Transurethral Modified En Bloc Resection For Large Bladder Tumours.

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Bladder Tumor; Bladder Neoplasm
• Intervention / Treatment: Device: Bipolar transurethral modified en bloc resection of bladder tumour

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy YC Teoh, MBBS; Phone Number: 35052625; Email: jeremyteoh@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Steven Leung; Phone Number: 35051663; Email: stevenleung@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Jeremy YC Teoh, MBBS; Phone Number: 35052625; Email: jeremyteoh@surgery.cuhk.edu.hk
    • Contact: Steven Leung; Phone Number: 35051663; Email: stevenleung@surgery.cuhk.edu.hk
    • Sub-Investigator: Joseph KM Li
    • Sub-Investigator: Carmen Cho
    • Sub-Investigator: Winnie Chu
    • Sub-Investigator: Ka-Lun Lo
    • Sub-Investigator: Peter KF Chiu
    • Sub-Investigator: Chi-Hang Yee
    • Sub-Investigator: Samson Chan
    • Sub-Investigator: Ho-Man Tam
    • Sub-Investigator: Hon-Ming Wong
    • Sub-Investigator: Chi-Fai Ng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified en bloc resection; For patients undergoing modified en bloc resection, piecemeal resection of the exophytic part of the bladder tumour will be performed, followed by en bloc resection of the tumour base.	Device: Bipolar transurethral modified en bloc resection of bladder tumour; Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome on the rate of complete resection for non-muscle-invasive bladder cancer and proper staging for muscle-invasive bladder cancer	Complete resection for non-muscle-invasive bladder cancer is defined as the absence of any malignancy upon second-look transurethral resection surgery, in patients who have non-muscle-invasive bladder cancer upon the first modified en bloc resection. Proper staging for muscle-invasive bladder cancer is defined as the detection of muscle-invasive bladder cancer upon the first modified en bloc resection, in all patients who have a definitive histological diagnosis of muscle-invasive bladder cancer upon modified en bloc resection or second-look transurethral resection surgery. Second look transurethral resection surgery is expected to perform within six weeks after the experimental operation and one more week is allowed for histological assessment of the second look transurethral resection specimen.	Seven weeks after the experimental operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Duration of operation	Immediately post-operative
Proper staging rate for non-muscle-invasive bladder cancer	The proper staging rate for non-muscle-invasive bladder cancer is defined as the absence of any upstaging of the T-stage upon second-look transurethral resection surgery, in patients who have non-muscle-invasive bladder cancer upon the first modified en bloc resection. Second look transurethral resection surgery is expected to perform within six weeks after the experimental operation and one more week is allowed for histological assessment of the second look transurethral resection specimen.	Seven weeks after the experimental operation
Complete resection rate for muscle-invasive bladder cancer	The complete resection rate for muscle-invasive bladder cancer is defined as the absence of any malignancy upon second-look transurethral resection surgery or radical surgery, in patients who have muscle-invasive bladder cancer upon the first modified en bloc resection. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the experimental operation and one more week is allowed for histological assessment of the second look transurethral resection specimen.	Seven weeks after the experimental operation
Successful modified en bloc resection rate	Techical success rate of modified en bloc resection	Immediately post-operative
Negative circumferential resection margin rate	Rate of negative circumferential resection margin of the modified en bloc resection pathological specimen	One week after the experimental operation
Negative deep resection margin rate	Rate of negative deep resection margin of the modified en bloc resection pathological specimen	One week after the experimental operation
Detrusor muscle sampling rate	Rate of presence of detrusor muscle in the modified en bloc resection pathological specimen	One week after the experimental operation
Occurrence of obturator reflex	Number of participants with obturator reflex encountered by the operating surgeon during the modified en bloc resection operation	Intra-operative
Rate of mitomycin C instillation	One day after the experimental operation	Immediately post-operative
Duration of bladder irrigation	Duration of bladder irrigation. Patients undergoing transurethral resection surgery have an average hospital stay of three days. Bladder irrigation is always stopped before the patient is discharged	Three days after the experimental operation.
Duration of urethral catheterisation	Duration of urethral catheterisation. Patients undergoing transurethral resection surgery have an average hospital stay of three days. Urethral catheter is often removed before the patient is discharged	Three days after the experimental operation
Hospital stay	Patients undergoing transurethral resection surgery have an average hospital stay of three days.	Three days after the experimental operation
30-day complications	Complications which occur within 30 days after the operation	Thirty days after the experimental surgery

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Jeremy YC Teoh, MBBS, Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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.
• 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.
• Ukai R, Kawashita E, Ikeda H. A new technique for transurethral resection of superficial bladder tumor in 1 piece. J Urol. 2000 Mar;163(3):878-9.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Bladder cancer, bladder tumour, en bloc resection
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CREC 2018.580-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No