Pancreas Volume and Diabetes Status Following Pancreatectomy | NCT02823678

Studies
Pancreas Volume and Diabetes Status Following Pancreatectomy

NCT02823678

Sponsor

Florida Hospital Tampa Bay Division

Status

Unknown status

Last Update Posted

Jul 28, 2017Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Pancreatic Neoplasms

Interventions

Pancreatectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Jun 27, 2016

First Submission Date that Met QC Criteria

Jun 30, 2016

First Posted Date

Jul 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2017

Last Update Posted Date

Jul 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexander Rosemurgy, Chief of General Surgery, Florida Hospital Tampa Bay DivisionPrincipal Investigator

Lead Sponsor

Florida Hospital Tampa Bay DivisionOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pancreatectomy		Patients scheduled to undergo a pancreatectomy	Procedure: Pancreatectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pancreatectomy	Procedure	Patients will undergo pancreatectomy as part of routine care for their pancreatic neoplasms.	Pancreatectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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%).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

100 patients scheduled to undergo a pancreatectomy for a pancreatic neoplasm

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander Rosemurgy, MD	Florida Hospital Tampa	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010180	Pancreatectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided