En-bloc resection for bladder cancer

Prospective randomised trial comparing transurethral en-bloc resection (TUEBR) with conventional transurethral resection (TURB) for bladder cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16837985

Enrollment

250

Registered

2015-09-23

Start date

2013-06-01

Completion date

Unknown

Last updated

2023-07-04

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

Conditions

Newly diagnosed bladder cancer (ICD10: C67.9) Cancer Bladder cancer

Interventions

Participants are randomly allocated into the control group or the intervention group. The intervention group will undergo transurethral en-bloc resection of the bladder tumor (TUEBR), and the control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed, suspected bladder cancer 2. Age 18 years or over 3. 1-3 bladder tumors 4. Tumor diameter between 1 and 3.5 cm

Exclusion criteria

Exclusion criteria: 1. More than 3 tumors 2. Tumors larger than 3.5 cm 3. Solid tumors 4. Tumors with a large tumor base 5. Tumors in bladder diverticula

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival (RFS). For primary endpoint (recurrence) the time from operation to biopsy date, confirming the recurrence, is measured.	—

Secondary

Measure	Time frame
1. Interobserver variability of pathological stage. The histological slides from the primary operation are sent to 5 pathologists at the end of study. The tumorstage (Ta/T1/T2/Tis) is noted and the interobserver variability between groups is measured 3, 6, 12, 18, 24, 36 months after operation. 2. Urinary cytology after resection (normal, atypic or malign) is measured 3, 6, 12, 18, 24, 36 months after operation. An additional follow up with cytology will be 4 weeks after operation	—

Measure

Time frame

1. Interobserver variability of pathological stage. The histological slides from the primary operation are sent to 5 pathologists at the end of study. The tumorstage (Ta/T1/T2/Tis) is noted and the interobserver variability between groups is measured 3, 6, 12, 18, 24, 36 months after operation. 2. Urinary cytology after resection (normal, atypic or malign) is measured 3, 6, 12, 18, 24, 36 months after operation. An additional follow up with cytology will be 4 weeks after operation

—

Countries

Sweden

Outcome results

None listed

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