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The randomized controlled study for intravesical instillation of Pseudomonas aeruginosa and gemcitabine in the prevention of postoperative recurrence of non-muscle invasive bladder cancer

The randomized controlled study for intravesical instillation of Pseudomonas aeruginosa and gemcitabine in the prevention of postoperative recurrence of non-muscle invasive bladder cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026643
Enrollment
Unknown
Registered
2019-10-17
Start date
2019-11-20
Completion date
Unknown
Last updated
2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-muscle invasive bladder cancer

Interventions

Gemcitabine group:Intravesical instillation of gemcitabine chemotherapy after bladder tumor surgery
Pseudomonas aeruginosa group:Intravesical instillation of Pseudomonas aeruginosa injection after bladder tumor operation

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients and his families who volunteered to participate this study. And Patient is informed and has given written informed consent. 2. 18 years of age and less than 75 years of age, both men and women; 3. Patients undergoing transurethral resection of bladder tumors; 4. Preoperative diagnosis is non-muscle invasive bladder cancer (Ta-T1N0M0), pathological diagnosis of urothelial carcinoma; 5. no previous history of other malignant tumors.

Exclusion criteria

Exclusion criteria: 1. The tumor has been invading the ureter, prostate and urethra; 2. Do not have capable or behavioral capacity is limited; 3. Preoperative routine chest X-ray and pelvic enhancement CT examination revealed that distant metastasis or intraoperative findings of tumor invasive muscle layer. 4. Have other serious diseases, including cardiovascular, respiratory, kidney, or liver diseases, and combine to control patients with poor hypertension and diabetes; 5. Pregnant and lactating women; 6. History of pelvic surgery or lower urinary tract surgery; 7. Preoperative history of chemotherapy; 8. Severe coagulation function abnormal electrolyte balance disorder hypoproteinemia was corrected without obvious improvement; 9. Have narcotic contraindications for the anaphylaxis of narcotic drugs; 10. The researcher considers that there are any other circumstances that are not suitable for participating in the test.

Design outcomes

Primary

MeasureTime frame
Postoperative recurrence rate;

Countries

China

Contacts

Public ContactShang Panfeng
shangpf@lzu.edu.cn+86 13919785295

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026