Pancreatic NeoplasmsNCT02823678
Pancreas Volume and Diabetes Status Following Pancreatectomy
An observational study of Pancreatic Neoplasms, run by Florida Hospital Tampa Bay Division.
Trial summary
This study will enroll 100 patients scheduled to undergo a pancreatectomy. The primary objective is to develop a scoring system using pancreatic volume measured by CT scan and intraoperative measurements of the pancreas parenchyma to predict the onset of diabetes mellitus after a pancreatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Pancreatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 2021
- 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: 100 patients scheduled to undergo a pancreatectomy for a pancreatic neoplasm
Who may be able to join
- All patients undergoing pancreatectomy at our institution (e.g., pancreaticoduodenectomy, distal pancreatectomy, distal pancreatectomy and splenectomy, central pancreatectomy).
Who cannot join
- All patients who are on steroids or other medications whose potential side effects include development of diabetes mellitus or elevated blood glucose.
- Pregnant or nursing women.
- Patients with uncontrolled diabetes (HbA1c >8%).
About this study
Official title: Using Pancreatic Volumetric to Determine the Onset of Diabetes Mellitus and Postoperative Outcomes After Pancreatectomy
This study will enroll 100 patients scheduled to undergo a pancreatectomy.
The primary objective is to develop a scoring system using pancreatic volume measured by CT scan and intraoperative measurements of the pancreas parenchyma to predict the onset of diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with pre-existing diabetes to see if their diabetes worsens or improves.
Read the detailed description
The primary objective is to develop a scoring system using pancreatic volume measured by CT scan and intraoperative measurements of the pancreas parenchyma to predict the onset of diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with pre-existing diabetes to see if their diabetes worsens or improves. Patients will be followed up to one year to track their diabetes status, postoperative outcomes and quality of life.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Pancreatectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreatectomyProcedure or surgery
Patients will undergo pancreatectomy as part of routine care for their pancreatic neoplasms.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatectomy | Patients scheduled to undergo a pancreatectomy Receives: Procedure: Pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent resected volume of pancreas and diabetes development
Measured: Postoperative up to one year
Secondary outcomes (2)
QLQ-C30 Quality of Life Health Questionnaire
Measured: Postoperative up to one year
Blood glucose control
Measured: Postoperative up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startOct 2013
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Hospital Tampa Bay Division
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Rosemurgy, Florida Hospital Tampa Bay Division
- Investigators
- Alexander Rosemurgy, MD, Principal investigator, Florida Hospital Tampa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823678
- Sponsor's protocol ID
- 520670
- Status last verified
- Jul 2017
- First submitted
- 27 Jun 2016
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Pancreatic Volumetric to Determine the Onset of Diabetes Mellitus and Postoperative Outcomes After Pancreatectomy
- ClinicalTrials.gov ID
- NCT02823678
- Acronym / sponsor ID
- 520670
- Conditions
- Pancreatic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Florida Hospital Tampa Bay DivisionUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Jul 2016 (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.
This study will enroll 100 patients scheduled to undergo a pancreatectomy.
The primary objective is to develop a scoring system using pancreatic volume measured by CT scan and intraoperative measurements of the pancreas parenchyma to predict the onset of diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with pre-existing diabetes to see if their diabetes worsens or improves.
Detailed description
The primary objective is to develop a scoring system using pancreatic volume measured by CT scan and intraoperative measurements of the pancreas parenchyma to predict the onset of diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with pre-existing diabetes to see if their diabetes worsens or improves. Patients will be followed up to one year to track their diabetes status, postoperative outcomes and quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatectomy | – | Procedure: PancreatectomyPatients scheduled to undergo a pancreatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients scheduled to undergo a pancreatectomy for a pancreatic neoplasm
Key inclusion criteria (1 listed)
- All patients undergoing pancreatectomy at our institution (e.g., pancreaticoduodenectomy, distal pancreatectomy, distal pancreatectomy and splenectomy, central pancreatectomy).
Key exclusion criteria (3 listed)
- All patients who are on steroids or other medications whose potential side effects include development of diabetes mellitus or elevated blood glucose.
- Pregnant or nursing women.
- Patients with uncontrolled diabetes (HbA1c >8%).
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 |
|---|---|---|
| PancreatectomyPatients will undergo pancreatectomy as part of routine care for their pancreatic neoplasms. | Procedure or surgery | Pancreatectomy |
Primary outcome
Percent resected volume of pancreas and diabetes development
Time frame: Postoperative up to one year
2 secondary outcomes
QLQ-C30 Quality of Life Health Questionnaire
Time frame: Postoperative up to one year
Blood glucose control
Time frame: Postoperative up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Alexander Rosemurgy, MD principal investigator
Florida Hospital Tampa
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by Florida Hospital Tampa Bay Division.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jul 2017. 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?
Results are not available in the source record.
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?
Percent resected volume of pancreas and diabetes development (time frame: Postoperative up to one year). 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 28 Jul 2017.