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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
  • NCT 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 of resection.

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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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 between 1cm and 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: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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