In fall 2011, we opened a PIPAC program for patients diagnosed with advanced, therapy-resistant gastric peritoneal metastasis. Therapy was conducted in accordance with the Helsinki’s declaration. All patients gave their informed consent. The Ethics Committees of the Ruhr University Bochum, Germany expressed no objection. Access to this off-label use program was limited to patients who had a life-threatening disease, including some patients with advanced disease in reduced general condition (ECOG 3 and 4) and with large amount of ascites.
Prior to therapy, each patient was evaluated by the multidisciplinary tumor board at the Marien Hospital Herne, Ruhr-University Bochum, Germany. There were no specific inclusion or exclusion criteria, and therapeutic indication was individual. All patients had histologically verified peritoneal metastasis of gastric origin, no option for complete cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) because of poor general condition, signet cell histology, advanced PCI, and/or diffuse small bowel involvement. Most of them had previous palliative systemic chemotherapy. A few patients were medically unfit for systemic palliative chemotherapy or refused to receive it. Patients with other metastatic localization were not treated (with the exception of pleural effusion). Reduced general condition (Karnofsky ≤ 60 %), therapy-resistant ascites, and partial small bowel obstruction were not considered as exclusion criteria.
All interventions were performed under general anesthesia. After insufflation of a 12 mmHg capnoperitoneum (with open access or Veres needle), two trocars (5 and 12 mm, Kii®, Applied Medical, Düsseldorf, Germany) were inserted into the abdominal wall. Ascites were removed. Extent of peritoneal carcinomatosis was determined.19 Peritoneal biopsies were taken in all 4 quadrants, and a centimetric local peritonectomy was performed to improve accuracy of histopathology, in particular when biopsies remained negative. A micropump (MIP®, Capnomed, Villingendorf, Germany) was connected to an intravenous high-pressure injector (Arterion Mark 7®, Medrad, Germany) and inserted into the abdomen. Tightness of the abdomen was documented via a zero flow of CO2. The procedure was performed in a room equipped with laminar air flow. A pressurized aerosol containing doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9 % followed by cisplatin at a dose of 7.5 mg/m2 in a 150-ml NaCl 0.9 % was applied. Flow was 30 ml/min, and upstream pressure was 200 psi. Injection was remote-controlled and nobody remained in the room during application. The therapeutic aerosol was maintained at 12 mmHg for 30 min at 37 °C. Then, it was released safely via a Closed Aerosol Waste System (CAWS). Trocars were retracted and laparoscopy ended. No drainage was applied.
Follow-up was obtained by telephone calls until November 21st, 2013 or until death. All data were documented according to our institutional rules, including electronic archiving and video recording of the procedures. Histological tumor response was assessed by an independent anatomopathologist. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE). Analysis was retrospective. Survival was modelled in a Kaplan–Meier curve. We used SPSS for Windows (v.20.0, SPSS Inc., Chicago, IL) for analysis.
Prior to therapy, each patient was evaluated by the multidisciplinary tumor board at the Marien Hospital Herne, Ruhr-University Bochum, Germany. There were no specific inclusion or exclusion criteria, and therapeutic indication was individual. All patients had histologically verified peritoneal metastasis of gastric origin, no option for complete cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) because of poor general condition, signet cell histology, advanced PCI, and/or diffuse small bowel involvement. Most of them had previous palliative systemic chemotherapy. A few patients were medically unfit for systemic palliative chemotherapy or refused to receive it. Patients with other metastatic localization were not treated (with the exception of pleural effusion). Reduced general condition (Karnofsky ≤ 60 %), therapy-resistant ascites, and partial small bowel obstruction were not considered as exclusion criteria.
All interventions were performed under general anesthesia. After insufflation of a 12 mmHg capnoperitoneum (with open access or Veres needle), two trocars (5 and 12 mm, Kii®, Applied Medical, Düsseldorf, Germany) were inserted into the abdominal wall. Ascites were removed. Extent of peritoneal carcinomatosis was determined.19 Peritoneal biopsies were taken in all 4 quadrants, and a centimetric local peritonectomy was performed to improve accuracy of histopathology, in particular when biopsies remained negative. A micropump (MIP®, Capnomed, Villingendorf, Germany) was connected to an intravenous high-pressure injector (Arterion Mark 7®, Medrad, Germany) and inserted into the abdomen. Tightness of the abdomen was documented via a zero flow of CO2. The procedure was performed in a room equipped with laminar air flow. A pressurized aerosol containing doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9 % followed by cisplatin at a dose of 7.5 mg/m2 in a 150-ml NaCl 0.9 % was applied. Flow was 30 ml/min, and upstream pressure was 200 psi. Injection was remote-controlled and nobody remained in the room during application. The therapeutic aerosol was maintained at 12 mmHg for 30 min at 37 °C. Then, it was released safely via a Closed Aerosol Waste System (CAWS). Trocars were retracted and laparoscopy ended. No drainage was applied.
Follow-up was obtained by telephone calls until November 21st, 2013 or until death. All data were documented according to our institutional rules, including electronic archiving and video recording of the procedures. Histological tumor response was assessed by an independent anatomopathologist. Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE). Analysis was retrospective. Survival was modelled in a Kaplan–Meier curve. We used SPSS for Windows (v.20.0, SPSS Inc., Chicago, IL) for analysis.
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