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Pancreatic CancerNCT04148755

The Accurateness of Endoscopic Ultrasound Elastography in the Guidance of EUS-FNA in Solid Pancreatic Lesions

An observational study of Pancreatic Cancer, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the role and effectiveness of EUS elastography as the guidance for direction of the site of fine needle aspirate (FNA) for tissue acquisition of solid pancreatic lesions Read more about this study

Who is it for?
Any age
Conditions the study is for
Pancreatic Cancer
What is being tested?
Endoscopic ultrasound guided fine needle aspirate
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteEgypt
Study dates
29 Oct 2019to 30 Oct 2021
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients who are indicated for EUS evaluation of pancreatic lesions

Who may be able to join

  • 1 -All patients presented for EUS evaluation of solid pancreatic lesions 2-Accidentally discovered solid pancreatic lesions during EUS examination for any other cause

Who cannot join

  • Uncontrolled coagulopathy
  • Patients refused to enroll to the study.
  • Patients with cystic pancreatic lesions.

Trial locations and contacts

1 site in 1 country.

Rasha Mo Mahmoud, Assistant lecturer contact

0201005322434 ext. AssiutU

rasha.ahmed@med.aun.edu.eg

Egypt1 site, 1 recruiting
  • Assiut University

    Asyut, 751175

    Rasha Mo Mahmoud, Master degree, 01005322434 ext. Ghu, rasha.ahmed@med.aun.edu.eg

    Assiut Un Hospital, Professor, 01005322434 ext. Gh, rasha.ahmed@med.aun.edu.eg

    Recruiting

Other trials in Egypt

About this study

To evaluate the role and effectiveness of EUS elastography as the guidance for direction of the site of fine needle aspirate (FNA) for tissue acquisition of solid pancreatic lesions

Read the detailed description

Pancreatic cancer is one of the leading causes of cancer-related death. It has a poor 5-year survival rate of around8-9%. This is primarily because of most patients with pancreatic adenocarcinoma progress to either metastatic or locally advanced disease while in the asymptomatic phase. However, if pancreatic cancer is detected in the early stage (i.e., less than 2.0 cm), it has a relatively better prognosis.

Traditionally, transabdominal ultrasound or computed tomography CT scanning are used to diagnose pancreatic lesions. However, transabdominal ultrasound is limited because it cannot be used to visualize the entire pancreas due to intervening fat or air. Endoscopic ultrasonography (EUS) is currently an essential emerging tool for the work-up of pancreaticobiliary neoplasms. (EUS) is an ultrasound (US) technique in which the tip of the endoscope is equipped with a high-frequency transducer. High-resolution images of the pancreas can be obtained through the esophagus, stomach, and duodenum, without the disrupting effects of intervening gas, fat, and bone. EUS is now regarded as the most sensitive imaging modality for the detection of even a very small pancreatic lesion. Endoscopic ultrasound (EUS) elastography is a novel non-invasive technique that is used for the evaluation of pancreatic tissue which was first reported in 2006 and can be used for distinguishing benign from malignant pancreatic masses. Therefore, accurate detection of small cancers is important for reducing the mortality rate from pancreatic cancer. The equipment can be coupled with conventional EUS without the need for additional devices. There are two types of EUS elastography, strain and shear wave. Strain elastography estimates the stiffness and elasticity of the target tissue by measuring the degree of strain produced in response to compression. Shear wave elastography involves the emission of focused ultrasound from the probe to the target tissue, the so-called 'acoustic radiation force impulse' (ARFI), and the stiffness of the target tissue is then estimated by measuring the propagation speed of the shear wave. Only strain elastography is so far available for EUS. EUS elastography is used to characterize pancreatic masses and lymph node metastases of pancreatic cancer as well as to judge the severity of chronic pancreatitis with the evaluation of lesion elasticity EUS-guided fine needle aspiration (EUS-FNA) has been generally used for the sampling of pancreatic tissues since it was first reported in 1992. In general, 19G-25G caliber needles are inserted under EUS guidance for the pathological diagnosis of pancreatic cancer and lymph nodes and/or hepatic focal lesions. The overall complication rate of EUS-FNA is including complications such as pain, bleeding, and pancreatitis.

