Ureteral urothelial carcinoma
Conditions
Interventions
Experimental group:Total ureterectomy combined with ileal substitution
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for clinically isolated kidney: (1)Congenital isolated kidney;(2) Acquired isolated kidney (contralateral kidney has been removed for reasons including but not limited to kidney tumor or renal pelvis ureteral tumor, kidney injury, kidney donation, etc.); (3) Solitary functional kidney refers to the condition of contralateral kidney dysfunction, including but not limited to congenital non functional kidney malformation, chronic pyelonephritis, glomerulonephritis, polycystic kidney disease, multiple kidney stones with hydronephrosis, etc. 2.The clinical diagnosis is a patient with ureteral tumor, and the pathological diagnosis of the lesion tissue biopsy or urine cytology is urothelial carcinoma. The pathological diagnosis was made within 3 months before the screening period; 3. Imaging examination and/or pathological staging T2-3; 4.Single lesion = 3cm, or (and) number of ureteral lesions >= 3; 5.I have a strong desire to protect my kidneys; 6.Age range: 18-80 years old, male or female not limited; 7.The patient's general condition is good, with an ECOG score of 1-2 points (Karnofsky score>40); 8.The patient or authorized representative understands and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Preoperative imaging suggests peripheral organ invasion, pelvic or abdominal wall involvement, or lymph node metastasis (N1) and distant metastasis (M1) stage; 2.Preoperative imaging or endoscopic examination suggests the presence of urothelial carcinoma lesions in the renal pelvis and calyx cavity, and complete resection of the upper urinary tract tumor cannot be achieved with simple total ureteral resection; 3.Previous intestinal diseases, abdominal surgery history, etc. make it impossible to perform ileal ureteral replacement surgery; 4.The patient has received infusion chemotherapy, systemic chemotherapy, or immunotherapy in the 6 months prior to enrollment; 5. Accompanied by bacteremia, toxemia and other serious infectious diseases; 6.Preoperative renal dysfunction with decompensation (glomerular filtration rate2.5 times the upper limit of normal or total bilirubin>1.5 times the upper limit of normal); 9.Suffering from other malignant tumors with a treatment period of less than two years (excluding a personal history of urothelial carcinoma); 10.Pregnant or lactating women; 11.Complications such as severe urethral stricture and ureteral stricture that cannot tolerate ureteroscopy surgery; 12. Participants in other clinical trials during the same period; 13. Researchers believe that there are other situations that are not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year, 2-year, and 5-year recurrence free survival (RFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year, 2-year, and 5-year overall survival (OS);1-year, 2-year, and 5-year intravesical recurrence-free survival (IVRFS);Incidence of postoperative adverse events;Quality-adjusted life years, QALYs; | — |
Countries
China
Contacts
Public ContactJiang Haowen
Huashan Hospital, Fudan University
Outcome results
None listed