Hepatic Resection for Metastatic Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- 90-day mortality
研究概览
简要总结
The purpose of this study is to demonstrate the feasibility of an aggressive multimodal approach among patients with stage IV pancreatic cancer (PAC) with isolated, low-volume hepatic metastasis (LVHM). We will evaluate and describe the surgical and overall outcomes of an initial cohort of subjects who undergo pancreatectomy and hepatic resection/ablation for PAC with LVHM. The end of study results will be reviewed by the Hepatiobiliary Multidisciplinary Conference (HDMC) and Surgery Audit Committee (SAC) to determine the appropriateness of adding this treatment arm for patients with oligometastatic metastatic pancreatic cancer.
详细描述
This is a small interventional pilot study that will be conducted as a single-site study at Duke University Health System (DUHS). All subjects with pancreatic cancer and low-volume liver metastases (< or = 3 lesions) who meet criteria for pancreatic and liver resection will be offered the opportunity to participate. Potential subjects will be referred by the Medical Oncology physicians at Duke if they feel like the patient would be suitable for this study. We anticipate enrolling 15 subjects to include 10 evaluable subjects in the analysis.
Any subject who consents to the study will proceed with primary resection, including pancreaticoduodenectomy or distal pancreatectomy, and liver resection/ablation of the metastases.
Screening will include a medical record review, standard of care CT scan/MRI, clinical evaluation including physical, vitals, height weight and routine blood tests.
Preoperative data such as sex, race, age at resection, ASA class, race, body mass index (BMI), pretreatment staging, CA 19-9 (missing in open PD), tumor size (cm), and neoadjuvant therapy (no; yes), time to initiation and completion will also be captured.
Perioperative data like date of surgery, OR time, ASA class, intra-operative transfusion requirements, fluid administration, EBL, operative complications (including but not limited to infection, bleeding, need for re-operation, thrombus, pancreatic leak, bile leak, liver failure, nutritional data like use of TPN and tube feedings, and length of stay will be collected.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 18 years of age and at least the minimum Age of Majority according to applicable State or Country Law
- •Subject is a surgical candidate, (i.e., is able to undergo general anesthesia and surgical resection for diagnosis of cancer)
- •The Hepatobiliary Multidisciplinary Committee (HDMC) must approved of this intervention.
- •Insurance pre-authorization must be received unless the subject decides to pay out of pocket..
- •Subject has been informed of the study procedures and the treatment and has signed an informed consent form
- •less than or equal to 3 liver lesions
排除标准
- •Subject is not a suitable candidate for surgical intervention
- •The Hepatobiliary Multidisciplinary Committee (HDMC) disapproves of this intervention.
- •Insurance will not cover the procedure or subject not willing to pay out of pocket.
- •Pregnant women
- •Non-English speaking Subjects
结局指标
主要结局
90-day mortality
时间窗: 90 days postoperatively
Number of deaths within 90 days of operation
Disease Progression
时间窗: up to 1 year postoperatively
Time to disease progression
Overall Survival
时间窗: up to 1 year postoperatively
Number of months until death
次要结局
- Lymph node status(90 days postoperatively)
- OR time(1-2 days)
- Postoperative length of stay(90 days postoperatively)
- Readmission to hospital(90 days postoperatively)
- Margin status(90 days postoperatively)
- Frequency of pancreatic leak(1-2 weeks postoperatively)
- Time to Adjuvant therapy(Up to 5 years postoperatively)
- Intraoperative estimated blood loss(1-2 days)