NCT07424456

Brief Summary

evaluate the relationship between triphasic CT and EUS findings and the characterization of pancreatic lesions.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Feb 2026

Status
not yet recruiting

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 Progress23%
Feb 2026Apr 2027

First Submitted

Initial submission to the registry

February 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 1, 2026

Last Update Submit

February 13, 2026

Conditions

EUS Guided BiopsyCT ScanPancreatic Lesions Located at the Body or the Tail

Keywords

Triphasic Ct abdomen vs EUS-FNBEUS-FNB

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of triphasic CT compared to EUS-guided biopsy in differentiating benign from malignant pancreatic lesions.

    the diagnostic accuracy of triphasic CT compared to EUS-guided biopsy in differentiating benign and malignant pancreatic lesions, calculated in terms of sensitivity, specificity, PPV, NPV, and overall accuracy, using final histopathological diagnosis as the reference standard.

    one year

Study Arms (2)

Patients assessed by Triphasic CT scan

Triphasic CT scan: Performed using a multidetector CT scanner and CT parameters assessed: Size, shape, and margins of the lesion Enhancement pattern (hypo / iso / hyper-enhancing) Calcifications or cystic components

Diagnostic Test: Full clinical history (pain, jaundice, weight loss, pancreatitis history). Physical examination with focus on abdominal and systemic findings.

Patients assessed by Endoscopic Ultrasound (EUS)&Tissue Sampling

Performed using linear echoendoscope under conscious sedation or general anesthesia EUS-guided sampling Fine-needle aspiration (FNA) or fine-needle biopsy (FNB) using 19G/22G needles. Multiple passes obtained for cytology and histopathology.

Diagnostic Test: Full clinical history (pain, jaundice, weight loss, pancreatitis history). Physical examination with focus on abdominal and systemic findings.

Interventions

Full clinical history (pain, jaundice, weight loss, pancreatitis history). Physical examination with focus on abdominal and systemic findings.DIAGNOSTIC_TEST

Full clinical history (pain, jaundice, weight loss, pancreatitis history). Physical examination with focus on abdominal and systemic findings.

Patients assessed by Endoscopic Ultrasound (EUS)&Tissue SamplingPatients assessed by Triphasic CT scan

Eligibility Criteria

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

Adult patients (age\>18 years) presenting with focal pancreatic lesions detected on initial imaging.

You may qualify if:

  • \*Adult patients (age\>18 years) presenting with focal pancreatic lesions detected on initial imaging.
  • Patients referred for further evaluation by triphasic CT and/or EUS-guided biopsy.
  • Patients able to provide informed consent

You may not qualify if:

  • Previous pancreatic surgery.
  • Known metastatic disease at presentation.
  • Contraindications to contrast-enhanced CT (e.g. severe renal impairment, contrast allergy)
  • Contraindications to EUS or biopsy (e.g., coagulopathy uncorrected, severe cardiopulmonary instability).
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Iglesias Garcia J, Larino Noia J, Dominguez Munoz JE. Endoscopic ultrasound in the diagnosis and staging of pancreatic cancer. Rev Esp Enferm Dig. 2009 Sep;101(9):631-8. doi: 10.4321/s1130-01082009000900006.

    PMID: 19803666BACKGROUND

  • Öztürk B, Ekmen N, et al. The diagnostic role of endoscopic ultrasonography, CT, and MRI in pancreatic cystic lesions. J Clin Med Kaz. 2021;18(4):71-80.

    BACKGROUND

  • Chen J, Sahai AV, et al. Diagnostic accuracy of endoscopic ultrasound-guided fine-needle aspiration in pancreatic tumors. BMC Gastroenterol. 2012;12:125.

    BACKGROUND

  • Chatterjee A, Shah J. Role of Endoscopic Ultrasound in Diagnosis of Pancreatic Ductal Adenocarcinoma. Diagnostics (Basel). 2023 Dec 28;14(1):78. doi: 10.3390/diagnostics14010078.

    PMID: 38201387RESULT

MeSH Terms

Interventions

Pain Measurement

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Ahmed Abdullah Ashmawy, Prof. Dr

CONTACT

01005679880rasharma@aun.edu.eg

Mohamed Mahdy, ProfDr

CONTACT

drmohhakim@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 20, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share