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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |

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. |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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
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 |
pancreaticoduodenectomy Whipple |
Pancreatic Diseases Digestive System Diseases |