The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.
The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment.
- EligibilityCriteria: Inclusion criteria  Gastric or Gastroesophageal junction Siewert type III adenocarcinomas  Clinical T3-4a-stages  Any differentiation grade Any histological subtype  Clinical T2-stage  a. If poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells  Any clinical T-stage with positivity for malignant cells on abdominal lavage cytology, which is converted to cytology negative in response to neoadjuvant chemotherapy. Any clinical nodal-stage clinical M0-stage (positive abdominal wash cytology, which is converted to cytology negative in response to neoadjuvant therapy, is permitted) Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 Age 18 - 80 years Undergoing robotic or laparoscopic D2 gastrectomy Able and willing to provide written informed consent and to comply with the clinical study protocol Fertile women must have a negative pregnancy test at the time of inclusion and must use adequate contraception.  Exclusion criteria  Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds. Renal impairment, defined as glomerular filtration rate (GFR) < 40 ml/min (Cockcroft-Gault Equation). Myocardial insufficiency, defined as New York Heart Association (NYHA) class 3-4. An impaired liver function, defined as bilirubin ≥ 1.5 x upper normal limit (UNL). An inadequate haematological function, defined as absolute neutrophil count (ANC) <1.5 x 109/l and platelets <100 x 109/l. Any other condition or therapy which, in the investigator's opinion, may pose a risk to the patient or interfere with the study objectives. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult