Clinical trial NCT02892305: Hepatic Resection for Metastatic Pancreatic Cancer
Official title: Hepatic Resection for Metastatic Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Neoplasms
Neoplasm Metastasis
Liver Metastases
Keywords: Pancreaticoduodenectomy
Hepatectomy
Liver ablation
Whipple
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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).

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 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

Primary outcomes:
measure: 90-day mortality
timeFrame: 90 days postoperatively
measure: Disease Progression
timeFrame: up to 1 year postoperatively
measure: Overall Survival
timeFrame: up to 1 year postoperatively
Secondary outcomes:
measure: Postoperative length of stay
timeFrame: 90 days postoperatively
measure: Frequency of pancreatic leak
timeFrame: 1-2 weeks postoperatively
measure: Readmission to hospital
timeFrame: 90 days postoperatively
measure: Margin status
timeFrame: 90 days postoperatively
measure: Lymph node status
timeFrame: 90 days postoperatively
measure: Time to Adjuvant therapy
timeFrame: Up to 5 years postoperatively
measure: OR time
timeFrame: 1-2 days
measure: Intraoperative estimated blood loss
timeFrame: 1-2 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: Sabino Zani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.