Hepatic Resection for Metastatic Pancreatic Cancer

Neoplasm Metastasis Clinical Trial

Official title:

Hepatic Resection for Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02892305
• Other study ID #: Pro00073208
• Status: Active, not recruiting
• Start date: May 18, 2018
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: June 30, 2027
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Metastases
• Neoplasm Metastasis
• Neoplasms
• Pancreatic Neoplasms

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.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day mortality	Number of deaths within 90 days of operation	90 days postoperatively
Primary	Disease Progression	Time to disease progression	up to 1 year postoperatively
Primary	Overall Survival	Number of months until death	up to 1 year postoperatively
Secondary	Postoperative length of stay	Number of days in the hospital post-surgery	90 days postoperatively
Secondary	Frequency of pancreatic leak	Number of leaks (Types A, B, C and bile)	1-2 weeks postoperatively
Secondary	Readmission to hospital	Number of patients readmitted to the hospital post-operatively	90 days postoperatively
Secondary	Margin status	Number of patients with positive margins	90 days postoperatively
Secondary	Lymph node status	Number of positive lymph nodes	90 days postoperatively
Secondary	Time to Adjuvant therapy	Length of time to treatment after surgery	Up to 5 years postoperatively
Secondary	OR time	Length of time in the OR during surgery	1-2 days
Secondary	Intraoperative estimated blood loss	Amount of blood loss during surgery in milliliters	1-2 days