Hepatic Resection for Metastatic Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02892305|
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment|
|Pancreatic Neoplasms Neoplasm Metastasis Liver Metastases||Procedure: Hepatic Resection or Ablation with Pancreaticoduodenectomy|
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 2-3 subjects per year for a total of 10 evaluable subjects.
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.
Post-operative data regarding re-admission and surveillance data for oncologic outcomes such as re-operation, final pathology margin status, nodal status, and postoperative CA 19-9, as well as DFS and OS, including date of death if applicable, during the provided follow up period.
To ensure accurate and complete incorporation of medical data, a database of perioperative outcomes will be prospectively maintained during the subject's hospital stay and for the first 3 months following surgery. Duke University is a member of the National Surgical Quality Improvement Program (NSQIP), with 100% participation in Hepatopancreaticobiliary (HPB) procedures. As such, all preoperative data and 30-day outcomes are collected by a fully trained Surgical Clinical Reviewer and are available within our electronic medical record (EMR). NSQIP provides a robust, audited dataset that has been validated to optimize the accuracy of data collection, substantially reducing the cost and resource requirements of data extraction. Following this 30-day period, data will be collected at regularly scheduled clinic visits, which typically occur weekly until 6-12 weeks post-surgery, then 3-4 months for the first year, and every 6 months thereafter and stored in a local, REDCap database.
Subjects' medical records will be continually reviewed for surgical complications and for overall survival (date of subject death).
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Hepatic Resection for Metastatic Pancreatic Cancer|
|Actual Study Start Date :||May 18, 2018|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2023|
PAC with LVLM
Patients with pancreatic cancer and low-volume liver metastasis
Procedure: Hepatic Resection or Ablation with Pancreaticoduodenectomy
Patients will undergo pancreaticoduodenectomy, or the Whipple procedure, which involves removal of the head of the pancreas, the duodenum, and a portion of the stomach, as well as the gallbladder and a portion of the bile duct.
The patient will also undergo a Hepatectomy, the surgical resection or removal of all or part of the liver or Microwave Ablation (MWA) if determined by the surgeon to be the best course of care.
- 90-day mortality [ Time Frame: 90 days postoperatively ]Number of deaths within 90 days of operation
- Disease Progression [ Time Frame: up to 1 year postoperatively ]Time to disease progression
- Overall Survival [ Time Frame: up to 1 year postoperatively ]Number of months until death
- Postoperative length of stay [ Time Frame: 90 days postoperatively ]Number of days in the hospital post-surgery
- Frequency of pancreatic leak [ Time Frame: 1-2 weeks postoperatively ]Number of leaks (Types A, B, C and bile)
- Readmission to hospital [ Time Frame: 90 days postoperatively ]Number of patients readmitted to the hospital post-operatively
- Margin status [ Time Frame: 90 days postoperatively ]Number of patients with positive margins
- Lymph node status [ Time Frame: 90 days postoperatively ]Number of positive lymph nodes
- Time to Adjuvant therapy [ Time Frame: Up to 5 years postoperatively ]Length of time to treatment after surgery
- OR time [ Time Frame: 1-2 days ]Length of time in the OR during surgery
- Intraoperative estimated blood loss [ Time Frame: 1-2 days ]Amount of blood loss during surgery in milliliters
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892305
|Contact: Diana Stephensonemail@example.com|
|Contact: Kristen Lynam, RNfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Health System||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Sabino Zani, MD 919-684-6553 email@example.com|
|Principal Investigator:||Sabino Zani, MD||Duke University Health System|