Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy

NCT02638818 | Completed

• 1 other identifier: Pro00064629
• Study Type: observational
• Target: 57
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Disease

Keywords

pancreaticoduodenectomy; Whipple

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

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.

minimally invasive whipple

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.

traditional whipple

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for pancreaticoduodenectomy will be eligible for this study.

You may qualify if:

• 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

You may not qualify if:

• Subject is not a suitable candidate for PD

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 23, 2015
• Study Start: July 25, 2016
• Primary Completion: September 10, 2019
• Study Completion: September 10, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01