bladder cancer
Conditions
Interventions
Phase 1: Rotatable bi-channel bladder tumor en bloc resection (RBC-ERBT) :Rotatable bi-channel bladder tumor en bloc resection (RBC-ERBT)
Phase 2: Rotatable bi-channel bladder tumor en bloc resection (RBC-ERBT) :Rotatable bi-channel bladder tumor en bloc resection (RBC-ERBT)
Phase 2: ERBT:Traditional en bloc resection of bladder tumor (ERBT)
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Male or female, aged 18 or above. Diagnosed with non-muscle-invasive bladder tumor by preoperative imaging or cystoscopy. No more than 4 lesions. The maximum diameter of a single lesion does not exceed 3 cm. No contraindications to surgery found upon preoperative examination. ECOG score of less than 2. Volunteers who are willing to participate in this study, have signed the informed consent form, and are willing to accept follow-up.
Exclusion criteria
Exclusion criteria: Urethral stricture, making it impossible to introduce the ERBT or RBC-ERBT device transurethrally. Presence of other non-curative malignant tumors. Acute urinary tract infection. Concurrent severe cardiopulmonary dysfunction or coagulation disorder, with inability to tolerate anesthesia or surgery. Poor compliance, unable to cooperate with follow-up treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate;Technical success rate;Overall survival (OS);Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Detrusor Muscle Detection Rate in Specimens;Operation time;Lesion resection time;Secondary resection rate;Postoperative tumor recurrence rate at various time points, including 3 months, 1 year, 2 years, 3 years, and 5 years postoperatively;Postoperative reoperation rate, including 3 months, 1 year, 2 years, 3 years, and 5 years postoperatively;Postoperative survival rate at various time points, including 3 months, 1 year, 2 years, 3 years, and 5 years postoperatively;Incidence of bladder perforation;Incidence of obturator reflex;Incidence of bleeding;Incidence of postoperative complications;Postoperative bladder irrigation time;Duration of indwelling catheter;Postoperative hospital stay time; | — |
Countries
China
Contacts
Public ContactBoxin XUE
The Second Affiliated Hospital of Soochow University
Outcome results
None listed