Pancreatic Surgical Database | NCT02871336

Studies
Pancreatic Surgical Database

NCT02871336

Sponsor

Institut Paoli-Calmettes

Status

Recruiting

Last Update Posted

Aug 18, 2016Estimated

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Pancreatic Neoplasms

Interventions

Data collection

Countries

France

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

Aug 2016

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

Nov 2014

Primary Completion Date

Nov 2030Estimated

Completion Date

Not provided

First Submitted Date

Aug 3, 2016

First Submission Date that Met QC Criteria

Aug 12, 2016

First Posted Date

Aug 18, 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

Aug 12, 2016

Last Update Posted Date

Aug 18, 2016Estimated

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 data base has been set in order to gather medical and surgical information from patients who have undergone surgery for pancreatic cancer, at Institut Paoli Calmettes or Assistance Publique des Hôpitaux de Marseille, France.

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

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optimization of the surgical care of the patients	Collection of clinical and surgical data for future research studies	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient >18 ans
Surgery for a pancreatic cancer

Exclusion Criteria:

Patient refusal to participate in the study

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

Patient with a pancreatic cancer who has undergone surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dominique Genre, MD	Contact	0033491223778		drci.up@ipc.unicancer.fr
Lilian Laborde	Contact	0033491223778		labordel@ipc.unicancer.fr

Overall Officials

Name	Affiliation	Role
Olivier Turrini, MD,PhD	Institut Paoli-Calmettes	Principal Investigator
Vincent Moutardier	Assistance Publique des Hôpitaux de Marseille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Paoli Calmettes	Recruiting	Marseille	Bouches du Rhone	13009	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36801197	Derived	De Crignis L, Garnier J, Ewald J, Palen A, Piana G, Izaaryene J, Delpero JR, Turrini O. Preoperative liver arterial conditioning in patients scheduled for a Mayo Clinic class Ia distal pancreatectomy: embolization or ligation? HPB (Oxford). 2023 Apr;25(4):439-445. doi: 10.1016/j.hpb.2023.01.007. Epub 2023 Jan 20.
36437219	Derived

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

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care