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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours
Resection 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
HIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion
Zhongshan Hospital, Fudan University
Shanghai, shangaiShanghai Municipality, China
NOT_YET_RECRUITINGBotton/Chamaplimaud Pancreatic cancer center
Lisbon, Lisbon District, Portugal
NOT_YET_RECRUITINGULS São João
Porto, Portugal
RECRUITINGMortality
Measurement of postoperative mortality will be recorded
Time frame: In-hospital or 90 days after surgery
Morbidity
Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification
Time frame: In-hospital or 90 days after surgery
Quality of Life after the Procedure
Assessed at 12 months post-surgery using the standardized EORTC QLQ-C30 questionnaire
Time frame: 12 months post-surgery
Recurrence-Free Survival
Recurrence from surgery until cancer returns, or death from any cause
Time frame: 12 months from surgery
Overall Survival
12 months OS
Time frame: 12 months from surgery
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