Registry of Pancreatic Disease | NCT03807687

Studies
Registry of Pancreatic Disease

NCT03807687

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Status

Recruiting

Last Update Posted

Jan 17, 2019Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Pancreatic Diseases
Pancreatic Neoplasms
Pancreatitis

Interventions

Not provided

Countries

Italy

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Dec 1, 2046Estimated

Completion Date

Dec 1, 2046Estimated

First Submitted Date

Jan 15, 2019

First Submission Date that Met QC Criteria

Jan 15, 2019

First Posted Date

Jan 17, 2019Actual

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

Jan 15, 2019

Last Update Posted Date

Jan 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 clinical data registry records information about the health status and healthcare performances received by participants affected by every type of pancreatic disease or disorder. All data (demographic, clinical, biochemical, radiological, pharmacological, genetic...) and audio and/or video recording from operative room are collected in order to be used for prospective or retrospective studies.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

27 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with pancreatic disease		Patients diagnosed with pancreatic disease evaluated at this institution.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Survival from Diagnosis to time of death	1 year

Secondary Outcomes

Measure	Description	Time Frame
Postoperative morbidity	Occurrence of Pancreatic Fistula, Biliary fistula, Enteric fistula, Delayed Gastric Emptying, Hemorrhage or Sepsis.	90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any type of pancreatic disease: inflammatory and neoplastic (including solid and cystic lesions)

Exclusion Criteria:

physically or mentally inability to provide consent

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

Every patient affected by pancreatic disease admitted to General and Pancreatic Surgery Department of Verona University Hospital from 01/01/1990 to 12/01/2046

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Erica Secchettin	Contact	+390458126254		erica.secchettin@aovr.veneto.it

Overall Officials

Name	Affiliation	Role
Claudio Bassi, Prof	AOUI Verona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOUI Verona	Recruiting	Verona		37124	Italy

Condition Browse Module

MeSH Terms

ID	Term
D010182	Pancreatic Diseases
D010190	Pancreatic Neoplasms
D010195	Pancreatitis

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided