Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Disease

Intervention / Treatment
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* Procedure: minimally invasive pancreaticoduodenectomy
* Procedure: traditional pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| minimally invasive whipple<br>Surgical technique (minimally invasive vs open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm. | Procedure: minimally invasive pancreaticoduodenectomy<br>* Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.<br>|
| traditional whipple<br>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<br>* Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreaticoduodenectomy, Whipple