Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy

Duke University

Status: Completed

Conditions: Pancreatic Disease

Treatments: Procedure: traditional pancreaticoduodenectomy; Procedure: minimally invasive pancreaticoduodenectomy

Study type: Observational

Funder types: Other

Identifiers

NCT02638818

Pro00064629

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

57 participants in 2 patient groups

minimally invasive whipple

Description:

Surgical technique (minimally invasive vs open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.

Treatment:

Procedure: minimally invasive pancreaticoduodenectomy

traditional whipple

Description:

Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.

Treatment:

Procedure: traditional pancreaticoduodenectomy