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Information on Product and Application for ERBE CRYO 6

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.

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Information on Product and Application for ERBE CRYO 6

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  1. Information on Product and Application forERBE CRYO 6 In collaboration with Dr. Schüder and Dr. Pistorius, Univ. Homburg ERBE

  2. 1. Cryosurgery 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. ERBE

  3. 1. Cryosurgery In modern cryosurgery 4 coolants are employed: • Nitrous oxide (N2O) min. temperature - 80 °C • Liquid nitrogen (LN2) min. temperature - 196 °C • Carbon dioxide (CO2) min. temperature - 60 °C • Argon min. temperature - 135 °C N2O and CO2 units are not suitable for the cryosurgical treatment of malignant tumors. ERBE

  4. 1. Cryosurgery The following parameters are of particular importance for successful cryosurgery: • extreme cooling of the tumor cells (at least - 50°C) • a freezing temperature of at least - 100°C / min. • in order to freeze large metastases or tumors simultaneously, several cryoprobes can be inserted concurrently. ERBE

  5. 1. Cryosurgery Compared to the beginnings of cryosurgery approx. 25 years ago the following has changed: • Improved knowledge of cryobiology • (ice  cell necrosis, freezing times, freezing speed and freezing cycles) • Improved cryounits • (rapid freezing speed, constant power output, simultaneous insertion of several probes possible) • Improved cryoprobes • (thin, high-powered) • Improved application methods • (intra-op.-ultrasound, positioning sets) ERBE

  6. 1. Cryosurgery 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: • Treatment option for irresectable metastases of the liver • Combined OP (resection and cryosurgery) • Freezing of the edges of the resected area (to increase the safety margin) • Treatment method with minimal complications • Limited range of application means that healthy liver parenchyma is not affected ERBE

  7. 1. Cryosurgery ERBE

  8. Colorectal Cancer Worldwide incidence* U.K. Male 51,7 Female 51,3 Germany Male 40,9 Female 52,2 Netherlands Male 43,4 Female 44,6 Japan Male 47,4 Female 36,9 Italy Male 64,8 Female 58,5 France Male 51,0 Female 41,5 Spain Male 34,4 Female 30,2 U.S.A. *Incidence are per 100.000 population. International Opportunities in Cancer Management - SRI International Male 57,9 Female 40,0 ERBE

  9. 2. Liver metastases through colon carcinoma 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 ERBE

  10. Cancer of the colon and the rectumGermany 1991 MenWomentotal New cases 21.460 26.590 48.050 Synchron. liver metastases (estimated) approx. 15 % 7.200 Metachron. liver metastases (estimated) approx. 15 % 7.200 New cases of liver metastases per year 14.400 2. Liver metastases through colon carcinoma ERBE

  11. 2. Liver metastases through colon carcinoma 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. ERBE

  12. Summary 14.000 new cases of liver metastasis per year 5 - 10 % resectable = 700 - 1.400 25 - 35 % irresectable despite only few metastases 5 - 10 % treatable by cryotherapy = 700 - 1.400 2. Liver metastases through colonic carcinoma ERBE

  13. Distribution of liver metastases according to type(Study carried out at the Univ. Homburg/Saar n = 162 Pt.) ERBE

  14. 2. Liver metastases through colonic carcinoma Prognostic factors for the resection of colorectal liver metastases: • Number of metastases (3 - 10) • Tumor-free margin • Lymph-node status of the primary tumor • Interval of time between primary operation and the occurrence of metastases The combination of cryotherapy and resection offers patients with an unfavorable distribution of metastases a therapeutic option. ERBE

  15. 3. Equipment/Instruments For successful cryosurgical therapy of liver metastases and liver tumors the following preconditions are of particular importance: • A good high-resolution U/S - unit (preferably with a good radiologist) • A high-powered cryounit with a connection for multiple probes • A temperature measurement gauge to monitor tissue temperatures using temperature-measuring needles • sterile dilatator sets for the introduction and positioning of cryoprobes ERBE

  16. 3. Equipment/Instruments 10450-000 20450-001 ERBE

  17. 3. Equipment/Instruments 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. ERBE

  18. 3. Equipment/Instruments Formation of ball of ice using flat applicator 20450-071 20450-070 ERBE

  19. 3. Equipment/Instruments 20450-006 20450-008 20450-003 ERBE

  20. 3. Equipment/Instruments 20450-007 20450-002 ERBE

  21. Important requirements for the exact staging of tumors : A good U/S - unit with high resolution U/S - transducer: - for open liver procedures 5 MHz or possibly 7.5 MHz - percutaneously 3.5 MHz 3. Equipment/Instruments ERBE

  22. Intra-operative sonography Intra-operative sonography offers the following advantages: exact identification of metastases precise positioning of the cryoprobes Monitoring of ice formation . 3. Equipment/Instruments ERBE

  23. 4. Operative technique 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. ERBE

  24. 4. Operative technique a. Positioning of the cryoprobes with the help of a U/S - unit and dilatator sets: • ERBE CRYO 6 offers the possibility of utilizing up to 6 cryoprobes concurrently. • Prior to the positioning of cryoprobes in the metastases, the size of the metastases must be ascertained using U/S, in order to determine the number of cryoprobes required. The following system should be applied: ERBE

  25. 4. Operative technique • Metastases with a  up to: 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 ERBE

  26. 4. Operative technique • To begin with, the needle together with a guiding channel is precisely positioned in the metastasis under U/S - monitoring. • The needle is then removed from the channel. • A guide-wire is then introduced through the channel using the Seldinger technique. The guide-wire is provided with a J - hook at one end, which can be clearly visualized under U/S - control. The J - hook must be positioned exactly at the distal end of the channel. • The channel is then removed. A synthetic cone with the dilatator is introduced into the hepatic metastasis with the help of the guide-wire. ERBE

  27. 4. Operative technique • Cone and dilatator must be inserted up to the hook at the end of the guide-wire. • The guide-wire and the cone are then removed from the dilatator. • Once the cryoprobe has been completely inserted into the dilatator up to the very end, the dilatator is then partially retracted in order to ensure that the freezing zone of the cryoprobe lies outside of the dilatator and is correctly positioned. • Note! Dilatator sets should only be used once! ERBE

  28. 4. Operative technique • One dilatator set per cryoprobe is required. • If the patient presents with several metastases, then the same dilatator set can be reused several times. • After positioning the cryoprobes, the freezing cycle is activated. Note! The cryoprobes are only firmly positioned in the liver when the necessary freezing temperature has been reached. During freezing the cryoprobes should be held still in order to avoid creating tension between the probes (danger of cracking). ERBE

  29. . . 4. Operative technique ERBE

  30. 4. Operative technique • If the metastases are larger than 5 cm , then the cryoprobes must be withdrawn after the first cryo-cycle in order to freeze the entire metastasis during a second cryo-cycle. • After one freezing cycle (15 min at -195°C) and a period on hold (5 - 10 min at -150°C) the freezing process is halted for every cryoprobe. • If the ice extends up to the surface, then the heating system is only activated after reaching a temperature of approx. -20 °C to -30 °C, because of the danger of cracking. ERBE

  31. Once the cryoprobe has achieved a temperature above zero, then the surgeon can carefully begin to detach the probe form the ball of ice. 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 ERBE

  32. 4. Operative technique b. Utilization of thermo-measuring needles • ERBE CRYO 6 offers the possibility of utilizing up to 6 thermo-measuring needles concurrently. • With the help of the thermo-measuring needles, it is possible to measure the temperature in various tissue areas or in the vicinity of a particular vasculature or organ. • In order to ascertain whether the required freezing temperature of - 50°C has been achieved at the periphery of the metastasis, a thermo-measuring needle should be positioned within the area in question with the help of U/S monitoring. ERBE

  33. 4. Operative technique • If the cryoprobe has been properly positioned, the temperature after 15 min. should be - 50 °C. • Thermo-measuring needles are available in various different sizes, optimized for open and percutaneous operations. ERBE

  34. 5. Temperature distribution in liver tissue 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. ERBE

  35. When treating tumors larger than 20 mm , more than one cryoprobe must be utilized (s. Fig. 11). 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. 11 Fig. 12 5. Temperature distribution in liver tissue ERBE

  36. If the tumor is not circular in shape, as shown in Fig. 13, then an additional cryoprobe must be inserted. Fig. 13 5. Temperature distribution in liver tissue ERBE

  37. As early as 1985, Gage established the fact that rate of necrosis is related to tissue temperature. 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 -50 100.0 5. Temperature distribution in liver tissue ERBE

  38. 6. Operation time Cryotherapy: Operation time Average: 230 minutes (90 - 330) Example: Ultrasound 10‘ Positioning of the probes 30‘ 3 - 4 freezing cycles 60‘ Defrosting stage 25‘ -------- 125‘ ERBE

  39. Percutaneous cryosurgery is well suited for patients with hepatic tumors which can be easily localized sono-graphically. 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 ERBE

  40. . . 7. Percutaneous cryosurgery of hepatic tumors ERBE

  41. 7. Percutaneous cryosurgery of hepatic tumors • Advantages of percutaneous cryosurgery are: • no loss of blood during the operation • no intra- or postoperative complications • short period of hospitalization of about 3 - 6 days • additional percutaneous cryo -operations always possible Disadvantage: • Control of therapeutic results is problematic, particularly in tumor regions adjacent to the ultrasound ERBE

  42. 8. Cases The following OPs were carried out at the University Clinic of Homburg from 8/1995 to 8/1998: Patients 100 Resection + Cryo 37 Cryo 48 Percutan. 15 Metastases total 249 - Cryo 147 - Resection 80 - Freezing of resection margins using paddle applicator 3 x ERBE

  43. 8. Cases 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 ERBE

  44. 9. Alternative therapies for irresectable hepatic metastases and liver tumors • 1. Chemotherapy • 2. Ethanol injection • 3. Laser-induced thermotherapy • 4. Electrotherapy • 5. Genetic therapy ERBE

  45. 9. Alternative therapies for irresectable hepatic metastases and liver tumors 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. ERBE

  46. 9. Alternative therapies for irresectable hepatic metastases and liver tumors 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. ERBE

  47. 9. Alternative therapies for irresectable hepatic metastases and liver tumors 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. ERBE

  48. 9. Alternative therapies for irresectable hepatic metastases and liver tumors 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. ERBE

  49. 9. Alternative therapies for irresectable hepatic metastases and liver tumors 4. Electrotherapy 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. ERBE

  50. 9. Alternative therapies for irresectable hepatic metastases and liver tumors 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. ERBE

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