Clinical trial NCT03718754: En-bloc vs Conventional Resection of Primary Bladder Tumor
Official title: En-bloc vs Conventional Resection of Primary Bladder Tumor: Prospective Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bladder Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 384
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The pathological staging assessment for eTURB compared to cTURB
timeFrame: 4 weeks
Secondary outcomes:
measure: Residual disease within 3 months after initial TURB
timeFrame: 3 months
measure: Occurrence of obturator reflex
timeFrame: 1 day
measure: Operative time
timeFrame: 1 day
measure: Number of participants with bladder perforation
timeFrame: 7 days
measure: Upstaging of disease upon second look transurethral resection surgery
timeFrame: 6 weeks
measure: Number of participants with obturator reflex
timeFrame: 1 day
measure: Number of tumors with evaluable lateral and deep resection margin
timeFrame: 4 weeks
measure: Number of tumors with positive lateral and deep resection margin
timeFrame: 4 weeks
measure: Number of participants with conversion to other resection technique
timeFrame: 1 day
measure: Number of participants with persistent disease at 2nd look TURB
timeFrame: 6 weeks
measure: Recurrence-free survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Shahrokh.shariat@meduniwien.ac.at
name: Shahrokh Shariat, M.D.
role: STUDY_CHAIR
References: