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JOURNAL ONKOLOGIE – STUDIE
eBLOC

En-bloc vs Conventional Resection of Primary Bladder Tumor

Rekrutierend

NCT-Nummer:
NCT03718754

Studienbeginn:
Februar 2019

Letztes Update:
27.06.2019

Wirkstoff:
-

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
David D'Andrea, David D'Andrea

Collaborator:
-

Studienleiter

Shahrokh Shariat, M.D.
Study Chair
Shahrokh.shariat@meduniwien.ac.at

Kontakt

Studienlocations
(1 von 1)

Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
David D'Andrea, M.D.
E-Mail: david.dandrea@meduniwien.ac.at

Francesco Soria, M.D.
E-Mail: francesco.soria@meduniwien.ac.at
» Ansprechpartner anzeigen

Studien-Informationen

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.
 

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. The pathological staging assessment for eTURB compared to cTURB (Time Frame - 4 weeks)



Secondary outcome:

1. Residual disease within 3 months after initial TURB (Time Frame - 3 months)

2. Occurrence of obturator reflex (Time Frame - 1 day)

3. Operative time (Time Frame - 1 day)

4. 30-day complications (Time Frame - 30 days)

5. Upstaging of disease upon second look transurethral resection surgery (Time Frame - 6 weeks)

Studien-Arme

  • Active Comparator: En-Bloc TURB
  • Active Comparator: Conventional TURB

Geprüfte Regime

  • En-Bloc TURB:
    En-bloc resection will be performed at each center based on local clinical practice and available instruments. Laser resection, hydrodissection with HybridKnife® or electric resection are allowed. All procedures, including cTURB, must be performed with an imaging enhancing technique (PDD / NBI at surgeon's discretion). After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.
  • Conventional TURB:
    En-bloc resection will be performed at each center based on local clinical practice and available instruments. After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.

Quelle: ClinicalTrials.gov


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