The goal of this clinical trial is to evaluate the safety and feasibility of a combined surgical and chemotherapy approach (pancreatectomy with cytoreductive surgery and HIPEC) in patients aged 18 and older with pancreatic ductal adenocarcinoma and synchronous peritoneal metastases. The main questions it aims to answer are:
Is the 90-day mortality rate for this intensive combined procedure lower than 5%? What are the postoperative morbidity and complication rates (as measured by the Clavien-Dindo classification) for these patients? How does this treatment impact the patient's quality of life 12 months after the procedure?
Participants will:
Complete at least 6 months of systemic chemotherapy to ensure the disease is stable or responding (biomarker CA19-9 must decline by \>20%).
Undergo a major surgical procedure involving the removal of the pancreatic tumour (total Pancreatectomy or RAMPS) and any visible abdominal metastases (Cytoreductive Surgery).
Receive Hyperthermic Intraperitoneal Chemotherapy (HIPEC), where heated Cisplatin and Paclitaxel are circulated in the abdominal cavity for 90 minutes during the operation.
Participate in long-term follow-up to monitor recurrence-free and overall survival.
Pancreatic adenocarcinoma
Histologically confirmed peritoneal metastasis
Excluded other sites of metastasis (except ovary)
PCI less than or equal to 6
Pregnancy
Intestinal obstruction
Renal insufficiency (GFR < 45 ml/min)
Single group
Pancreatectomy
Procedure/SurgeryTotal pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours
Complete Cytoreduction
Procedure/SurgeryResection of all macroscopic peritoneal metastases, but also the greater and lesser omentum, the round ligament of the liver, the appendix and the ovaries, in case of female patients
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Other interventionHIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion
Mortality
Measurement of postoperative mortality will be recorded
Morbidity
Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification
Quality of Life after the Procedure
Assessed at 12 months post-surgery using the standardized EORTC QLQ-C30 questionnaire
Recurrence-Free Survival
Recurrence from surgery until cancer returns, or death from any cause
Overall Survival
12 months OS
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Unidade Local de Saúde São João
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborator
The Champalimaud Centre, Lisbon, Portugal
Collaborator
Leiden University Medical Center
Collaborator
Shanghai Zhongshan Hospital
Collaborator
