UMIN-CTR Clinical Trial

Basic information
Public title	Role of EUS in detection of liver metastasis not seen by CT or MRI
Acronym	EUS; endoscopic ultrasound CT; computed tomography MRI; Magnetic resonance imaging
Scientific Title	Role of EUS in detection of liver metastasis not seen by CT or MRI during staging of pancreatic, gastrointestinal, and thoracic malignancies.
Scientific Title:Acronym	EUS; endoscopic ultrasound CT; computed tomography MRI; Magnetic resonance imaging
Region	Africa

Condition
Condition	recruiting
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to detect the sensitivity of EUS in detection of hepatic occult metastasis compared to CT during staging of pancreatic and GI malignancy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	accurate staging of pancreatic cancer for better management before starting management
Key secondary outcomes	proper evaluation of thoracic malignancy - pre-operative evaluation

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	12 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	All patients diagnosed with either pancreatic or gastrointestinal tumors and have underwent a CT scan of the abdomen with contrast or MRI before being referred for EUS for staging
Key exclusion criteria	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.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Hussein Middle name Last name Okasha
Organization	Cairo university
Division name	faculty of medicine
Zip code	11562
Address	Al-Saray Street, El Manial Cairo
TEL	0201001000502
Email	okaha.hussein@gmail.com

Public contact
Name of contact person	1st name Mahmoud Middle name Last name Wahba
Organization	Cairo university
Division name	faculty of medicine
Zip code	11562
Address	Al-Saray Street, El Manial Cairo
TEL	0201123326663
Homepage URL
Email	mahmoud.wahba@kasralainy.edu.eg

Sponsor
Institute	Cairo university Faculty of medicine
Institute
Department

Funding Source
Organization	Cairo university Faculty of medicine
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Cairo university, faculty of medicine
Address	Kasralainy Street, El Manial Cairo, Egypt
Tel	(202)23682030
Email	pg@kasralainy.edu.eg

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2020 Year 03 Month 15 Day
Date of IRB	2020 Year 04 Month 26 Day
Anticipated trial start date	2020 Year 05 Month 01 Day
Last follow-up date	2020 Year 06 Month 01 Day
Date of closure to data entry	2020 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other

Other related information

All the patients will be subjected to:Thorough history talking including; Age, Sex and Comorbidity Clinical general and local abdominal examination, Abdominal US & CT abdomen,laboratory investigations: a complete blood count (CBC), Prothombin time ,INR, Ceatinine , Urea, Albumin, ALT , AST, Virological test for HIV, HCV and HBV, CA-19-9 and alfa fetoproteins. 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 with be done by EUS linear array Echoendoscope, Pentax EG-3870UTK attached to Hitachi Avius US machine under Propofol deep sedation. The collected data will be organized and statistically analyzed.

Management information
Registered date	2020 Year 08 Month 11 Day
Last modified on	2020 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047246