Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy

NCT ID: NCT02638818

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-25
• Study Completion Date: 2019-09-10

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

minimally invasive pancreaticoduodenectomy

Intervention Type: 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

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 pancreaticoduodenectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Pro00064629

Identifier Type: -

Identifier Source: org_study_id