Portal Vein ThrombosisNCT03902678
Role of EUS Guided FNA of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma
A study testing EUS guided fine needle aspiration of portal vein thrombus in people with Portal Vein Thrombosis, run by Mansoura University at 1 site in Egypt.
Trial summary
Since not every portal vein thrombus (PVT) in a patient with hepatocellular carcinoma (HCC) is a tumor thrombus, since the nature of the thrombus will ultimately determine the course of treatment, and since PVT may be even the initial sign of an undetected HCC, every effort should be made to distinguish between a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Vein Thrombosis
- What is being tested?
- EUS guided fine needle aspiration of portal vein thrombus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 11 May 2017to 11 Jul 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with liver cirrhosis and PVT which don't fulfill criteria of malignancy by triphasic CT abdomen defined as, (neovascularity of thrombus, arterial enhancement with rapid washout, direct invasion by adjacent hepatic mass and diameter of thrombus more than 23 mm), either :
- With or without hepatic mass
- Undergone local treatment or surgical treatment following a diagnosis of HCC and develop PVT during their follow up.
Who cannot join
- Uncooperative or excessively apprehensive patient
- Anticoagulation treatment or non-substituted coagulopathy (International Normalized Ratio ≥ 1.5, Platelet count ≤ 50.000 cells/mm3, heparin administration at therapeutic doses).
- Inhibition of platelet aggregation by clopidogrel and other thienopyridines.
- Contraindications of sedation (Uncontrolled Diabetes Mellitus, Uncontrolled Thyroid Disorders, Pregnancy, Respiratory Embarrassment, Reactional Drugs like Antidepressants and Anti-anxiety Agents).
- Patients fulfilling criteria of malignancy by triphasic CT on abdomen.
- Extra hepatic metastasis of HCC.
- Child-Pugh classification stage C.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
specialized medical hospital, Mansourah University
Al Mansurah, Dakahlia Governorate, 35516
dina S. eskandere, Master, 01148979995, dinaeskandere@mans.edu.eg
Dina S. Eskandere, Master
About this study
Official title: Role of Endoscopic Ultrasound Guided Fine Needle Aspiration of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma
Since not every portal vein thrombus (PVT) in a patient with hepatocellular carcinoma (HCC) is a tumor thrombus, since the nature of the thrombus will ultimately determine the course of treatment, and since PVT may be even the initial sign of an undetected HCC, every effort should be made to distinguish between a tumor and a non-tumor PVT. In addition, malignant PVT does not always demonstrate neovascularity and/or enhancement, which makes fine needle aspiration (FNA) necessary in order to characterize the nature of the PVT.
Sampling of portal vein thrombus with trans-abdominal ultrasound guidance may lead to erroneous results because of inadvertent inclusion of normal hepatocytes or associated liver masses. Further, potential adverse events of trans-abdominal portal vein sampling include serious biliary and/or vascular injury.
Read more
In contrast to the percutaneous approach, Endoscopic ultrasound (EUS) provides a unique view and access to the main portal vein. From the duodenal bulb and second part of the duodenum, the portal vein can be visualized from the confluence of the splenic and superior mesenteric veins into the porta hepatis. Periportal collateral vessels or cavernous transformation of the portal vein, which commonly are associated with portal vein thrombosis, are also easily and reliably detected by EUS instruments with color Doppler US capability.
With a linear-array echo-endoscope, the portal vein can be punctured easily with a fine needle under direct visualization, while avoiding the adjacent hepatic artery, bile duct, and collateral vessels (if present). Because the approach is not trans-hepatic, it eliminates any need to avoid the primary tumor and any possibility of contaminating the specimen with hepatocytes, as can occur if the needle tracks through the liver parenchyma. Thus, the rate of false-positive diagnoses is likely to be lower with the EUS compared with the percutaneous approach
Read the detailed description
This is a pilot study that include 30 patients with liver cirrhosis and portal vein thrombus which don't fulfill the criteria of malignancy by imaging technique. The patients involved in the study were and will be admitted to Specialized Medical Hospital, Mansoura University Hospitals.
Study end-points:
- 24 months from the start of the research (cases will be collected over 18 months).
