Hepatic Resection for Metastatic Pancreatic Cancer

NCT02892305 | Active Not Recruiting DMC

• 1 other identifier: Pro00073208
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Liver Metastases

Keywords

Pancreaticoduodenectomy; Hepatectomy; Liver ablation; Whipple

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Postoperative length of stay

  90 days postoperatively

• Frequency of pancreatic leak

  1-2 weeks postoperatively

• Readmission to hospital

  90 days postoperatively

• Margin status

  90 days postoperatively

• Lymph node status

  90 days postoperatively

Study Arms (1)

PAC with LVLM

Patients with pancreatic cancer and low-volume liver metastasis

Procedure: Hepatic Resection or Ablation with Pancreaticoduodenectomy

Interventions

Hepatic Resection or Ablation with Pancreaticoduodenectomy PROCEDURE

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.

Also known as: Whipple, Hepatectomy, Microwave Ablation

PAC with LVLM

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 33102398 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

Pancreaticoduodenectomy; Hepatectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sabino Zani, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 8, 2016
• Study Start: May 18, 2018
• Primary Completion: May 17, 2023
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)