About this trial
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.
Eligibility criteria
Qualifiers
Pancreatic adenocarcinoma
Histologically confirmed peritoneal metastasis
Excluded other sites of metastasis (except ovary)
PCI less than or equal to 6
Disqualifiers
Pregnancy
Intestinal obstruction
Renal insufficiency (GFR < 45 ml/min)
Trial design
Treatments tested in this trial
- Pancreatectomy
- Complete Cytoreduction
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Treatment groups
Sponsors and collaborators
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