NCT02823678

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

7.2 years

First QC Date

June 27, 2016

Last Update Submit

July 26, 2017

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Percent resected volume of pancreas and diabetes development

    Postoperative up to one year

Secondary Outcomes (2)

  • QLQ-C30 Quality of Life Health Questionnaire

    Postoperative up to one year

  • Blood glucose control

    Postoperative up to one year

Study Arms (1)

Pancreatectomy

Patients scheduled to undergo a pancreatectomy

Procedure: Pancreatectomy

Interventions

PancreatectomyPROCEDURE

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

Pancreatectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 patients scheduled to undergo a pancreatectomy for a pancreatic neoplasm

You may qualify if:

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

You may not qualify if:

  • 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%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreatectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Alexander Rosemurgy, MD

    Florida Hospital Tampa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of General Surgery

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 6, 2016

Study Start

October 1, 2013

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

July 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share