Hepatic Resection for Metastatic Pancreatic Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasm Metastasis; Pancreatic Neoplasms; Liver Metastases
• Intervention / Treatment: Procedure: Hepatic Resection or Ablation with Pancreaticoduodenectomy

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 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.

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
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with biopsy-proven, or radiographically evident, resectable pancreatic head cancer who are found to have low-volume hepatic metastases at time of pancreaticoduodenectomy.

Description

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 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

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 or subject not willing to pay out of pocket.
• Pregnant women
• Non-English speaking Subjects

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.; Other Names: Hepatectomy; Whipple; Microwave Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day mortality	Number of deaths within 90 days of operation	90 days postoperatively
Disease Progression	Time to disease progression	up to 1 year postoperatively
Overall Survival	Number of months until death	up to 1 year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative length of stay	Number of days in the hospital post-surgery	90 days postoperatively
Frequency of pancreatic leak	Number of leaks (Types A, B, C and bile)	1-2 weeks postoperatively
Readmission to hospital	Number of patients readmitted to the hospital post-operatively	90 days postoperatively
Margin status	Number of patients with positive margins	90 days postoperatively
Lymph node status	Number of positive lymph nodes	90 days postoperatively
Time to Adjuvant therapy	Length of time to treatment after surgery	Up to 5 years postoperatively
OR time	Length of time in the OR during surgery	1-2 days
Intraoperative estimated blood loss	Amount of blood loss during surgery in milliliters	1-2 days

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Sabino Zani, MD, Duke Health

Publications and helpful links

General Publications

• Argentiero A, Calabrese A, Sciacovelli AM, Delcuratolo S, Solimando AG, Brunetti O. Complete Response of Synchronous Liver Metastasis in a Pancreatic Ductal Adenocarcinoma, When Surgery Could Represent a Therapeutic Option. Can J Gastroenterol Hepatol. 2020 Oct 9;2020:8679751. doi: 10.1155/2020/8679751. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): May 17, 2023
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimated): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hepatectomy; Pancreaticoduodenectomy; Whipple; Liver ablation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplastic Processes; Neoplasms; Neoplasm Metastasis; Pancreatic Neoplasms
• Other Study ID Numbers: Pro00073208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No