Pancreatic DiseaseNCT02638818
Outcomes in Minimally Invasive Versus Open Pancreaticoduodenectomy
An observational study of Pancreatic Disease, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Disease
- What is being tested?
- minimally invasive pancreaticoduodenectomy and traditional pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2016to 10 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for pancreaticoduodenectomy will be eligible for this study.
Who may be able to join
- 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
Who cannot join
- Subject is not a suitable candidate for PD
About this study
Official title: A Pilot Study Evaluating Health-related Quality of Life Endpoints in Patients Undergoing Minimally Invasive Versus Open Pancreaticoduodenectomy
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
- Being tested
- minimally invasive pancreaticoduodenectomy, traditional pancreaticoduodenectomy
- Keywords
- pancreaticoduodenectomy, Whipple
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive pancreaticoduodenectomyProcedure or surgery
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 pancreaticoduodenectomyProcedure or surgery
Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: traditional pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life, as measured by FACT-Hep score
The summed overall FACT-Hep score (0-180) will be the primary outcome.
Measured: Baseline (before surgery), at hospital discharge (up to approximately 14 days), at first clinic visit (within 2 weeks after discharge), 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study start25 Jul 2016
- Primary completion10 Sep 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638818
- Sponsor's protocol ID
- Pro00064629
- Status last verified
- Jan 2020
- First submitted
- 30 Nov 2015
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Health-related Quality of Life Endpoints in Patients Undergoing Minimally Invasive Versus Open Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT02638818
- Acronym / sponsor ID
- Pro00064629
- Conditions
- Pancreatic Disease
- Keywords
- pancreaticoduodenectomy, Whipple
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive whipple | – | Procedure: minimally invasive pancreaticoduodenectomySurgical technique (minimally invasive vs open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm. |
| traditional whipple | – | Procedure: traditional pancreaticoduodenectomySurgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for pancreaticoduodenectomy will be eligible for this study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Subject is not a suitable candidate for PD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimally invasive pancreaticoduodenectomySurgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm. | Procedure or surgery | minimally invasive whipple |
| traditional pancreaticoduodenectomySurgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm. | Procedure or surgery | traditional whipple |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreatic Disease
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Disease, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.