An interventional study of Pancreatectomy and Complete Cytoreduction in Pancreatic Adenocarcinoma and Peritoneal (Metastatic) Cancer, sponsored by Unidade Local de Saúde São João. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Unidade Local de Saúde São João · Not applicable, Interventional, and Treatment
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 20 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Unidade Local de Saúde São João is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pancreatectomy, combined with complete cytoreduction and HIPEC
Procedure: Pancreatectomy · Procedure: Complete Cytoreduction · Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours
Also known as: Total pancreatectomy, Radical Antegrade Modular Pancreatosplenectomy, RAMPS
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
Also known as: CRS
HIPEC 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
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
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
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