulinic acid for upper urinary tract tumor

Phase 2

Recruiting

• Conditions: ocalized upper urinary tract cancer (renal pelvic cancer and ureteral cancer); Urothelial carcinoma, Upper urinary tract cancer, renal pelvic cancer, ureteral cancer; 0210 (ICD code C65, C66)

• Registration Number: JPRN-jRCTs051210042
• Lead Sponsor: Miyake Makito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) Patients with clinical Ta-1N0M0 localized upper urinary tract cancer desire kidney-preservation therapy and meet any of the following A to E.
A. Tumor develops in patients with solitary kidney or tumor develops bilaterally.
B. Patients with chronic kidney disease are expected to avoid renal replacement therapy in the future by
kidney-preservation therapy.
C. Due to poor performance status, it is clinically judged that total nephroureterectomy is not indicated.
D. Patients have a single tumor with a major axis of 10 mm or less and have a healthy kidney on the
contralateral side.
E. Patients desire kidney-preservation therapy although they are recommended radical
nephroureterectomy.
2) Age, 20 years or older (Regardless of gender)
3) The pathological diagnosis is confirmed by ureteroscopic biopsy or urine cytology.
4) The name and condition of the disease have been announced to the patient, and he / she must be given an explanation when participating in this study. The written consent at his / her will must be obtained with
sufficient understanding.
5) Bone marrow function and organ function (excluding renal function) are sufficient within 60 days before
registration.

Exclusion Criteria

1) Patients with a history of allergic reaction to 5-aminolevulinic acid.
2) Pregnant women, lactating women and patients who may be pregnant.
3) Cases with liver dysfunction and inflammatory disease.
4) Patients with porphyria or patients with a history of allergic reaction to porphyrin-related substances.
5) Cases in which you cannot consent or take the medicine on your own initiative.
6) Inappropriate for the enrolment by the judgement of the physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified