Pancreatectomy Clinical Trials

Clinical trials related to Pancreatectomy Procedure

Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Zhongshan Hospital, Fudan University
NOT_YET_RECRUITING
Shanghai
Portugal
Botton/Chamaplimaud Pancreatic cancer center
NOT_YET_RECRUITING
Lisbon
ULS São João
RECRUITING
Porto
Contact Information
Primary
Tiago Bouça-Machado, MD
tiago.machado@chsj.min-saude.pt
+351 225 512 100
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 20
Treatments
Experimental: Experimental arm
Pancreatectomy, combined with complete cytoreduction and HIPEC
Related Therapeutic Areas
Sponsors
Collaborators: Universitätsklinikum Hamburg-Eppendorf, Shanghai Zhongshan Hospital, Leiden University Medical Center, The Champalimaud Centre, Lisbon, Portugal
Leads: Unidade Local de Saúde São João

This content was sourced from clinicaltrials.gov

Similar Clinical Trials