Surgical Approach for Adenocarcinoma of the Pancreas With Synchronous Liver Metastases
2 other identifiers
observational
90
1 country
1
Brief Summary
The study focuses on patients with synchronous liver metastasis from pancreatic adenocarcinoma that underwent both pancreatic and liver resection. The control group is made up of patients with resectable or borderline resectable pancreatic adenocarcinoma and synchronous liver metastasis that were excluded from surgery. Short and long-term outcomes will be compared to evaluate the safety and efficacy of simultaneous liver and pancreatic resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFirst Submitted
Initial submission to the registry
April 7, 2025
CompletedFirst Posted
Study publicly available on registry
May 20, 2025
CompletedMay 20, 2025
May 1, 2025
2.6 years
April 7, 2025
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall survival
3 years
Recurrence-free survival
3 years
Secondary Outcomes (1)
Post-operative short-term outcomes 1
90 days
Other Outcomes (2)
Post-operative short-term outcomes 2
up to 100 weeks
Post-operative short-term outcomes 3 (histology)
up to 100 weeks
Study Arms (2)
Surgical group
Patients that underwent pancreatic and liver surgery
Non-surgical group
Patients that underwent CHT alone
Interventions
Surgery for synchronous liver metastasis from PDAC with or without previous neoadjuvant chemotherapy
Chemotherapy alone in potentially resectable patients with PDAC and synchronous liver metastasis
Eligibility Criteria
Patients underwent liver resection for synchronous metastases from pancreatic adenocarcinoma, single or multiple metastasis, will be included in the study, without any time interval limitation. Clinical features, operative data and chemotherapy regimens will be analyzed. A control group of non-surgical patients will be included in the study for a propensity score match. Setting * No time interval limitation for recruitment * No volume-based restriction for center eligibility
You may qualify if:
- Patients of age \>18, underwent surgery for pancreatic adenocarcinoma (duodenopancreatectomy, distal pancreatectomy, total pancreatectomy) and liver resection (major or minor) for synchronous metastasis, that received neoadjuvant and/or adjuvant chemotherapy.
- The control group is made up of patients age \>18 with resectable or borderline resectable pancreatic adenocarcinoma and synchronous liver metastasis that didn't underwent surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOU di Modena
Modena, 41124, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
April 7, 2025
First Posted
May 20, 2025
Study Start
June 1, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
May 20, 2025
Record last verified: 2025-05