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

Solid Pseudopapillary Tumor Clinical Trial

— SPN-GRAPHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749941
• Other study ID #: 2018-SPN-GRAPHE
• Status: Completed
• Start date: January 1, 2000
• Est. completion date: September 15, 2018

Study information

• Verified date: November 2018
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: September 15, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Neoplasms
• Solid Pseudopapillary Tumor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence after primary tumor resection	Recurrence after primary tumor resection confirmed during follow up	through study completion, an average of 43 months