Role of EUS in Detection of Liver Metastasis

NCT04509492 | Completed

• 1 other identifier: Ethical comittee N91/2020
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Liver metastasis may not be detected by CT and MRI due to their small size while they can be detected by EUS. Also, EUS-FNA has a great impact in improving the diagnostic accuracy of EUS. Objectives: To assess the feasibility of EUS in the detection of occult small hepatic focal lesions at the time of primary tumor staging, not seen by CT or MRI.

Conditions

Liver Metastases; Pancreatic Neoplasms

Keywords

EUS; occult metastases

Outcome Measures

Primary Outcomes (1)

• The number of patients with occult hepatic metastasis missed by CT or MRI during staging of pancreatic and GI malignancy.

  pre-operative assessment of pancreatic neoplasms includes EUS examination to assess operability depending on the size, relation to blood vessels and metastasis. sometimes we found liver metastases missed during imaging evaluation by MRI and CT that could change the whole plan, so we aimed to study how frequent occult liver metastasis with be discovered during EUS staging of pancreatic cancer

  6 months

Interventions

Endoscopic ultrasound ( EUS ) DIAGNOSTIC_TEST

\- EUS will be done to all patients. During EUS examination the liver will be examined thoroughly to detect hepatic focal lesions with possible EUS-FNA of any detected lesions. All EUS examination will being done by EUS linear array Echoendoscope, Pentax EG-3870UTK attached to Hitachi Avius US machine under Propofol deep sedation

Also known as: EUS-FNA ( fine needle aspiration )

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

400 pt , both male and female above 12 years All patients diagnosed with either pancreatic or gastrointestinal tumors and have undergone a CT scan of the abdomen with contrast or MRI before being referred for EUS for staging

You may qualify if:

• All patients diagnosed with either pancreatic or gastrointestinal tumors and have undergone a CT scan of the abdomen with contrast or MRI before being referred for EUS for staging

You may not qualify if:

• Patients are younger than 12 years. Patients who previously known to have HCC. Patient unfit for deep sedation by Propofol injection. Patients with bleeding disorders contraindicating EUS-FNA

Sponsors & Collaborators

• Mahmoud Wahba: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

Related Publications (7)

• Bhatia V, Hijioka S, Hara K, Mizuno N, Imaoka H, Yamao K. Endoscopic ultrasound description of liver segmentation and anatomy. Dig Endosc. 2014 May;26(3):482-90. doi: 10.1111/den.12216. Epub 2013 Dec 19.

  PMID: 24355092 BACKGROUND

• Prachayakul V, Aswakul P, Kachintorn U. EUS guided fine needle aspiration cytology of liver nodules suspicious for malignancy: yields, complications and impact on management. J Med Assoc Thai. 2012 Feb;95 Suppl 2:S56-60.

  PMID: 22574530 BACKGROUND

• Saraireh HA, Bilal M, Singh S. Role of endoscopic ultrasound in liver disease: Where do we stand in 2017? World J Hepatol. 2017 Aug 28;9(24):1013-1021. doi: 10.4254/wjh.v9.i24.1013.

  PMID: 28932347 BACKGROUND

• Eloubeidi MA, Khan AS, Luz LP, Linder A, Moreira DM, Crowe DR, Eltoum IA. Combined use of EUS-guided FNA and immunocytochemical stains discloses metastatic and unusual diseases in the evaluation of mediastinal lymphadenopathy of unknown etiology. Ann Thorac Med. 2012 Apr;7(2):84-91. doi: 10.4103/1817-1737.94527.

  PMID: 22558013 BACKGROUND

• Wong JYY, Kongkam P, Ho KY. Training in endoscopic ultrasonography: An Asian perspective. Dig Endosc. 2017 May;29(4):512-516. doi: 10.1111/den.12802. Epub 2017 Feb 8.

  PMID: 28066947 RESULT

• Kim E, Telford JJ. Advances in endoscopic ultrasound, part 2: Therapy. Can J Gastroenterol. 2009 Oct;23(10):691-8. doi: 10.1155/2009/786212. No abstract available.

  PMID: 19826645 RESULT

• Srinivasan I, Tang SJ, Vilmann AS, Menachery J, Vilmann P. Hepatic applications of endoscopic ultrasound: Current status and future directions. World J Gastroenterol. 2015 Nov 28;21(44):12544-57. doi: 10.3748/wjg.v21.i44.12544.

  PMID: 26640331 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endosonography; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Punctures

Study Officials

• hussein Okasha, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of medicine division of gastroenterology

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 12, 2020
• Study Start: October 1, 2020
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

EG (1)