Pancreas Volume and Diabetes Status Following Pancreatectomy

NCT ID: NCT02823678

Last Updated: 2017-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Pancreatic Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pancreatectomy

Patients scheduled to undergo a pancreatectomy

Pancreatectomy

Intervention Type PROCEDURE

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

Interventions

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Pancreatectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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%).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida Hospital Tampa Bay Division

OTHER

Sponsor Role lead

Responsible Party

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Alexander Rosemurgy

Chief of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Rosemurgy, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital Tampa

Other Identifiers

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520670

Identifier Type: -

Identifier Source: org_study_id

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