Methods:
Patients will be included in this study will be subjected to the following:
І. The study will be explained to all participants in the study, and an informed written consent will be obtained from them before starting the study.
ІІ. Medical history:
Detailed history was taken with stress on:
- Signs of cachexia (unintentional weight loss, progressive muscle wasting, and a loss of appetite)
- Low grade fever
- Recent onset fatigue
- Abdominal pain
- Dyspepsia
- Hematemesis and melena
- Back ache
ІІІ. Full clinical examination with special stress on:
- Vital signs including: pulse, arterial blood pressure, temperature, respiratory rate.
- Abdominal Lumps and/or tenderness
IV. Laboratory investigations:
Complete blood count, International Normalized Ratio, Liver enzymes, Serum albumin, Serum bilirubin and Serum creatinine.
- Radiology: Abdominal ultrasound for initial assessment, Abdominal CT (Contrast Enhanced) (Number of HCC nodules if present, diameter of largest HCC nodule in centimeters, nature of PVT, presence of abdominal metastases if present ), Non contrast CT chest to exclude pulmonary metastasis, Bone survey for indicated or complaining cases.
VI. EUS-FNA:
EUS-FNA will be performed in standard fashion. Under EUS guidance, the main, left and right portal veins will be identified. After verifying flow signal by Doppler, a 25-gauge EUS-FNA needle will be advanced from the duodenal bulb or second part of the duodenum into the portal vein, 1-2 passes through portal vein thrombus will be taken to ensure adequate cellularity for histopathology. The puncture site will be monitored under EUS for complications.
Study outcomes:
Histopathology of biopsies taken from bland portal vein thrombus which diagnosed by triphasic CT abdomen to evaluate the possibility of malignant PVT that was not discovered by imaging technique (Abdominal ultrasound and triphasic abdominal CT ).
- Conditions
- Portal Vein Thrombosis
- Being tested
- EUS guided fine needle aspiration of portal vein thrombus
- Keywords
- EUS, FNA, PVT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS guided fine needle aspiration of portal vein thrombusProcedure or surgery
endoscopic ultrasound guided fine needle aspiration of portal vein thrombus which did not fulfill criteria of malignancy by imaging technique
| Study group | Role | What they receive |
|---|---|---|
| EUS - FNA for benign PVT by imaging | Experimental | Intervention: Procedure/Surgery: EUS guided fine needle aspiration of portal vein thrombus Receives: Procedure: EUS guided fine needle aspiration of portal vein thrombus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with bland portal vein thrombosis diagnosed by triphasic abdominal CT who are proven to have malignant cells by histopathology obtained via EUS-guided FNA
Histopathology of biopsies taken from bland portal vein thrombus which diagnosed by triphasic CT abdomen to evaluate the possibility of malignant PVT that was not discovered by imaging technique (Abdominal ultrasound and triphasic abdominal CT )
Measured: 3 days up to 2 weeks
Percentage of patients with portal vein thrombosis who underwent EUS guided FNA and had complications as a result of the invasive maneuver
assessment of safety of the procedure ( The patients admitted and the new ones will be admitted to specialized medical hospital for 24 h after the procedure to exclude the possibility of bleeding at puncture site, risk of biliary peritonitis, and extravasation from the site of the thrombus.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start11 May 2017
- Primary completion11 May 2019 (estimated)
- Study completion11 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Portal Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Use of histopathology obtained from endoscopic ultrasound -fine needle aspiration of portal vein thrombus for identification of malignant thrombus which did not fulfill criteria of malignancy by abdominal ultrasound and triphasic abdominal CT
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdy H. Atwa, Professor, Study chair, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902678
- Sponsor's protocol ID
- MD /17.06.69
- Status last verified
- Apr 2019
- First submitted
- 26 Jan 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Catalano OA, Choy G, Zhu A, Hahn PF, Sahani DV. Differentiation of malignant thrombus from bland thrombus of the portal vein in patients with hepatocellular carcinoma: application of diffusion-weighted MR imaging. Radiology. 2010 Jan;254(1):154-62. doi: 10.1148/radiol.09090304.
PubMed 20032150Handa P, Crowther M, Douketis JD. Portal vein thrombosis: a clinician-oriented and practical review. Clin Appl Thromb Hemost. 2014 Jul;20(5):498-506. doi: 10.1177/1076029612473515. Epub 2013 Jan 29.
