Early Recurrence and Futility After Curative-intent Resection of Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence, timing, mode of detection, and anatomical site of early recurrence
研究概览
简要总结
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.
详细描述
This international, prospective, multicenter observational study aims to characterize early recurrence (ER) after curative-intent resection of pancreatic ductal adenocarcinoma (PDAC). ER is defined as recurrence occurring within 12 months following surgery.
The study will assess the incidence, timing, anatomical sites, and detection mode (radiologic vs. biochemical) of ER, as well as post-recurrence treatment patterns and short-term outcomes. Secondary aims include comparison between neoadjuvant and upfront surgery cohorts, evaluation of biochemical-only recurrence, and identification of clinical or pathological factors predictive of ER.
Consecutive eligible patients will be enrolled from high-volume pancreatic surgery centers worldwide and followed according to institutional standards of care, typically involving routine imaging and CA19-9 surveillance. Standardized data will be prospectively collected to describe recurrence patterns and post-recurrence management. No study-specific interventions are required.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence, timing, mode of detection, and anatomical site of early recurrence
时间窗: 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.
次要结局
- Comparison of ER patterns in patients treated with neoadjuvant therapy versus upfront surgery(12 months post-surgery)
- Incidence and clinical impact of biochemical-only recurrence(12 months post-surgery)
- Post-recurrence treatment strategies and short-term survival outcomes(From recurrence up to 24 months post-surgery)
- Clinical and pathological predictors of early recurrence(Up to 12 months post-surgery)
- Validation of futility criteria for upfront surgery patients(Within 6 months post-surgery)
研究者
Prof. Umberto Cillo
Professor
Azienda Ospedaliera di Padova