Transurethral Modified En Bloc Resection For Large Bladder Tumours.

NCT04081246 | Unknown

• 1 other identifier: CREC 2018.580-T
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Bladder Neoplasm; Bladder Tumor

Keywords

Bladder cancer, bladder tumour, en bloc resection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Proper staging rate for non-muscle-invasive bladder cancer

  Seven weeks after the experimental operation

• Complete resection rate for muscle-invasive bladder cancer

  Seven weeks after the experimental operation

• Successful modified en bloc resection rate

  Immediately post-operative

• Negative circumferential resection margin rate

  One week after the experimental operation

• Negative deep resection margin rate

  One week after the experimental operation

Study Arms (1)

Modified en bloc resection

EXPERIMENTAL

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

Interventions

Bipolar transurethral modified en bloc resection of bladder tumour DEVICE

Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)

Modified en bloc resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (4)

• 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.

  PMID: 10687997 BACKGROUND

• 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.

  PMID: 20303646 BACKGROUND

• 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.

  PMID: 27324428 BACKGROUND

• 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.

  PMID: 11157016 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jeremy YC Teoh, MBBS

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy YC Teoh, MBBS

CONTACT

35052625; jeremyteoh@surgery.cuhk.edu.hk

Steven Leung

CONTACT

35051663; stevenleung@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: September 7, 2020
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)