En-bloc vs Conventional Resection of Primary Bladder Tumor

Bladder Cancer Clinical Trial

— eBLOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03718754
• Other study ID #: 1636/2018
• Status: Completed
• Phase: Phase 3
• Start date: February 28, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
David D'Andrea

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Residual disease within 3 months after initial TURB		3 months
Secondary	Occurrence of obturator reflex		1 day
Secondary	Operative time		1 day
Secondary	Number of participants with bladder perforation		7 days
Secondary	Upstaging of disease upon second look transurethral resection surgery		6 weeks
Secondary	Number of participants with obturator reflex		1 day
Secondary	Number of tumors with evaluable lateral and deep resection margin		4 weeks
Secondary	Number of tumors with positive lateral and deep resection margin		4 weeks
Secondary	Number of participants with conversion to other resection technique		1 day
Secondary	Number of participants with persistent disease at 2nd look TURB		6 weeks
Secondary	Recurrence-free survival		up to 5 years