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Hepatic Resection for Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02892305
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date August 29, 2016
First Posted Date September 8, 2016
Last Update Posted Date May 23, 2019
Actual Study Start Date May 18, 2018
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2018)
  • 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
Original Primary Outcome Measures
 (submitted: September 1, 2016)
  • 90-day mortality [ Time Frame: 90 days postoperatively ]
  • disease-free survival [ Time Frame: up to 5 years postoperatively ]
  • overall mortality [ Time Frame: up to 5 years postoperatively ]
Change History Complete list of historical versions of study NCT02892305 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 26, 2018)
  • 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
Original Secondary Outcome Measures
 (submitted: September 1, 2016)
  • surgical site infection [ Time Frame: 90 days postoperatively ]
  • bleeding postoperatively [ Time Frame: 90 days postoperatively ]
  • pancreatic leak [ Time Frame: 1-2 weeks postoperatively ]
  • blood clot [ Time Frame: 90 days postoperatively ]
  • reoperation [ Time Frame: 90 days postoperatively ]
  • Readmission to hospital [ Time Frame: 90 days postoperatively ]
  • tumor histology [ Time Frame: 1-3 weeks postoperatively ]
  • Margin status [ Time Frame: 90 days postoperatively ]
  • Lymph node status [ Time Frame: 90 days postoperatively ]
  • CA 19-9 levels [ Time Frame: 90 days postoperatively ]
  • disease-free survival [ Time Frame: 90 days postoperatively ]
  • time to start of therapy from diagnosis [ Time Frame: at enrollment ]
  • OR time [ Time Frame: 1-2 days ]
  • intraoperative transfusion [ Time Frame: 1-2 days ]
  • fluid administration intraoperatively [ Time Frame: 1-2 days ]
  • estimated blood loss [ Time Frame: 1-2 days ]
  • time to end of therapy from diagnosis [ Time Frame: 90 days postoperatively ]
  • use of extraoral feeding [ Time Frame: 1-3 weeks postoperatively ]
  • use of neoadjuvant therapy [ Time Frame: at enrollment ]
  • use of adjuvant therapy [ Time Frame: 90 days postoperatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hepatic Resection for Metastatic Pancreatic Cancer
Official Title Hepatic Resection for Metastatic Pancreatic Cancer
Brief Summary 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.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with biopsy-proven, or radiographically evident, resectable pancreatic head cancer after at least 6 months of neoadjuvant therapy who are found to have low-volume hepatic metastases at time of pancreaticoduodenectomy.
Condition
  • Pancreatic Neoplasms
  • Neoplasm Metastasis
  • Liver Metastases
Intervention 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.

Other Names:
  • Whipple
  • Hepatectomy
  • Microwave Ablation
Study Groups/Cohorts PAC with LVLM
Patients with pancreatic cancer and low-volume liver metastasis
Intervention: Procedure: Hepatic Resection or Ablation with Pancreaticoduodenectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 26, 2018)
10
Original Estimated Enrollment
 (submitted: September 1, 2016)
50
Estimated Study Completion Date August 2023
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.
  • Subject has been informed of the study procedures and the treatment and has signed an informed consent form
  • Subjects who have undergone at least six months of chemotherapy without radiologic progression of the tumor
  • less than or equal to 3 liver lesions

Exclusion Criteria:

  • Subject is not a suitable candidate for surgical intervention
  • The Hepatobiliary Multidisciplinary Committee (HDMC) disapproves of this intervention.
  • Insurance will not cover the procedure.
  • Pregnant women
  • Non-English speaking Subjects
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Diana Stephenson 919-613-5796 diana.stephenson@duke.edu
Contact: Kristen Lynam, RN 919-684-9508 kristen.lynam@duke.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02892305
Other Study ID Numbers Pro00073208
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Sabino Zani, MD Duke University Health System
PRS Account Duke University
Verification Date May 2019