PubMed 23364162Lai R, Stephens V, Bardales R. Diagnosis and staging of hepatocellular carcinoma by EUS-FNA of a portal vein thrombus. Gastrointest Endosc. 2004 Apr;59(4):574-7. doi: 10.1016/s0016-5107(04)00007-0. No abstract available.
PubMed 15044903Tarantino L, Ambrosino P, Di Minno MN. Contrast-enhanced ultrasound in differentiating malignant from benign portal vein thrombosis in hepatocellular carcinoma. World J Gastroenterol. 2015 Aug 28;21(32):9457-60. doi: 10.3748/wjg.v21.i32.9457.
PubMed 26327753ASGE Technology Committee; Trikudanathan G, Pannala R, Bhutani MS, Melson J, Navaneethan U, Parsi MA, Thosani N, Trindade AJ, Watson RR, Maple JT. EUS-guided portal vein interventions. Gastrointest Endosc. 2017 May;85(5):883-888. doi: 10.1016/j.gie.2017.02.019. Epub 2017 Mar 18. No abstract available.
PubMed 28320514Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6.
PubMed 26146089Kayar Y, Turkdogan KA, Baysal B, Unver N, Danalioglu A, Senturk H. EUS-guided FNA of a portal vein thrombus in hepatocellular carcinoma. Pan Afr Med J. 2015 Jun 3;21:86. doi: 10.11604/pamj.2015.21.86.6991. eCollection 2015.
PubMed 26491529Michael H, Lenza C, Gupta M, Katz DS. Endoscopic Ultrasound -guided Fine-Needle Aspiration of a Portal Vein Thrombus to Aid in the Diagnosis and Staging of Hepatocellular Carcinoma. Gastroenterol Hepatol (N Y). 2011 Feb;7(2):124-9. No abstract available.
PubMed 21475421Rustagi T, Gleeson FC, Chari ST, Abu Dayyeh BK, Farnell MB, Iyer PG, Kendrick ML, Pearson RK, Petersen BT, Rajan E, Topazian MD, Truty MJ, Vege SS, Wang KK, Levy MJ. Remote malignant intravascular thrombi: EUS-guided FNA diagnosis and impact on cancer staging. Gastrointest Endosc. 2017 Jul;86(1):150-155. doi: 10.1016/j.gie.2016.10.025. Epub 2016 Oct 20.
PubMed 27773725
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endoscopic Ultrasound Guided Fine Needle Aspiration of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03902678
- Acronym / sponsor ID
- MD /17.06.69
- Conditions
- Portal Vein Thrombosis
- Keywords
- EUS, FNA, PVT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 11 May 2019 (estimated)
- Study completion
- 11 Jul 2019 (estimated)
- First posted
- 4 Apr 2019 (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.
Since not every portal vein thrombus (PVT) in a patient with hepatocellular carcinoma (HCC) is a tumor thrombus, since the nature of the thrombus will ultimately determine the course of treatment, and since PVT may be even the initial sign of an undetected HCC, every effort should be made to distinguish between a tumor and a non-tumor PVT. In addition, malignant PVT does not always demonstrate neovascularity and/or enhancement, which makes fine needle aspiration (FNA) necessary in order to characterize the nature of the PVT.
Sampling of portal vein thrombus with trans-abdominal ultrasound guidance may lead to erroneous results because of inadvertent inclusion of normal hepatocytes or associated liver masses. Further, potential adverse events of trans-abdominal portal vein sampling include serious biliary and/or vascular injury.
In contrast to the percutaneous approach, Endoscopic ultrasound (EUS) provides a unique view and access to the main portal vein. From the duodenal bulb and second part of the duodenum, the portal vein can be visualized from the confluence of the splenic and superior mesenteric veins into the porta hepatis. Periportal collateral vessels or cavernous transformation of the portal vein, which commonly are associated with portal vein thrombosis, are also easily and reliably detected by EUS instruments with color Doppler US capability.
