Reliability of the Preoperative Work-up in Patients Submi... | NCT02675738

Studies
Reliability of the Preoperative Work-up in Patients Submitted to Surgery for Cystic Neoplasms of the Pancreas

NCT02675738

Sponsor

Universita di Verona

Status

Unknown status

Last Update Posted

Sep 24, 2019Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Pancreatic Cystic Neoplasms

Interventions

good clinical practice

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Dec 2018Actual

Completion Date

Jan 2020Estimated

First Submitted Date

Jan 6, 2016

First Submission Date that Met QC Criteria

Feb 4, 2016

First Posted Date

Feb 5, 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

Sep 21, 2019

Last Update Posted Date

Sep 24, 2019Actual

Description Module

Brief Summary

Prospective, observational, cohort study to evaluate the reliability of preoperative work-up of patients submitted to surgery for pancreatic cystic neoplasms, in a tertiary referral center. A comparison between the preoperative diagnostic suspicion and the final pathologic report will be done.

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

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

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
good clinical practice	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of cases with confirmed preoperative diagnosis		Through study completion, on average 18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of pancreatic cystic neoplasms
indication to surgery

Exclusion Criteria:

pregnancy, breastfeeding

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

Patients suffering from pancreatic cystic neoplasms candidate to surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giulia De Marchi, MD	Contact	+390458124055		giuli.dema@yahoo.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Verona Hospital Trust	Recruiting	Verona			Italy