Modified en bloc resection for large bladder tumors
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
This study tests a new surgical method for removing large bladder tumors to see if it helps patients have better outcomes and recover more quickly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04081246 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of a hybrid surgical technique called modified en bloc resection for patients with bladder tumors measuring 3 cm or larger. The approach involves first removing the exophytic part of the tumor in pieces, followed by en bloc resection of the tumor base to ensure complete local resection. This method aims to improve oncological control and reduce the need for additional surgeries by ensuring proper staging and complete removal of the tumor. The study will evaluate the outcomes of this technique in terms of tumor resection success and patient recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with bladder tumors that are 3 cm or larger.
Not a fit: Patients with certain comorbidities, such as significant cardiovascular disease or those undergoing aggressive treatments like radical cystectomy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could lead to better surgical outcomes and reduced recurrence rates for patients with large bladder tumors.
How similar studies have performed: While modified en bloc resection is a novel approach, similar techniques in surgical oncology have shown promise in improving outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Jeremy YC Teoh, MBBS — Chinese University of Hong Kong
- Study coordinator: Jeremy YC Teoh, MBBS
- Email: jeremyteoh@surgery.cuhk.edu.hk
- Phone: 35052625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.