Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy

Completed

• Conditions: Pancreatic Disease
• Interventions: Procedure: traditional pancreaticoduodenectomy; Procedure: minimally invasive pancreaticoduodenectomy

• Registration Number: NCT02638818
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-23
• Study Start: 2016-07-25
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in quality of life, as measured by FACT-Hep score	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.