NMIBC
Conditions
Interventions
Experimental group:The included subjects were injected with loplatin (50mg/50ml normal saline, once a week, twice in total) into the bladder.
Sponsors
Tongji Hospital, Tongji Medical College of hust
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a) Patients with bladder tumors who are suitable for transurethral resection of bladder tumors; b) Patients with no urinary tract malformations; c) Imaging examination (including B-ultrasound, CT, MRI or PET-CT, etc.) showed no evidence of extracellular bladder invasion, lymph node metastasis or other organ metastasis; d) Preoperative magnetic resonance evaluation showed no muscular infiltration in patients (i.e., patients with 1-3 VI-RADS); e) Patients with multiple tumors (=8) or pedicled tumors with large tumor diameter (maximum diameter of a single tumor =3cm) or wide-base tumors with large tumor diameter (maximum diameter of a single tumor =3cm) who were determined by the investigators to be difficult to complete surgery by TmLRBT; f) First surgery or last intravesical surgery > 1 year; g) Subjects voluntarily participate in this experiment and have signed informed consent; h) Age 18-75 years old, regardless of gender. Having full capacity for civil conduct;
Exclusion criteria
Exclusion criteria: a) Patients with serious heart, lung, liver, kidney, blood and other underlying diseases that cannot tolerate general anesthesia or surgery; b) Patients who are unable to receive standard treatment or follow-up; c) Pregnant or lactating women and women of reproductive age who refuse to use contraception during the treatment observation period; d) Persons addicted to drug or alcohol abuse, with personality or mental disorders, without or with limited capacity for civil conduct; e) Patients with contraindications related to loplatin use; f) Patients who participated in other clinical trials within 1 month of the perioperative period; g) Those that the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder-preserving treatment rate;Treatment-related adverse reactions;Dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation delay time;Mean operating time;Incidence of obturator nerve reflex and bladder perforation;Postoperative continuous lavage time and postoperative catheter indwelling time; | — |
Countries
China
Contacts
Public ContactZheng Liu
Tongji Hospital, Tongji Medical College of hust
Outcome results
None listed