Pancreas Volume and Diabetes Status Following Pancreatectomy

• Conditions: Pancreatic Neoplasms
• Interventions: Procedure: Pancreatectomy

• Registration Number: NCT02823678
• Lead Sponsor: Florida Hospital Tampa Bay Division

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pancreatectomy	Pancreatectomy	Patients scheduled to undergo a pancreatectomy

Primary Outcome Measures

Name	Time	Method
Percent resected volume of pancreas and diabetes development	Postoperative up to one year

Secondary Outcome Measures

Name	Time	Method
Blood glucose control	Postoperative up to one year
QLQ-C30 Quality of Life Health Questionnaire	Postoperative up to one year