Clinical trial · Observational
Early Recurrence After Surgery for Pancreatic Cancer
Early Recurrence and Futility After Curative-intent Resection of Pancreatic Ductal Adenocarcinoma
- 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 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.
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 Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Recurrent Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curative-intent resection (R0, R1) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Curative-intent resection cohort
- description
- Adult patients with histologically confirmed PDAC who undergo curative-intent resection (R0 or R1), with no distant metastases, including both upfront and post-neoadjuvant cases.
- interventionNames
- Procedure: Curative-intent resection (R0, R1)
Primary outcomes (1)
- measure
- Incidence, timing, mode of detection, and anatomical site of early recurrence
- timeFrame
- Within 12 months post-surgery
- description
- 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.
Secondary outcomes (5)
- measure
- Comparison of ER patterns in patients treated with neoadjuvant therapy versus upfront surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available