To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pancreatectomy, Complete Cytoreduction, Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
- Who it may be relevant to
- Registry conditions: Pancreatic Adenocarcinoma, Peritoneal (Metastatic) Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China, Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS Trial
Overview
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.
Interventions
- Procedure Pancreatectomy
Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours - Procedure 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 - Other Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
HIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion
Primary outcome measures
- Mortality [Time frame: In-hospital or 90 days after surgery]
- Morbidity [Time frame: In-hospital or 90 days after surgery]
Secondary outcome measures (3)
- Quality of Life after the Procedure [Time frame: 12 months post-surgery]
- Recurrence-Free Survival [Time frame: 12 months from surgery]
- Overall Survival [Time frame: 12 months from surgery]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Portugal · 2 centers
- Botton/Chamaplimaud Pancreatic cancer center — Lisbon
- ULS São João — Porto
China · 1 center
- Zhongshan Hospital, Fudan University — Shanghai
Identifiers
NCT: NCT07493421 · CE-67-2026