To find an energy dose for the complete destruction of a renal tumour with bipolar-multipolar RFA.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Find an energy dose that allows a complete destruction of the tumour. Tumor
destruction will be studied by histopathology-immunohistochemistry. These data
will be correlated to the energy used.
Secondary outcome
none
Background summary
There is solid evidence that partial nephrectomy (excision) is as effective as
radical (total) nephrectomy in the treatment of (srm*s=) small renal
masses/tumors (<=4 cm). Until recently, an open operation was the gold standard
approach. Laparoscopic partial nephrectomy is an emerging option. However,
laparoscopic excision is technically very demanding and has to be performed
under general anesthesia. Therefore an energy-based ablative technique that can
eventually be applied percutaneously (image-guided) and under local anesthesia
would be an important advancement. Two techniques i.e. cryoablation and
radiofrequency ablation are currently being developed. To be fully acceptable
for clinical application, the technique should ideally result in complete
destruction of the tumor. Currently used cryoablation and monopolar RFA
techniques have been shown to be feasible in the treatment of srm*s but
complete destruction of the tumor cannot yet be achieved consistently.
Study objective
To find an energy dose for the complete destruction of a renal tumour with
bipolar-multipolar RFA.
Study design
Dose finding study using a treat-and -resect protocol.
Intervention
Radiofrequency ablation (RFA) of the renal tumour in an open surgical setting
followed by partial or total nephrectomy (treat-and-resect protocol)
Study burden and risks
The total time of the operation is prolonged by the time needed for the biopsy
and the RFA. Complications of laparoscopic or percutaneous monopolar RFA are
damage to the ureter and urinoma formation; these have been reported in 3-15%
of the cases; bleeding was rarely seen [Klingler 2007]. Bipolar-multipolar RFA
in an open setting, a well-known technique for the treatment of liver masses,
is a new approach for the kidney, is likely to result in less complications.
Rheinstrasse 8
14513 Teltow
DE
Rheinstrasse 8
14513 Teltow
DE
Listed location countries
Age
Inclusion criteria
Pre-operative inclusion criteria
- Patient gives informed consent
- Patients with small renal mass [SRM] (<=4cm).
- The mass has to be a cortical tumor (not hilar)
Stop criterium
_ At the moment of procedure in case benign histology is found on frozen section biopsy, no RFA will be performed and the patient will not continue the study.
Exclusion criteria
- Pregnancy
- SRM > 4cm
- SRM in hilar area
- Clotting disorder or anticoagulant use that cannot be interrupted
- Benign histology at intraoperative biopsy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL22577.041.08 |