Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN)

NCT ID: NCT04901364

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-10

Study Completion Date

2021-10-30

Brief Summary

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Cystic lesions of the pancreas are frequent with a risk of degeneration into adenocarcinoma with pejorative prognosis.

IPMNs require characterization to clarify their potential for degeneration. Clinical and morphological risk factors for degeneration determine the monitoring rate and the indication for pancreatic surgery.

Pancreatic surgery remains invasive with high morbidity and mortality rates.

Detailed Description

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This is a monoservice and monocentric retrospective study at the Nancy CHRU. We will study the risk factors for IPMNs degeneration in order to determine the most sensitive and specific.

To do this, we will use high-grade dysplasia or invasive cancer on the histological analysis of surgical specimens as the primary endpoint.

The study population will be patients with Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021.

Conditions

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Study of Risk Factors for IPMNs Degeneration at the Nancy CHRU

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Sensitivity and specificity of risk factors for degeneration of IPMNs

Measurement of high-grade dysplasia or invasive cancer on the histological analysis of the surgical specimen

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients with a Branch Duct, Main Duct or mixed IPMNs operated at the Nancy CHRU between September 2009 and October 2021, adults and without legal protection measures

Exclusion Criteria

* IPMNs not operated
* Pancreatic cancer without IPMNs
* Patients whose state of health contraindicates pancreatic surgery
* Non-adult patient
* Patients under legal protection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Jean-Baptiste CHEVAUX

PH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Baptiste JC CHEVAUX

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Regional Universitaire de Nancy

Locations

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Jean-Baptiste CHEVAUX

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Remy RF FONTANIE

Role: CONTACT

0616297216

Marion MS SCHAEFER

Role: CONTACT

0642743330

Facility Contacts

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Jean Baptiste JC CHEVAUX

Role: primary

0677066140

Remy RF FONTANIE

Role: backup

0616297216

Other Identifiers

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2021PI064

Identifier Type: -

Identifier Source: org_study_id

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