Safety of EUS-FNA for Pancreatic Solid-Pseudopapillary Neoplasm (SPN) Before Surgical Resection: the SPN-GRAPHE Series (SPN-GRAPHE)

November 19, 2018 updated by: KARSENTI, Société Française d'Endoscopie Digestive

Safety of EUS-FNA for Pancreatic Solid-Pseudopapillary Neoplasm (SPN) Before Surgical Resection: An European Multicenter Registry-based Study on 149 Patients

Solid-pseudopapillary neoplasm (SPN) is a rare type of pancreatic neoplasm. A cytopathological diagnosis is often mandatory before performing surgical resection. Endo-ultrasonography with fine needle aspiration (EUS-FNA) improve significantly pre-operative SPN diagnosis accuracy. So far, few EUS-FNA performed for SPN were published, and safety of EUS-FNA for SPN has never been investigated. This retrospective European multicenter case-control study compared the recurrence rate in patients with and without EUS-FNA performed before primary tumor resection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This European multicenter study was conducted in 22 digestive units from the GRAPHE (French taskforce of gastroenterologists working on digestive endoscopy: Groupe de Réflexion et d'Action des Praticiens Hépatogastroentérologues en Endoscopie Digestive), and retrospectively included all patients who have undergone complete resection of their pancreatic SPN from 2000 to 2018. The use of the diagnostic filing software of each unit of cytopathology, endoscopy and digestive surgery allowed the completeness of the prospection in each center.

The data were retrospectively collected by extraction from our medical patient management softwares.

The following data were collected: age, gender, symptoms, tumor size, tumor location (uncus, head, isthmus, body or tail of the pancreas), presence of tumor calcifications, performing of a EUS-FNA for diagnostic purposes before surgical resection, follow-up, and diagnosis of recurrence of the SPN during follow-up. Other data were collected in case of EUS-FNA: path of the needle puncture (transgastric or transduodenal), diameter of the needle, number of passes, immediate EUS-FNA morbidity, and EUS-FNA diagnosis of SPN (certain, probable, false or absent).

Patients with and without initial EUS-FNA were compared and the main criteria of this study was determinate: the presence of recurrence of the SPN during follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This European multicenter study was conducted in 22 digestive units from the GRAPHE (French taskforce of gastroenterologists working on digestive endoscopy: Groupe de Réflexion et d'Action des Praticiens Hépatogastroentérologues en Endoscopie Digestive), and retrospectively included all patients who have undergone complete resection of their pancreatic SPN from 2000 to 2018. The use of the diagnostic filing software of each unit of cytopathology, endoscopy and digestive surgery allowed the completeness of the prospection in each center.

The data were retrospectively collected by extraction from our medical patient management softwares.

Description

Inclusion Criteria:

  • All consecutive patients who have undergone complete resection of their pancreatic SPN were included. Inclusion criterion was the definite diagnosis of SPN on the pathological examination of the complete tumor resection specimen.

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence after primary tumor resection
Time Frame: through study completion, an average of 43 months
Recurrence after primary tumor resection confirmed during follow up
through study completion, an average of 43 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société Française d'Endoscopie Digestive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2000

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-SPN-GRAPHE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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