NCT03740360

Brief Summary

This study evaluates the use of contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) and cyst fluid molecular analysis in the differential diagnosis of pancreatic cysts and the detection of malignancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

October 14, 2018

Last Update Submit

February 20, 2020

Conditions

Pancreatic Cyst

Keywords

Pancreatic cystic neoplasmMolecular analysisMucinous cystic neoplasmSerous cystic neoplasmIntraductal papillary neoplasm

Outcome Measures

Primary Outcomes (1)

  • Mutations in pancreatic cystic neoplasm

    Number and type of mutations that are present on the molecular analysis of premalignant and malignant mucinous cyst.

    Baseline

Secondary Outcomes (4)

  • Comparison between morphological criteria and cyst fluid analysis

    Baseline

  • Increase power diagnosis with contrast-enhanced EUS

    Baseline

  • Security of EUS fine-needle aspiration

    7 days

  • Relation between pancreatic fluid and serum molecular analysis

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with with an imaging diagnosing pancreatic cystic neoplasm, older than 18 years old, that come to our unit during the 18 months of the study without exclusion criteria.

You may qualify if:

  • Indeterminate pancreatic cyst \> 2cm
  • Pancreatic cyst \> 1cm with morphological diagnosis suspicious to be mucinous etiology
  • Suitable for endoscopy

You may not qualify if:

  • Contraindication for endoscopy
  • Active anticoagulant or antiplatelet therapy
  • Thrombocytopenia or coagulopathy in the absence of its correction prior to the procedure
  • Abscence of informed consent
  • Extrapancreatic cyst
  • Known pancreatic pseudocyst

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pancreatic cyst fluid and blood samples.

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2018

First Posted

November 14, 2018

Study Start

June 1, 2017

Primary Completion

December 31, 2018

Study Completion

October 31, 2019

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)