Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy

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.

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Key information

Conditions

Pancreatic Disease Digestive System Diseases Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

minimally invasive pancreaticoduodenectomy

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.

traditional pancreaticoduodenectomy

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

A Pilot Study Evaluating Health-related Quality of Life Endpoints in Patients Undergoing Minimally Invasive Versus Open Pancreaticoduodenectomy

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Dec 23, 2015
Registry last updated: Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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