En-bloc vs Conventional Resection of Primary Bladder Tumor

NCT03718754 | Completed Phase 3

• 1 other identifier: 1636/2018
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• The pathological staging assessment for eTURB compared to cTURB

  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

  4 weeks

Secondary Outcomes (11)

• Residual disease within 3 months after initial TURB

  3 months

• Occurrence of obturator reflex

  1 day

• Operative time

  1 day

• Number of participants with bladder perforation

  7 days

• Upstaging of disease upon second look transurethral resection surgery

  6 weeks

Study Arms (2)

En-Bloc TURB

ACTIVE COMPARATOR

Device: En-Bloc TURB

Conventional TURB

ACTIVE COMPARATOR

Device: Conventional TURB

Interventions

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.

En-Bloc TURB

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.

Conventional TURB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David D'Andrea: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• D'Andrea D, Soria F, Hurle R, Enikeev D, Kotov S, Regnier S, Xylinas E, Lusuardi L, Heidenreich A, Cai C, Frego N, Taraktin M, Ryabov M, Gontero P, Comperat E, Shariat SF; eBLOC Study Team. En Bloc Versus Conventional Resection of Primary Bladder Tumor (eBLOC): A Prospective, Multicenter, Open-label, Phase 3 Randomized Controlled Trial. Eur Urol Oncol. 2023 Oct;6(5):508-515. doi: 10.1016/j.euo.2023.07.010. Epub 2023 Aug 4.

  PMID: 37543464 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Shahrokh Shariat, M.D.

  Shahrokh.shariat@meduniwien.ac.at

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 24, 2018
• Study Start: February 28, 2019
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)