Curative-intent resection (R0, R1): Standard-of-care surgical resection for pancreatic ductal adenocarcinoma, as determined by the multidisciplinary team. No study-specific interventions are mandated.
Study summary
The goal of this observational study is to learn about early recurrence after curative-intent surgery for pancreatic cancer. The main questions it aims to answer are:
* How often does early recurrence (within 12 months after surgery) occur?
* When does it happen, and at which anatomical sites (liver, lung, local, peritoneum)?
* How is recurrence detected (imaging or tumor markers)?
Adults with histologically confirmed pancreatic ductal adenocarcinoma who undergo curative-intent resection without distant metastases will be enrolled. Participants will be followed according to routine clinical care at each hospital, typically with imaging and CA19-9 blood tests. No study-specific interventions are required.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥18 years
* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC)
* Undergoing curative-intent resection (R0 or R1)
* No evidence of distant metastasis at the time of surgery
* Availability of preoperative CA19-9 value and pancreas-protocol CT or MRI
* Ability to provide written informed consent
Exclusion Criteria:
* Withdrawal of informed consent
* Pathological diagnosis other than PDAC (e.g., neuroendocrine tumor, acinar cell carcinoma, invasive IPMN)
* Surgery performed for palliative or diagnostic purposes only
* Intraoperative discovery of unresectable disease or distant metastases
* Gross residual disease (R2 resection)
* Incomplete clinical or radiologic follow-up precluding recurrence assessment
* Absence of adequate preoperative contrast-enhanced pancreas-protocol CT or MRI preventing accurate staging and metastatic evaluation
* Interval \>9 months between two consecutive follow-up visits
* Major protocol deviations or insufficient data, as judged by the site investigator
Primary outcome measure(s)
Incidence, timing, mode of detection, and anatomical site of early recurrence — Within 12 months post-surgery Early recurrence (ER) is defined as disease recurrence occurring within 12 months after curative-intent resection (R0 or R1) for pancreatic ductal adenocarcinoma. The incidence, time from surgery to recurrence, mode of detection (radiologic vs biochemical), and anatomical site (liver, lung, local, peritoneum, multiple) will be prospectively assessed.
Trial sites (1)
Facility
City
Region
Status
University of Padova
Padova
PD
More Azienda Ospedaliera di Padova trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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