To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.

Condition(s) studied

Investigational drug(s) / intervention(s)

Pancreatectomy: Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours

Complete Cytoreduction: 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

Hyperthermic Intraperitoneal Chemotherapy (HIPEC): HIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion

Study summary

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

Primary outcome measure(s)

• Mortality — In-hospital or 90 days after surgery
  Measurement of postoperative mortality will be recorded
• Morbidity — In-hospital or 90 days after surgery
  Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification

Trial sites (3)

Other trials for the same condition