Clinical trial · Interventional
To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.
Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Peritoneal (Metastatic) Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complete Cytoreduction | Procedure | — | UNRESOLVED |
| Hyperthermic Intraperitoneal Chemotherapy (HIPEC) | Other | — | UNRESOLVED |
| Pancreatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Pancreatectomy, combined with complete cytoreduction and HIPEC
- interventionNames
- Procedure: Pancreatectomy
- Procedure: Complete Cytoreduction
- Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Primary outcomes (2)
- measure
- Mortality
- timeFrame
- In-hospital or 90 days after surgery
- description
- Measurement of postoperative mortality will be recorded
- measure
- Morbidity
- timeFrame
- In-hospital or 90 days after surgery
- description
- Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available