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| Name | Class |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| The Champalimaud Centre, Lisbon, Portugal | UNKNOWN |
| Leiden University Medical Center | OTHER |
| Shanghai Zhongshan Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Pancreatectomy, combined with complete cytoreduction and HIPEC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatectomy | Procedure | Total pancreatectomy for head tumours or radical antegrade modular pancreatosplenectomy (RAMPS) for distal tumours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Measurement of postoperative mortality will be recorded | In-hospital or 90 days after surgery |
| Morbidity | Post-operative morbidity will be recorded and classified according to Clavien-Dindo classification | In-hospital or 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life after the Procedure | Assessed at 12 months post-surgery using the standardized EORTC QLQ-C30 questionnaire | 12 months post-surgery |
| Recurrence-Free Survival | Recurrence from surgery until cancer returns, or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiago Bouça-Machado, MD | Contact | +351 225 512 100 | tiago.machado@chsj.min-saude.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Not yet recruiting | Shanghai | shangaiShanghai Municipality | 200000 | China |
All IPD that underlie results in a publication
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| OTHER |
Prospective, Single-Arm, Open-Label, Multicentre Feasibility Study
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| Complete Cytoreduction | Procedure | 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 |
|
|
| Hyperthermic Intraperitoneal Chemotherapy (HIPEC) | Other | HIPEC with Cisplatin (100 mg/m2) and Paclitaxel (175 mg/m2) is performed for 90 minutes in a closed fashion |
|
| 12 months from surgery |
| Overall Survival | 12 months OS | 12 months from surgery |
| Botton/Chamaplimaud Pancreatic cancer center | Not yet recruiting | Lisbon | Lisbon District | 1400-038 | Portugal |
|
| ULS São João | Recruiting | Porto | 4200-319 | Portugal |
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D010180 | Pancreatectomy |
| D001107 | Architectural Accessibility |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D005160 | Facility Design and Construction |
| D001108 | Architecture |
| D013676 | Technology, Industry, and Agriculture |
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
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