EUS FNA remains the gold standard in diagnosing pancreatic lesions and pancreatic cancer via tissue acquisition with a sensitivity of 80-85% and a specificity of 100 %, however, the diagnostic accuracy of EUS guided FNA is limited and EUS FNA can be associated with risks and complications. Many pre-procedural and procedural considerations must be assessed before performing EUS guided FNA. The location of the lesion, lack of adequate visualization, lack of experience of the endoscopist, lack of onsite pathology, and lack of adequate sampling are all limitations in diagnostic yield. False negatives can also occur in up to 40% of cases. In our multi-center experience, we are going to focus on the use of EUS elastography to direct the site of fine-needle aspiration in tissue acquisition of solid pancreatic lesions and its effect on the accuracy of diagnosis and detection of solid pancreatic lesions.

Being tested
Endoscopic ultrasound guided fine needle aspirate
Keywords
EUS. Elastography, FNA
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic ultrasound guided fine needle aspirateProcedure or surgery

    All patients are going to have an EUS guided elastography with FNA of solid pancreatic lesions

Study groups in NCT04148755
Study groupRoleWhat they receive
Elastography guided FNAThose patients are going to have EUS elastography guided FNA
Receives: Procedure: Endoscopic ultrasound guided fine needle aspirate
EUS. FNAFrom records we are going to compare them with patients who had EUS without elastography guided FNA
Receives: Procedure: Endoscopic ultrasound guided fine needle aspirate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of Accurate diagnosis of pancreatic lesions

    Measured: 2 years

  2. The incidence and frequency of FNA passes

    Measured: 2year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2019
  2. Study start29 Oct 2019
  3. Primary completion30 Mar 2021 (estimated)
  4. Study completion30 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04148755
Sponsor's protocol ID
Elastography-FNA
Status last verified
Oct 2019
First submitted
30 Oct 2019
Last updated
4 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • McGuigan A, Kelly P, Turkington RC, Jones C, Coleman HG, McCain RS. Pancreatic cancer: A review of clinical diagnosis, epidemiology, treatment and outcomes. World J Gastroenterol. 2018 Nov 21;24(43):4846-4861. doi: 10.3748/wjg.v24.i43.4846.

    PubMed 30487695
  • Hara K, Yamao K, Mizuno N, Hijioka S, Sawaki A, Tajika M, Kawai H, Kondo S, Shimizu Y, Niwa Y. Interventional endoscopic ultrasonography for pancreatic cancer. World J Clin Oncol. 2011 Feb 10;2(2):108-14. doi: 10.5306/wjco.v2.i2.108.

    PubMed 21603319
  • Prado-Costa R, Rebelo J, Monteiro-Barroso J, Preto AS. Ultrasound elastography: compression elastography and shear-wave elastography in the assessment of tendon injury. Insights Imaging. 2018 Oct;9(5):791-814. doi: 10.1007/s13244-018-0642-1. Epub 2018 Aug 17.

    PubMed 30120723
  • Jani BS, Rzouq F, Saligram S, Lim D, Rastogi A, Bonino J, Olyaee M. Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Lesions: A Systematic Review of Technical and Procedural Variables. N Am J Med Sci. 2016 Jan;8(1):1-11. doi: 10.4103/1947-2714.175185.

    PubMed 27011940
  • Jafri M, Sachdev AH, Khanna L, Gress FG. The Role of Real Time Endoscopic Ultrasound Guided Elastography for Targeting EUS-FNA of Suspicious Pancreatic Masses: A Review of the Literature and A Single Center Experience. JOP. 2016 Sep;17(5):516-524.

    PubMed 28912670
  • Weston BR, Bhutani MS. Optimizing Diagnostic Yield for EUS-Guided Sampling of Solid Pancreatic Lesions: A Technical Review. Gastroenterol Hepatol (N Y). 2013 Jun;9(6):352-63.

    PubMed 23935542

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Cancer, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rasha Mo Mahmoud, Assistant lecturer (0201005322434 ext. AssiutU, rasha.ahmed@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of Accurate diagnosis of pancreatic lesions (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04148755, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.

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