Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy

Overview

The purpose of this study is to evaluate the impact of the quality of life in patients undergoing the Whipple procedure (pancreaticoduodenectomy, PD) for pancreatic cancer. The Whipple procedure can be done by laparoscopic (small incisions) or an open procedure (large incision) to treat the patients cancer. The goal of this study is to see if there is any difference in quality of life between patients who undergo the laparoscopic or the open Whipple procedure. Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm. A subset of these patients will also be asked to take part in a pre- and postoperative in-depth interview to explore the lived experiences of patients with resectable pancreatic cancer.

Full Title of Study: “A Pilot Study Evaluating Health-related Quality of Life Endpoints in Patients Undergoing Minimally Invasive Versus Open Pancreaticoduodenectomy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 10, 2019

Interventions

  • Procedure: minimally invasive pancreaticoduodenectomy
    • Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.
  • Procedure: traditional pancreaticoduodenectomy
    • Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.

Arms, Groups and Cohorts

  • minimally invasive whipple
    • Surgical technique (minimally invasive vs open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.
  • traditional whipple
    • Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.

Clinical Trial Outcome Measures

Primary Measures

  • Change in quality of life, as measured by FACT-Hep score
    • Time Frame: Baseline (before surgery), at hospital discharge (up to approximately 14 days), at first clinic visit (within 2 weeks after discharge), 3 months
    • The summed overall FACT-Hep score (0-180) will be the primary outcome.

Participating in This Clinical Trial

Inclusion Criteria

  • All patients scheduled for pancreaticoduodenectomy will be eligible for this study. – 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 suitable surgical candidate, i.e. is able to undergo general anesthesia and PD for diagnosis of cancer – Subject is willing and able to cooperate with survey participation. – Subject has been informed of the study procedures and the treatment and has signed an informed consent form Exclusion Criteria:
  • • Subject is not a suitable candidate for PD

    Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Duke University
    • Provider of Information About this Clinical Study
      • Sponsor

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