NCT03749941

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
18.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

18.7 years

First QC Date

November 18, 2018

Last Update Submit

November 19, 2018

Conditions

Solid Pseudopapillary Tumor

Keywords

EUS-FNA

Outcome Measures

Primary Outcomes (1)

  • Recurrence after primary tumor resection

    Recurrence after primary tumor resection confirmed during follow up

    through study completion, an average of 43 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 18, 2018

First Posted

November 21, 2018

Study Start

January 1, 2000

Primary Completion

September 15, 2018

Study Completion

September 15, 2018

Last Updated

November 21, 2018

Record last verified: 2018-11