Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02638818

Enrollment

Registered

2015-12-23

Start date

2016-07-25

Completion date

2019-09-10

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Disease

Keywords

pancreaticoduodenectomy, Whipple

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.

Interventions

PROCEDUREminimally 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.

PROCEDUREtraditional 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026