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Pancreas Volume and Diabetes Status Following Pancreatectomy

Using Pancreatic Volumetric to Determine the Onset of Diabetes Mellitus and Postoperative Outcomes After Pancreatectomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02823678
Enrollment
100
Registered
2016-07-06
Start date
2013-10-31
Completion date
2021-12-31
Last updated
2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Brief 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. 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.

Interventions

PROCEDUREPancreatectomy

Patients will undergo pancreatectomy as part of routine care for their pancreatic neoplasms.

Sponsors

Florida Hospital Tampa Bay Division
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients undergoing pancreatectomy at our institution (e.g., pancreaticoduodenectomy, distal pancreatectomy, distal pancreatectomy and splenectomy, central pancreatectomy).

Exclusion criteria

* 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%).

Design outcomes

Primary

MeasureTime frame
Percent resected volume of pancreas and diabetes developmentPostoperative up to one year

Secondary

MeasureTime frame
QLQ-C30 Quality of Life Health QuestionnairePostoperative up to one year
Blood glucose controlPostoperative up to one year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026