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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnidade Local de Saúde São João

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

20 Participants
are divided into 1 treatment group

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