Skip to main content
OpenTrials
Completed

NCT Number: NCT03749941

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solid Pseudopapillary Tumor

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recurrence after primary tumor resection

    Time frame: through study completion, an average of 43 months

    Recurrence after primary tumor resection confirmed during follow up

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

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

Acronym: SPN-GRAPHE

Important dates

Study start
2000
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2018
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.