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Brief Title: En-bloc vs Conventional Resection of Primary Bladder Tumor

En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial

INTRODUCTION

  • Org Study ID: 1636/2018
  • Secondary ID: N/A
  • NTC ID: NCT03718754
  • Sponsor: David D'Andrea

BRIEF SUMMARY


Based on current evidence, we hypothesize that eTURB represents an improvement in the
surgical management of NMIBC. The resection is more precise and complete compared to cTURB.
Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder
wall layers, allows an accurate pathological review which leads to correct risk allocation
and therapy.

To answer these questions, we designed a RCT comparing eTURB with cTURB. Primary outcome of
our study will be the accuracy of pathological staging assessment measured by the presence of
detrusor muscle in the specimen as a surrogate parameter for quality and completeness of
resection.

Secondary end point will be completeness of tumor removal reflected by cancer persistence
within 3 months of the resection.


  • Overall Status
    Recruiting
  • Start Date
    February 28, 2019
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: The pathological staging assessment for eTURB compared to cTURB

Primary Outcome 1 - Timeframe: 4 weeks

CONDITION

  • Bladder Cancer

ELIGIBILITY


Inclusion Criteria

Subjects must meet all the following inclusion criteria to participate in this study:

- Diagnosis by cystoscopy of primary papillary non-muscle invasive bladder urothelial
carcinoma (cTa, cT1)

- Imaging examinations shows that the bladder muscle has not been affected, no lymph
node metastasis or distant metastasis;

- Diameter of tumor <3cm

- Number of lesions ≤3 (The position of small lesions relatively concentrated as one
place)

- Patients who agree to eTURB or cTURB surgery, and will be effected to the
postoperative follow-up treatment such as conventional infusion after the operation

Exclusion Criteria

- Pure carcinoma in situ

- Contraindications to surgery (i.e. bladder fibrosis)

- Diameter of tumor >3cm

- Number of lesions >3

- Poor performance status making a surgical intervention too risky

- Life expectancy of less than one year

- Patient refused to participate

- Pregnancy

- History of upper urinary tract malignancy

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Shahrokh Shariat, M.D.

Role: Study Chair

Affiliation: Shahrokh.shariat@meduniwien.ac.at

Overall Contact

Name: Shahrokh Shariat, M.D.

Phone: 00434040026150

Email: david.dandrea@meduniwien.ac.at

LOCATION

Facility Status Contact
Facility: Medical University of Vienna
Vienna, 1090
Austria 		Status: Recruiting Contact:
David D'Andrea, M.D.

david.dandrea@meduniwien.ac.at

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