Liver MetastasesNCT04509492
Role of EUS in Detection of Liver Metastasis
An observational study of Liver Metastases and Pancreatic Neoplasms, run by Mahmoud Wahba at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Liver Metastases, Pancreatic Neoplasms
- What is being tested?
- Endoscopic ultrasound ( EUS )
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 21 Apr 2021
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of EUS in Detection of Liver Metastasis Not Seen by CT or MRI During Staging of Pancreatic, Gastrointestinal, and Thoracic Malignancies.
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.
Read the detailed description
Endoscopic ultrasound (EUS) was used firstly in 1980s as a diagnostic imaging technique for pancreatic lesions. It has the ability to detect the histological layers of the gastrointestinal (GI) tract wall as well as the periluminal structures.
EUS has been used to perform FNA from lesions that are difficult to access by conventional methods. EUS has the advantage of using both ultrasound and endoscopy to give the exact diagnostic features of the GI tract. The use of EUS was not limited to visualization only, but also in obtaining tissue biopsy for diagnostic purpose through EUS guided fine needle aspiration (FNA), and it has played a major role in revolutionizing the diagnosis of focal hepatic lesions as it is a minimally invasive procedure.
Abdominal imaging [CT, magnetic resonance imaging (MRI), and transabdominal ultrasonography (USG)] are the diagnostic tests of choice to detect hepatic lesions suspicious of metastasis.Unfortunately, these modalities are limited in their ability to detect hepatic lesions less than 1 cm.
In addition, although rare, percutaneous FNA for suspected metastatic lesions carries the risk of implantation metastasis. Although unable to completely visualize the entirety of the liver, EUS can detect small hepatic lesions that may be otherwise missed by conventional imaging. EUS can delineate detailed anatomy of the liver from the trans-gastric and trans-duodenal routes with the exception of the right posterior segments.
The prospect to obtain precise, ultrasound-guided biopsies of possible metastatic liver lesions can drastically alter the therapeutic conduct.
This, combined with limited adverse events, makes EUS an excellent modality to allow staging in malignant conditions. Due to the vicinity of the transducer to the liver, EUS provides detailed images of the liver segments and its vascular structures.
Based on the premise that EUS is more sensitive for the detection of small hepatic lesions then CT/MRI, Singh et al. proved that EUS was superior to CT scan (98% vs 92%, respectively) in diagnostic accuracy in its ability to detect the number of metastatic lesions in the liver and correctly diagnose the nature of the lesions .(Singh P etal.,2009) Endoscopic ultrasonography (EUS) has become an indispensable method for diagnosis and therapeutic procedures in gastroenterology and as experience with this technique is growing, new indications for EUS continue to emerge.
(Saraireh HA .,2017) Furthermore, the use of on-site cytopathology interpretation has further improved the diagnostic yield of EUS-FNA by helping to ensure that the samples obtained are representative of the target organ and adequate for diagnostic purposes.
Objectives: To assess the feasibility of EUS in detection of occult small hepatic focal lesions at the time of primary tumor staging, not seen by CT or MRI
All the patients will be subjected to:
- Thorough history talking including;
- Age
- Sex
- Comorbidity
- Clinical general and local abdominal examination
- Abdominal US \& CT abdomen
- laboratory investigations:
- 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.
Data collection tool:
Data including study design, participant demographics, stage and type of pancreatic and GI malignancy will be extracted and recorded on electronic data collection sheet. Data will be pooled for various arms in trials: Individual data for each outcome were entered into the Comprehensive analysis. Pooled effects with 95%CI will be reported. Data will be analyzed separately for each arm.
- Conditions
- Liver Metastases, Pancreatic Neoplasms
- Being tested
- Endoscopic ultrasound ( EUS )
- Keywords
- EUS, occult metastases
- 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 ( EUS )Diagnostic test
Also called EUS-FNA ( fine needle aspiration )
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Oct 2020
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Wahba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Wahba, Cairo University
- Investigators
- hussein Okasha, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509492
- Sponsor's protocol ID
- Ethical comittee N91/2020
- Status last verified
- May 2021
- First submitted
- 9 Aug 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24355092Prachayakul 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.
PubMed 22574530Saraireh 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.
PubMed 28932347Eloubeidi 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.
PubMed 22558013Wong 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.
PubMed 28066947Kim 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.
PubMed 19826645Srinivasan 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.