With a linear-array echo-endoscope, the portal vein can be punctured easily with a fine needle under direct visualization, while avoiding the adjacent hepatic artery, bile duct, and collateral vessels (if present). Because the approach is not trans-hepatic, it eliminates any need to avoid the primary tumor and any possibility of contaminating the specimen with hepatocytes, as can occur if the needle tracks through the liver parenchyma. Thus, the rate of false-positive diagnoses is likely to be lower with the EUS compared with the percutaneous approach
Detailed description
This is a pilot study that include 30 patients with liver cirrhosis and portal vein thrombus which don't fulfill the criteria of malignancy by imaging technique. The patients involved in the study were and will be admitted to Specialized Medical Hospital, Mansoura University Hospitals.
Study end-points:
- 24 months from the start of the research (cases will be collected over 18 months).
Methods:
Patients will be included in this study will be subjected to the following:
І. The study will be explained to all participants in the study, and an informed written consent will be obtained from them before starting the study.
ІІ. Medical history:
Detailed history was taken with stress on:
- Signs of cachexia (unintentional weight loss, progressive muscle wasting, and a loss of appetite)
- Low grade fever
- Recent onset fatigue
- Abdominal pain
- Dyspepsia
- Hematemesis and melena
- Back ache
ІІІ. Full clinical examination with special stress on:
- Vital signs including: pulse, arterial blood pressure, temperature, respiratory rate.
- Abdominal Lumps and/or tenderness
IV. Laboratory investigations:
Complete blood count, International Normalized Ratio, Liver enzymes, Serum albumin, Serum bilirubin and Serum creatinine.
- Radiology: Abdominal ultrasound for initial assessment, Abdominal CT (Contrast Enhanced) (Number of HCC nodules if present, diameter of largest HCC nodule in centimeters, nature of PVT, presence of abdominal metastases if present ), Non contrast CT chest to exclude pulmonary metastasis, Bone survey for indicated or complaining cases.
VI. EUS-FNA:
EUS-FNA will be performed in standard fashion. Under EUS guidance, the main, left and right portal veins will be identified. After verifying flow signal by Doppler, a 25-gauge EUS-FNA needle will be advanced from the duodenal bulb or second part of the duodenum into the portal vein, 1-2 passes through portal vein thrombus will be taken to ensure adequate cellularity for histopathology. The puncture site will be monitored under EUS for complications.
Study outcomes:
Histopathology of biopsies taken from bland portal vein thrombus which diagnosed by triphasic CT abdomen to evaluate the possibility of malignant PVT that was not discovered by imaging technique (Abdominal ultrasound and triphasic abdominal CT ).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Use of histopathology obtained from endoscopic ultrasound -fine needle aspiration of portal vein thrombus for identification of malignant thrombus which did not fulfill criteria of malignancy by abdominal ultrasound and triphasic abdominal CT
| Arm | Type | Receives |
|---|---|---|
| EUS - FNA for benign PVT by imaging | Experimental | Procedure: EUS guided fine needle aspiration of portal vein thrombusIntervention: Procedure/Surgery: EUS guided fine needle aspiration of portal vein thrombus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with liver cirrhosis and PVT which don't fulfill criteria of malignancy by triphasic CT abdomen defined as, (neovascularity of thrombus, arterial enhancement with rapid washout, direct invasion by adjacent hepatic mass and diameter of thrombus more than 23 mm), either :
- With or without hepatic mass
- Undergone local treatment or surgical treatment following a diagnosis of HCC and develop PVT during their follow up.
Key exclusion criteria (7 listed)
- Uncooperative or excessively apprehensive patient
- Anticoagulation treatment or non-substituted coagulopathy (International Normalized Ratio ≥ 1.5, Platelet count ≤ 50.000 cells/mm3, heparin administration at therapeutic doses).
- Inhibition of platelet aggregation by clopidogrel and other thienopyridines.
- Contraindications of sedation (Uncontrolled Diabetes Mellitus, Uncontrolled Thyroid Disorders, Pregnancy, Respiratory Embarrassment, Reactional Drugs like Antidepressants and Anti-anxiety Agents).
- Patients fulfilling criteria of malignancy by triphasic CT on abdomen.
