Pancreas Volume and Diabetes Status Following Pancreatectomy

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Neoplasms
• Intervention / Treatment: Procedure: Pancreatectomy

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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

100 patients scheduled to undergo a pancreatectomy for a pancreatic neoplasm

Description

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%).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pancreatectomy; Patients scheduled to undergo a pancreatectomy	Procedure: Pancreatectomy; Patients will undergo pancreatectomy as part of routine care for their pancreatic neoplasms.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Florida Hospital Tampa Bay Division
• Investigators: Principal Investigator: Alexander Rosemurgy, MD, Florida Hospital Tampa

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 520670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO