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Information on Product and Application for ERBE CRYO 6. In collaboration with Dr. Schüder and Dr. Pistorius, Univ. Homburg. ERBE. 1. Cryosurgery. Cryosurgery is an addition to existing surgical methods for the treatment of hepatic metastases.
In collaboration with
Dr. Schüder and Dr. Pistorius, Univ. Homburg
Cryosurgery is an addition to existing surgical methods for the treatment of hepatic metastases.
Cryosurgery is the term used to describe tissue destruction (devitalization) using extreme cold. During this process intracellular ice is formed leading to cell necrosis.
In modern cryosurgery 4 coolants are employed:
N2O and CO2 units are not suitable for the cryosurgical treatment
of malignant tumors.
The following parameters are of particular importance for successful cryosurgery:
Compared to the beginnings of cryosurgery approx. 25
years ago the following has changed:
Improvements in cryo-technology together with the intra-operative use of ultrasound have made the reliable destruction of hepatic metastases accompanied by only minimal complications possible.
The advantages of cryosurgery in the treatment of hepatic metastases are:
*Incidence are per 100.000 population.
International Opportunities in Cancer Management - SRI International
In the Federal Republic of Germany there are an average of approx. 48.050 new cases of colon carcinoma per year.
Of these patients, approx. 7.200 develop synchronous and approx. 7.200 develop metachronous liver metastases per year
Hematogenous metastasis develops primarily in the liver and secondarily in the lungs.
All in all, of the 14.000 new cases of liver metastases, approx. 10% = 1.400 can be treated with cryotherapy.
Distribution of liver metastases according to type(Study carried out at the Univ. Homburg/Saar n = 162 Pt.)
Prognostic factors for the resection of colorectal liver metastases:
The combination of cryotherapy and resection offers patients with an unfavorable distribution of metastases a therapeutic option.
For successful cryosurgical therapy of liver metastases and liver tumors the following preconditions are of particular importance:
Two newly developed cryo contact applicators are available for the ERBE Cryo 6:
Paddle applicator, 50mm Ø, Art.-No.: 20450-070
Flat applicator, 50mm Ø, Art.-No.: 20450-071
These cryo contact applicators are particularly suitable after the resection of liver tumors.
Either the flat or the paddle applicator can be utilized depending on the localization of the resected area.
Use of these special cryo contact applicators increases the size of the safety margin after resection.
Formation of ball of ice
using flat applicator
The same conditions which apply to resection also apply to indications for cryosurgery, i.e. extra-hepatic metastases (exception: the lungs) must be precluded, basically a remedial approach.
a. Positioning of the cryoprobes with the help of a U/S - unit and dilatator sets:
1.5 cm 1 cryoprobe
2.5 cm 2 cryoprobes
3.5 cm 3 cryoprobes
5 cm 4 cryoprobes
6 cm 5 cryoprobes
>7 cm 6 cryoprobes
If the ice has formed within the liver, then the heating system can be activated immediately.
After the cryoprobe has been detached from the ball of ice, the heating system can be deactivated.4. Operative technique
b. Utilization of thermo-measuring needles
In order to completely achieve the required temperature of - 50 °C in metastases and tumors of different shapes and sizes, it will be necessary in most cases to utilize more than one cryoprobe.
When only one cryoprobe is used, the isotherm of - 50 °C will have a diameter of 22 mm after a freezing time of 15 min. The entire ball of ice will be approx. 45 mm . This means that the outer margin of the iceball of 1 cm will not be sufficient for cell necrosis. It will be therefore necessary to freeze an area of at least 1 cm over and above the actual tumor margin. This can easily be monitored sonographically.
Fig. 12 clearly shows that with the synergistic use of three concurrent cryoprobes it is possible to achieve an extremely high isotherm of - 50 °C.
Fig. 125. Temperature distribution in liver tissue
Fig. 135. Temperature distribution in liver tissue
Rate of necrosis correlated with tissue temperature
(Gage et al. 1985)
Temperature °CRate of necrosis (%)
-15 to -24 72.7
-25 to -35 93.1
-36 to -50 100.05. Temperature distribution in liver tissue
Cryotherapy: Operation time
Average: 230 minutes (90 - 330)
Example: Ultrasound 10‘
Positioning of the probes 30‘
3 - 4 freezing cycles 60‘
Defrosting stage 25‘
Tumor-staging is carried out using an U/S - transducer 3.5 MHz. The sterile dilatator set is particularly suitable for the percutaneous positioning of cryoprobes.7. Percutaneous cryosurgery of hepatic tumors
The following OPs were carried out at the University Clinic of
Homburg from 8/1995 to 8/1998:
Resection + Cryo 37
Metastases total 249
- Cryo 147
- Resection 80
- Freezing of resection margins using paddle applicator 3 x
No. of metastases per patient 2 - 8
Average size 3.4 2.2 cm
No. of cryoprobes per patient
- open 3 - 5
- percutan. 4
Average rate of survival 48 months
1. Local chemotherapy
Hepatocellular carcinomas (HCC) do not respond well to systemic chemotherapy. Nor have the benefits of a local arterial chemotherapy or chemo-embolisation been clearly demonstrated. The median rate of survival with irresectable HCC is between 4 -6 months.
2. Ethanol injection (Only for HCC)
For ethanol injection 2 - 6 ml 100% alcohol is injected using a 22 - gauge needle which is positioned in the tumor under local anesthesia under ultrasound monitoring. This creates a diffuse necrosis in and around the tumor.
The injection can be administered twice a week.
This form of therapy is not successful for single tumors with a diameter of more than 5 cm or for advanced cirrhosis of the liver.
More than half of the patients develop a fever after receiving therapy.
3. Laser-induced thermotherapy (LITT)
Laser-induced thermotherapy (LITT) is a minimally invasive method of treatment for the local destruction of solid tumors and metastases in the liver, brain, breast and in ENT - therapeutics.
This technique was first carried out in 1983 using a Nd:YAG - laser.
Low-powered laser light (3.3 - 8.8 watt) is applied directly into the inner area of the tumor using thin optical fibers and leads to a coagulation necrosis.
Positioning of the fibers is carried out under CT - control. For the laser application, the patient must be removed to the MRT - measuring room. A metastasis measuring up to 2 cm can be treated with a laser applicator. One treatment session takes between 10 - 30 minutes.
As it is only possible to insert one applicator, larger metastases must be treated over a period of several sessions which is extremely time-consuming.
During electrotherapy (HF) thin isolated electrodes are positioned in the metastases under ultrasound monitoring. Additional needles are then extended in an umbrella-like fashion into the metastasis. The ion flow which is generated locally produces heat. The temperatures of over 70°C lead to coagulation necroses. Using one electrode metastases of up to 2 cm in size can be treated. One treatment session takes between 10 - 30 minutes. Only one electrode can be used during treatment.
5. Genetic therapy
During genetic therapy, genetic material is inserted into the cells of the body.
The basic requirement for genetic therapy is the identification of defects in the course of transcription and translation. Suitable vectors are required for the introduction of genetic material into normal or abnormal tissue.
In a pilot study, 5 patients with HCC were treated by sonographically controlled percutaneous injection of p53-DNA into the tumoral nodes. 3 patients showed a tumor reduction as demonstrated by CT control.
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