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Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638818
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Pancreatic Disease Procedure: minimally invasive pancreaticoduodenectomy Procedure: traditional pancreaticoduodenectomy

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study Evaluating Health-related Quality of Life Endpoints in Patients Undergoing Minimally Invasive Versus Open Pancreaticoduodenectomy
Actual Study Start Date : July 25, 2016
Actual Primary Completion Date : September 10, 2019
Actual Study Completion Date : September 10, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients scheduled for pancreaticoduodenectomy will be eligible for this study.
Criteria

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

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02638818    
Other Study ID Numbers: Pro00064629
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Duke University:
pancreaticoduodenectomy
Whipple
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases