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Effect of continuous postoperative bladder lavage for upper urothelial carcinoma on prevention of intravesical recurrence. (BLUC Study)

BLUC Study (BLUC Study)

Inoue Takahiro

Mie University Hospital

2-174 Edobashi, Tsu, Mie

tinoue28@med.mie-u.ac.jp

Owa Shunsuke

Mie University Hospital

2-174 Edobashi, Tsu, Mie

+81-59-232-1111

yamato4314@med.mie-u.ac.jp

Recruiting

May. 19, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

prevention purpose

1) Disease name Upper urothelial carcinoma (cancer of the renal pelvis and ureter) Stage 0a-3 (cTa-T3), cN0, cM0
2) Age. 18 to 80 years old
3) Performance Status (ECOG). 0 to 1
4) Patients with written consent to participate in the study

1) Those who have a history of treatment for bladder cancer prior to radical nephrectomy for UTUC
2) Those who have a history of treatment for UTUC in the past
3) Those who have metastatic lesions (lymph nodes, other organs, etc.) at the time of diagnosis
4) Those who have a history of radiation therapy
5) Those who are pregnant or may be pregnant, or are breastfeeding
6) Those who are judged by the principal investigator or sub-investigator to be unsuitable as research subjects

Both

Upper urothelial carcinoma (renal pelvis and ureter)

Group A: No continuous bladder lavage
Group B: Group that performs continuous bladder lavage

Ureteral cancer, renal pelvis cancer

bladder lavage

C04.588.945.947.940, C04.588.699

The primary endpoint will be the duration of recurrence-free period in the bladder during the 108-week observation period from the date of surgery.
The bladder recurrence-free period is defined as the period from the date of surgery to the date of confirmation of recurrence by cystoscopy. In cases with no follow-up, the period is terminated on the last day of confirmed recurrence-free period before the loss of follow-up.

However, for cases without 108-week follow-up, data on the presence or absence of recurrence at the last observation will be used. Deaths without intracisternal recurrence within 108 weeks shall be treated as no intracisternal recurrence.

The secondary endpoints will be the bladder recurrence-free rate, overall survival, recurrence-free survival, adverse events associated with continuous bladder lavage, and factors related to bladder recurrence during the 108-week observation period from the date of surgery.

+81-59-231-5045

Jan. 27, 2025

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