PubMed 26640331
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of EUS in Detection of Liver Metastasis Not Seen by CT or MRI During Staging of Pancreatic, Gastrointestinal, and Thoracic Malignancies.
- ClinicalTrials.gov ID
- NCT04509492
- Acronym / sponsor ID
- Ethical comittee N91/2020
- Conditions
- Liver Metastases, Pancreatic Neoplasms
- Keywords
- EUS, occult metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Mahmoud WahbaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Endoscopic ultrasound (EUS) was used firstly in 1980s as a diagnostic imaging technique for pancreatic lesions. It has the ability to detect the histological layers of the gastrointestinal (GI) tract wall as well as the periluminal structures.
EUS has been used to perform FNA from lesions that are difficult to access by conventional methods. EUS has the advantage of using both ultrasound and endoscopy to give the exact diagnostic features of the GI tract. The use of EUS was not limited to visualization only, but also in obtaining tissue biopsy for diagnostic purpose through EUS guided fine needle aspiration (FNA), and it has played a major role in revolutionizing the diagnosis of focal hepatic lesions as it is a minimally invasive procedure.
Abdominal imaging [CT, magnetic resonance imaging (MRI), and transabdominal ultrasonography (USG)] are the diagnostic tests of choice to detect hepatic lesions suspicious of metastasis.Unfortunately, these modalities are limited in their ability to detect hepatic lesions less than 1 cm.
In addition, although rare, percutaneous FNA for suspected metastatic lesions carries the risk of implantation metastasis. Although unable to completely visualize the entirety of the liver, EUS can detect small hepatic lesions that may be otherwise missed by conventional imaging. EUS can delineate detailed anatomy of the liver from the trans-gastric and trans-duodenal routes with the exception of the right posterior segments.
The prospect to obtain precise, ultrasound-guided biopsies of possible metastatic liver lesions can drastically alter the therapeutic conduct.
This, combined with limited adverse events, makes EUS an excellent modality to allow staging in malignant conditions. Due to the vicinity of the transducer to the liver, EUS provides detailed images of the liver segments and its vascular structures.
Based on the premise that EUS is more sensitive for the detection of small hepatic lesions then CT/MRI, Singh et al. proved that EUS was superior to CT scan (98% vs 92%, respectively) in diagnostic accuracy in its ability to detect the number of metastatic lesions in the liver and correctly diagnose the nature of the lesions .(Singh P etal.,2009) Endoscopic ultrasonography (EUS) has become an indispensable method for diagnosis and therapeutic procedures in gastroenterology and as experience with this technique is growing, new indications for EUS continue to emerge.
(Saraireh HA .,2017) Furthermore, the use of on-site cytopathology interpretation has further improved the diagnostic yield of EUS-FNA by helping to ensure that the samples obtained are representative of the target organ and adequate for diagnostic purposes.
Objectives: To assess the feasibility of EUS in detection of occult small hepatic focal lesions at the time of primary tumor staging, not seen by CT or MRI
All the patients will be subjected to:
- Thorough history talking including;
- Age
- Sex
- Comorbidity
- Clinical general and local abdominal examination
- Abdominal US \& CT abdomen
- laboratory investigations:
- 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.
Data collection tool:
Data including study design, participant demographics, stage and type of pancreatic and GI malignancy will be extracted and recorded on electronic data collection sheet. Data will be pooled for various arms in trials: Individual data for each outcome were entered into the Comprehensive analysis. Pooled effects with 95%CI will be reported. Data will be analyzed separately for each arm.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound ( EUS )Also: EUS-FNA ( fine needle aspiration )- 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 | Diagnostic test | – |
Primary outcome
The number of patients with occult hepatic metastasis missed by CT or MRI during staging of pancreatic and GI malignancy.
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Background: PubMed 24355092Bhatia 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.
- Background: PubMed 22574530Prachayakul 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.
- Background: PubMed 28932347Saraireh 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.
- Background: PubMed 22558013Eloubeidi 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.
- Results publication: PubMed 28066947Wong 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.
- Results publication: PubMed 19826645Kim 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.
- Results publication: PubMed 26640331Srinivasan 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.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Metastases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hussein Okasha, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Metastases and Pancreatic Neoplasms, run by Mahmoud Wahba 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 1 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: finished, as of the sponsor's last update on 18 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with occult hepatic metastasis missed by CT or MRI during staging of pancreatic and GI malignancy. (time frame: 6 months). 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 NCT04509492, which also lists 7 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 18 May 2021.