NCT04623749

Brief Summary

We aim to evaluate the role of Ultrasound-guided (USG) fine needle aspiration cytology (FNAC) in diagnosis of pancreatic masses compared to endoscopic ultrasound (EUS) guided fine needle aspiration cytology (FNAC).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Status
unknown

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

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

November 4, 2020

Last Update Submit

June 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by Trans abdominal US-FNAC. diagnostic accuracy

    Percutaneous US guided FNAC technique

    intraopeatve

Secondary Outcomes (1)

  • Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNAC. diagnostic accuracy

    intraoperative

Study Arms (2)

Percutaneous US guided FNAC in pancreatic masses

ACTIVE COMPARATOR
Procedure: US

EUS guided FNAC in pancreatic masses

ACTIVE COMPARATOR
Procedure: EUS

Interventions

USPROCEDURE

Percutaneous Ultrasound guided FNAC

Percutaneous US guided FNAC in pancreatic masses
EUSPROCEDURE

Endoscopic Ultrasound guided FNAC

EUS guided FNAC in pancreatic masses

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in different sex \& age groups with pancreatic masses

You may not qualify if:

  • Any general contraindications for FNAC or EUS in some cases as Coagulopathy with INR \>1.5 or platelet count \<50,000/mmc, Antithrombotic therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.

    PMID: 25559415BACKGROUND
  • Egawa S, Toma H, Ohigashi H, Okusaka T, Nakao A, Hatori T, Maguchi H, Yanagisawa A, Tanaka M. Japan Pancreatic Cancer Registry; 30th year anniversary: Japan Pancreas Society. Pancreas. 2012 Oct;41(7):985-92. doi: 10.1097/MPA.0b013e318258055c.

    PMID: 22750974BACKGROUND

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic Cyst

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCysts

Central Study Contacts

Ola KM Galal, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

June 14, 2021

Record last verified: 2021-06