Surgery with heated abdominal chemotherapy for pancreatic cancer spread to the abdominal lining
Tests surgery with heated abdominal chemotherapy in adults with pancreatic cancer.
Plain-language title generated from the registry record
Registry title: To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.
Key facts
- Where
- Lisbon and Porto, PortugalSee the 2 sites
Where in Portugal
- Botton/Chamaplimaud Pancreatic cancer centerLisbon, PortugalNot yet recruiting
- ULS São JoãoPorto, PortugalTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Unidade Local de Saúde São João, Oporto
- Trial code
- NCT07493421
- Record updated
- 25 March 2026
- Original description
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:Read full original descriptionShow less
Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS 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.
Inclusion: Pancreatic adenocarcinoma; Histologically confirmed peritoneal metastasis; Excluded other sites of metastasis (except ovary); PCI less than or equal to 6; Age > 18 years; ECOG performance status 0-1; Written informed consent.
Exclusion: Renal insufficiency (GFR < 45 ml/min); Pregnancy; Intestinal obstruction.