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

Unidade Local de Saúde São João

Status: Enrolling

Conditions: Peritoneal (Metastatic) Cancer; Pancreatic Adenocarcinoma

Treatments: Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC); Procedure: Pancreatectomy; Procedure: Complete Cytoreduction

Study type: Interventional

Funder types: Other

Identifiers

NCT07493421

CE-67-2026

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Pregnancy
• Intestinal obstruction
• Renal insufficiency (GFR < 45 ml/min)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Experimental arm

Experimental group

Description:

Pancreatectomy, combined with complete cytoreduction and HIPEC

Treatment:

Procedure: Complete Cytoreduction

Procedure: Pancreatectomy

Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)