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Observational research for the efficacy of En-bloc resection and conventional transurethral resection of bladder tumor combined with secondary resection for NMIBC: an open randomized, controlled trial

Observational research for the efficacy of En-bloc resection and conventional transurethral resection of bladder tumor combined with secondary resection for NMIBC: an open randomized, controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027839
Enrollment
Unknown
Registered
2019-11-30
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

bladder cancer

Interventions

Treatment group:en bloc transurethral resection
Control group:conventional TURBT + secondary transurethral resection

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years old, Male or female; 2. All cases were pathologically diagnosed with non-muscle-invasive urothelial carcinoma and without other components (eg: adenocarcinoma, squamous cell carcinoma, sarcoma); 3. All patients undergo standard TURBT or en bloc transurethral resection by senior physicians and receive routine intravesical instillation; (BCG); 4. Tumor number <= 3, tumor size <= 3cm; 5. Pathologically diagnosed as non muscular invasive bladder urothelial carcinoma which is defined as Moderate or High risk; 6. Patient is able to understand the trail, sign the informed consent and are willing to get regular follow-up.

Exclusion criteria

Exclusion criteria: 1. Lymph node or distant metastasis; 2. Tumor grade and stage can not be accurately assessed; 3. Visible tumor were not completely removed at the first TURBT due to tumor location, tumor number, carcinoma in situ, obturator nerve reflex and other reasons; 4. The confirmed or suspected bladder perforation; 5. The clinical data is incomplete; 6. Combined with other serious diseases and life expectancy <2 years; 7. Pregnancy or lactating women; 8. Can not understand the content of the trail and sign the informed consent; 9. With upper urinary tract urothelial carcinoma, low-risk bladder urothelial carcinoma.

Design outcomes

Primary

MeasureTime frame
Recurrence rate;

Secondary

MeasureTime frame
Progression rate;Survival rate;

Countries

China

Contacts

Public ContactHu Hailong

The Second Hospital of Tianjin Medical University

hhllove2004@163.com+86 13662096232

Outcome results

None listed

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