Transurethral Modified En Bloc Resection For Large Bladder Tumours.
Primary Purpose
Bladder Cancer, Bladder Neoplasm, Bladder Tumor
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Bipolar transurethral modified en bloc resection of bladder tumour
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder cancer, bladder tumour, en bloc resection
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
Sites / Locations
- Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Modified en bloc resection
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Successful modified en bloc resection rate
Techical success rate of modified en bloc resection
Negative circumferential resection margin rate
Rate of negative circumferential resection margin of the modified en bloc resection pathological specimen
Negative deep resection margin rate
Rate of negative deep resection margin of the modified en bloc resection pathological specimen
Detrusor muscle sampling rate
Rate of presence of detrusor muscle in the modified en bloc resection pathological specimen
Occurrence of obturator reflex
Number of participants with obturator reflex encountered by the operating surgeon during the modified en bloc resection operation
Operative time
Duration of operation
Rate of mitomycin C instillation
One day after the experimental operation
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
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
Hospital stay
Patients undergoing transurethral resection surgery have an average hospital stay of three days.
30-day complications
Complications which occur within 30 days after the operation
Full Information
NCT ID
NCT04081246
First Posted
September 5, 2019
Last Updated
June 24, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04081246
Brief Title
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
Official Title
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Bladder Neoplasm, Bladder Tumor
Keywords
Bladder cancer, bladder tumour, en bloc resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modified en bloc resection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bipolar transurethral modified en bloc resection of bladder tumour
Intervention Description
Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)
Primary Outcome Measure Information:
Title
Composite outcome on the rate of complete resection for non-muscle-invasive bladder cancer and proper staging for muscle-invasive bladder cancer
Description
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.
Time Frame
Seven weeks after the experimental operation
Secondary Outcome Measure Information:
Title
Proper staging rate for non-muscle-invasive bladder cancer
Description
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.
Time Frame
Seven weeks after the experimental operation
Title
Complete resection rate for muscle-invasive bladder cancer
Description
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.
Time Frame
Seven weeks after the experimental operation
Title
Successful modified en bloc resection rate
Description
Techical success rate of modified en bloc resection
Time Frame
Immediately post-operative
Title
Negative circumferential resection margin rate
Description
Rate of negative circumferential resection margin of the modified en bloc resection pathological specimen
Time Frame
One week after the experimental operation
Title
Negative deep resection margin rate
Description
Rate of negative deep resection margin of the modified en bloc resection pathological specimen
Time Frame
One week after the experimental operation
Title
Detrusor muscle sampling rate
Description
Rate of presence of detrusor muscle in the modified en bloc resection pathological specimen
Time Frame
One week after the experimental operation
Title
Occurrence of obturator reflex
Description
Number of participants with obturator reflex encountered by the operating surgeon during the modified en bloc resection operation
Time Frame
Intra-operative
Title
Operative time
Description
Duration of operation
Time Frame
Immediately post-operative
Title
Rate of mitomycin C instillation
Description
One day after the experimental operation
Time Frame
Immediately post-operative
Title
Duration of bladder irrigation
Description
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
Time Frame
Three days after the experimental operation.
Title
Duration of urethral catheterisation
Description
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
Time Frame
Three days after the experimental operation
Title
Hospital stay
Description
Patients undergoing transurethral resection surgery have an average hospital stay of three days.
Time Frame
Three days after the experimental operation
Title
30-day complications
Description
Complications which occur within 30 days after the operation
Time Frame
Thirty days after the experimental surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy YC Teoh, MBBS
Phone
35052625
Email
jeremyteoh@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Leung
Phone
35051663
Email
stevenleung@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy YC Teoh, MBBS
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy YC Teoh, MBBS
Phone
35052625
Email
jeremyteoh@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Steven Leung
Phone
35051663
Email
stevenleung@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Joseph KM Li
First Name & Middle Initial & Last Name & Degree
Carmen Cho
First Name & Middle Initial & Last Name & Degree
Winnie Chu
First Name & Middle Initial & Last Name & Degree
Ka-Lun Lo
First Name & Middle Initial & Last Name & Degree
Peter KF Chiu
First Name & Middle Initial & Last Name & Degree
Chi-Hang Yee
First Name & Middle Initial & Last Name & Degree
Samson Chan
First Name & Middle Initial & Last Name & Degree
Ho-Man Tam
First Name & Middle Initial & Last Name & Degree
Hon-Ming Wong
First Name & Middle Initial & Last Name & Degree
Chi-Fai Ng
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10687997
Citation
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.
Results Reference
background
PubMed Identifier
20303646
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.
Results Reference
background
PubMed Identifier
27324428
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.
Results Reference
background
PubMed Identifier
11157016
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.
Results Reference
background
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Transurethral Modified En Bloc Resection For Large Bladder Tumours.
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