Clinical trial NCT04081246: Transurethral Modified En Bloc Resection For Large Bladder Tumours.
Official title: Transurethral Modified En Bloc Resection For Large Bladder Tumours.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Bladder Neoplasm
Bladder Tumor
Keywords: Bladder cancer, bladder tumour, en bloc resection
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Modified en bloc resection is a hybrid technique involving piecemeal resection of the exophytic part of the bladder tumour, followed by en bloc resection of the tumour base. In this study, we shall investigate the efficacy of modified en bloc resection for patients with bladder tumours of ≥3cm in size.

Detailed description: The biggest limiting factor of en bloc resection is the size of the bladder tumour. Resection of the bladder tumour is technically feasible, but the retrieval of specimen in one piece is restricted by the narrow size of the urethra. However, the greatest advantage of en bloc resection is to ensure complete local resection rather than the theoretical benefit of avoiding tumour re-implantation. Therefore, the concept of modified en bloc resection for large bladder tumours of ≥3cm has evolved. It is a hybrid technique involving piecemeal resection of the exophytic part of the bladder tumour, followed by en bloc resection of the tumour base. By resecting the exophytic part of the bladder tumour, the size of main tumour bulk can be reduced. By performing en bloc resection of the tumour base, the advantage of ensuring complete tumour resection beneath the submucosal plane can be preserved, and the tumour base specimen remains intact for histological assessment of the resection margins. Modified en bloc resection is a promising surgical technique which can potentially ensure complete tumour resection, reduce the need of second-look transurethral resection, and improve the oncological control of non-muscle-invasive bladder cancer in long run. It may also ensure proper staging of muscle-invasive bladder cancer at the first surgery, thus avoiding the need of second-look transurethral resection in under-staged patients.

In this study, we shall evaluate the efficacy of modified en bloc resection for patients with bladder tumours of ≥3cm. All patients will have MRI before modified en bloc resection. All patients with non-muscle-invasive bladder cancer will be offered second-look transurethral resection in 2-6 weeks' time. All patients with muscle-invasive bladder cancer but not distant metastasis will be offered radical cystectomy, pelvic lymphadenectomy and urinary diversion; for those who refuse or who are considered unfit for radical surgery, second-look transurethral resection will be offered. All patients will have a second MRI before the second surgery. The modified en bloc resection specimen results will be compared with the final pathology results in the second surgery. The presence of any residual or upstaging of disease will be determined. The results of the two sets of MRI will also be compared with the final pathology results. The accuracy of MRI in the evaluation of bladder cancer will be determined.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80 years old with informed consent
* Bladder tumours with maximal dimension of ≥ 3cm

Exclusion Criteria:

* Bladder tumour detected during intravesical Bacillus Calmette-Guerin therapy (These patients warrant more aggressive treatment, i.e. radical cystectomy)
* Estimated glomerular filtration rate of \<60mL/min.
* Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block)
* Presence of GOLD Stage III or IV chronic obstructive pulmonary disease
* History of bleeding disorder or use of anti-coagulant
* Presence of other active malignancy
* ECOG performance status ≥ 2 (Ambulatory and capable of all self care but unable to carry our any work activities. Confined to bed or chair less than 50% of waking hours)
* Pregnancy
* Presence of metallic foreign body or implant which is not MRI compatible
* Known history of claustrophobia

Primary outcomes:
measure: Composite outcome on the rate of complete resection for non-muscle-invasive bladder cancer and proper staging for muscle-invasive bladder cancer
timeFrame: Seven weeks after the experimental operation
Secondary outcomes:
measure: Proper staging rate for non-muscle-invasive bladder cancer
timeFrame: Seven weeks after the experimental operation
measure: Complete resection rate for muscle-invasive bladder cancer
timeFrame: Seven weeks after the experimental operation
measure: Successful modified en bloc resection rate
timeFrame: Immediately post-operative
measure: Negative circumferential resection margin rate
timeFrame: One week after the experimental operation
measure: Negative deep resection margin rate
timeFrame: One week after the experimental operation
measure: Detrusor muscle sampling rate
timeFrame: One week after the experimental operation
measure: Occurrence of obturator reflex
timeFrame: Intra-operative
measure: Operative time
timeFrame: Immediately post-operative
measure: Rate of mitomycin C instillation
timeFrame: Immediately post-operative
measure: Duration of bladder irrigation
timeFrame: Three days after the experimental operation.
measure: Duration of urethral catheterisation
timeFrame: Three days after the experimental operation
measure: Hospital stay
timeFrame: Three days after the experimental operation
measure: 30-day complications
timeFrame: Thirty days after the experimental surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Jeremy YC Teoh, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Divrik RT, Sahin AF, Yildirim U, Altok M, Zorlu F. Impact of routine second transurethral resection on the long-term outcome of patients with newly diagnosed pT1 urothelial carcinoma with respect to recurrence, progression rate, and disease-specific survival: a prospective randomised clinical trial. Eur Urol. 2010 Aug;58(2):185-90. doi: 10.1016/j.eururo.2010.03.007. Epub 2010 Mar 19.
citation: Babjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17.
citation: Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75. doi: 10.1200/JCO.2001.19.3.666.