E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The trial will evaluate the efficacy and safety of TachoSil in patients undergoing cystectomy for bladder cancer and non-malignant bladder disease. TachoSil will be applied to the anastomoses between the ureters and the new bladder made of an isolated intestinal loop. The purpose of applying TachoSil to the anastomoses is to evaluate whether this treatment will reduce the degree of stenosis in the anastomoses and thus reduce the degree of impairment on the renal function. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005003 |
E.1.2 | Term | Bladder cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this trial is to evaluate the efficacy and safety of the medicinal product TachoSil® to reduce the degree of stenosis of the ureteres in patients undergoing radical cystectomy for bladder cancer and non-malignant conditions. As TachoSil® is not registered for this use, a pilot study is chosen as an initial evaluation of the use in urological surgery.
The primary measurement will be assessment of kidney function at follow up relative to kidney function at inclusion. Kidney function will be evaluated by means of intravenous renography and GFR (glomerular filtration rate). A reduction in kidney function of 10% in one side measured by renography will be regarded as indicative of ureteral stenosis and a reduction of GFR 25% will indicate bilateral reduction/stenosis. . The kidney function will be assessed by intravenous renography and Glomerular Filtration Rate (GRF) at follow up after 2-3 months and 1 year after discharge. |
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E.2.2 | Secondary objectives of the trial |
Secondary end points Number of patients undergoing re-operation. Number of patients receiving stent following surgery.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Has the subject given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the subject. Is the subject 18 years of age or older ? Is the patient scheduled for elective cystectomy for any reason? Normal renal function by renography
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E.4 | Principal exclusion criteria |
Patients who have previously undergone any surgery on the bladder Previous radiation therapy Previous chemotherapy Final stage patients with a life expectancy of less than 3 months Patients with diabetes Patients with a history of or expected delay in disturbances in wound healing Known or suspected allergy to any of the components in TachoSil®
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary measurement will be assessment of kidney function at follow up relative to kidney function at inclusion. Kidney function will be evaluated by means of intravenous renography and GFR (glomerular filtration rate). A reduction in kidney function of 10% in one side measured by renography will be regarded as indicative of ureteral stenosis and a reduction of GFR 25% will indicate bilateral reduction/stenosis. . The kidney function will be assessed by intravenous renography and Glomerular Filtration Rate (GRF) at follow up after 2-3 months and 1 year after discharge. These two tests are chosen for evaluation of kidney function as they are the tests with a high level of evidence. All patients with reduced kidney function shown in one or both tests will be evaluated whether the reduction is caused by stenosis or other reasons (infections etc.). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Control groups will be data from hospital record |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Control will be data from hospital record |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |