Pancreas Volume and Diabetes Status Following Pancreatectomy

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02823678
• Other study ID #: 520670
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 27, 2016
• Last updated: July 26, 2017
• Start date: October 2013
• Est. completion date: December 2021

Study information

• Verified date: July 2017
• Source: Florida Hospital Tampa Bay Division
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%).

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Procedure:
• Pancreatectomy
Patients will undergo pancreatectomy as part of routine care for their pancreatic neoplasms.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital Tampa Bay Division

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent resected volume of pancreas and diabetes development		Postoperative up to one year
Secondary	QLQ-C30 Quality of Life Health Questionnaire		Postoperative up to one year
Secondary	Blood glucose control		Postoperative up to one year