UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041386 |
|---|---|
| Receipt number | R000047246 |
| Scientific Title | Role of EUS in detection of liver metastasis not seen by CT or MRI during staging of pancreatic, gastrointestinal, and thoracic malignancies. |
| Date of disclosure of the study information | 2020/08/19 |
| Last modified on | 2020/08/19 06:15:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mahmoud.wahba@kasralainy.edu.eg
Sponsor or person
Institute
Cairo university
Faculty of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047246
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
