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OpenTrials
Completed

NCT Number: NCT03718754

En-bloc vs Conventional Resection of Primary Bladder Tumor

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

En-Bloc TURB

Device

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

Device

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.

Primary outcomes

  1. The pathological staging assessment for eTURB compared to cTURB

    Time frame: 4 weeks

    The primary objective of the study is to assess whether eBLOC is associated with a higher rate of detrusor muscle in the pathologic specimen, compared to cTURB

Secondary outcomes

  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. Number of participants with bladder perforation

    Time frame: 7 days

  5. Upstaging of disease upon second look transurethral resection surgery

    Time frame: 6 weeks

  6. Number of participants with obturator reflex

    Time frame: 1 day

  7. Number of tumors with evaluable lateral and deep resection margin

    Time frame: 4 weeks

  8. Number of tumors with positive lateral and deep resection margin

    Time frame: 4 weeks

  9. Number of participants with conversion to other resection technique

    Time frame: 1 day

  10. Number of participants with persistent disease at 2nd look TURB

    Time frame: 6 weeks

  11. Recurrence-free survival

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

David D'Andrea

Other

Registry information

Official study title

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

Acronym: eBLOC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 24, 2018
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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