NCT07827911尚未招募不适用
Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity
Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2027年1月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Performance of the Immunological Signature for Prediction of Clinically Relevant Postoperative Pancreatic Fistula (POPF)
研究概览
简要总结
The goal of this observational study is to develop and validate a preoperative immunological signature for predicting postoperative pancreatic fistula (POPF) in adult patients undergoing pancreatic surgery for pancreatic cancer.
The main questions it aims to answer are:
- Can a preoperative immunological signature accurately predict the occurrence of postoperative pancreatic fistula after pancreatic surgery?
- Does the immunological signature provide better predictive performance than currently available predictors? Researchers will also evaluate whether the immunological signature is associated with postoperative readmission, 90-day mortality, and early disease recurrence within one year after surgery.
Participants will:
- Provide a blood sample during the preoperative assessment visit.
- Provide a second blood sample on the day following pancreatic surgery.
- Undergo standard postoperative and oncological follow-up for up to 12 months. This is a prospective, multi-center, open-label observational study conducted at Institut Paoli-Calmettes. A total of 310 participants will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Written informed consent provided prior to study participation.
- •Patient scheduled to undergo curative-intent pancreatic surgery, with or without neoadjuvant treatment; preoperative biopsy is not required.
- •Affiliated with, or beneficiary of, a national health insurance scheme
- •Non inclusion Criteria:
- •Patients scheduled to undergo total pancreatectomy for oncologic indications (e.g., intraductal papillary mucinous neoplasm [IPMN]). However, if a total pancreatectomy is decided intraoperatively because of a high risk of postoperative pancreatic fistula (POPF), preoperative study data and biological samples will remain eligible for inclusion in analyses comparing immunological signatures, in accordance with current clinical practice
- •Individuals in emergency situations, adults under legal protection (guardianship, curatorship, or judicial protection measures), or individuals unable to provide informed consent.
- •Inability to comply with study follow-up procedures for geographic, social, or psychological reasons.
排除标准
- 未提供
研究组 & 干预措施
Patients undergoing pancreatic surgery
Adult (≥18 years) undergoing elective pancreatic surgery, for a benign or malignant pancreatic tumor. Participants will provide blood samples before surgery and on the first postoperative day for immunological and proteomic analyses aimed at developing and validating a predictive signature of postoperative pancreatic fistula (POPF).
干预措施: blood sampling (Other)
结局指标
主要结局
Performance of the Immunological Signature for Prediction of Clinically Relevant Postoperative Pancreatic Fistula (POPF)
时间窗: 90 days after pancreatic surgery
次要结局
- One-Year Recurrence-Free Survival and Correlation With Immune Signature(1 year after surgery)
- 90-day Mortality(90 days)
- Change in PreCyte Score Between Preoperative and Postoperative Assessments(From preoperative assessment (within 21 days before surgery) to postoperative day 1)
- Predictive Performance of the Immune Signature for 90-Day Readmission and Mortality(90days after surgery)
- Comparison of Postoperative PreCyte Score, Drain Fluid Amylase, and C-Reactive Protein for Outcome Prediction(Postoperative period up to 90 days after surgery.)
研究者
研究点 (1)
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