Pancreas Volume And Diabetes Status Following Pancreatectomy

Study Overview

Pancreas Volume and Diabetes Status Following 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.

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.

Pancreatic Neoplasms

PROCEDURE: Pancreatectomy

520670

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-06-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-07-26
First Submitted that Met QC Criteria 2016-06-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-07-28
First Posted (ACTUAL) 2016-07-06	Results First Posted N/A	Last Verified 2017-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Pancreatectomy Patients scheduled to undergo a pancreatectomy	PROCEDURE: Pancreatectomy Patients will undergo pancreatectomy as part of routine care for their pancreatic neoplasms.

Participant Group/Arm

Intervention/Treatment

: Pancreatectomy

Patients scheduled to undergo a pancreatectomy

PROCEDURE: Pancreatectomy

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

Primary Outcome Measures	Measure Description	Time Frame
Percent resected volume of pancreas and diabetes development		Postoperative up to one year

Secondary Outcome Measures	Measure Description	Time Frame
QLQ-C30 Quality of Life Health Questionnaire		Postoperative up to one year
Blood glucose control		Postoperative up to one year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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%).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Alexander Rosemurgy, MD, Florida Hospital Tampa

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record