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 |
|---|---|---|
| EUS guided fine needle aspiration of portal vein thrombusendoscopic ultrasound guided fine needle aspiration of portal vein thrombus which did not fulfill criteria of malignancy by imaging technique | Procedure or surgery | EUS - FNA for benign PVT by imaging |
Primary outcome
Percentage of patients with bland portal vein thrombosis diagnosed by triphasic abdominal CT who are proven to have malignant cells by histopathology obtained via EUS-guided FNA
Time frame: 3 days up to 2 weeks
Histopathology of biopsies taken from bland portal vein thrombus which diagnosed by triphasic CT abdomen to evaluate the possibility of malignant PVT that was not discovered by imaging technique (Abdominal ultrasound and triphasic abdominal CT )
Percentage of patients with portal vein thrombosis who underwent EUS guided FNA and had complications as a result of the invasive maneuver
Time frame: 2 days
assessment of safety of the procedure ( The patients admitted and the new ones will be admitted to specialized medical hospital for 24 h after the procedure to exclude the possibility of bleeding at puncture site, risk of biliary peritonitis, and extravasation from the site of the thrombus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Background: PubMed 20032150Catalano OA, Choy G, Zhu A, Hahn PF, Sahani DV. Differentiation of malignant thrombus from bland thrombus of the portal vein in patients with hepatocellular carcinoma: application of diffusion-weighted MR imaging. Radiology. 2010 Jan;254(1):154-62. doi: 10.1148/radiol.09090304.
- Background: PubMed 23364162Handa P, Crowther M, Douketis JD. Portal vein thrombosis: a clinician-oriented and practical review. Clin Appl Thromb Hemost. 2014 Jul;20(5):498-506. doi: 10.1177/1076029612473515. Epub 2013 Jan 29.
- Background: PubMed 15044903Lai R, Stephens V, Bardales R. Diagnosis and staging of hepatocellular carcinoma by EUS-FNA of a portal vein thrombus. Gastrointest Endosc. 2004 Apr;59(4):574-7. doi: 10.1016/s0016-5107(04)00007-0. No abstract available.
- Background: PubMed 26327753Tarantino L, Ambrosino P, Di Minno MN. Contrast-enhanced ultrasound in differentiating malignant from benign portal vein thrombosis in hepatocellular carcinoma. World J Gastroenterol. 2015 Aug 28;21(32):9457-60. doi: 10.3748/wjg.v21.i32.9457.
- Background: PubMed 28320514ASGE Technology Committee; Trikudanathan G, Pannala R, Bhutani MS, Melson J, Navaneethan U, Parsi MA, Thosani N, Trindade AJ, Watson RR, Maple JT. EUS-guided portal vein interventions. Gastrointest Endosc. 2017 May;85(5):883-888. doi: 10.1016/j.gie.2017.02.019. Epub 2017 Mar 18. No abstract available.
- Background: PubMed 26146089Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6.
- Results publication: PubMed 26491529Kayar Y, Turkdogan KA, Baysal B, Unver N, Danalioglu A, Senturk H. EUS-guided FNA of a portal vein thrombus in hepatocellular carcinoma. Pan Afr Med J. 2015 Jun 3;21:86. doi: 10.11604/pamj.2015.21.86.6991. eCollection 2015.
- Results publication: PubMed 21475421Michael H, Lenza C, Gupta M, Katz DS. Endoscopic Ultrasound -guided Fine-Needle Aspiration of a Portal Vein Thrombus to Aid in the Diagnosis and Staging of Hepatocellular Carcinoma. Gastroenterol Hepatol (N Y). 2011 Feb;7(2):124-9. No abstract available.
- Results publication: PubMed 27773725Rustagi T, Gleeson FC, Chari ST, Abu Dayyeh BK, Farnell MB, Iyer PG, Kendrick ML, Pearson RK, Petersen BT, Rajan E, Topazian MD, Truty MJ, Vege SS, Wang KK, Levy MJ. Remote malignant intravascular thrombi: EUS-guided FNA diagnosis and impact on cancer staging. Gastrointest Endosc. 2017 Jul;86(1):150-155. doi: 10.1016/j.gie.2016.10.025. Epub 2016 Oct 20.
- paper proved that benign portal vein thrombus by triphasic CT may be truly malignant by the histopathology but the researchers here used different inclusion and exclusion criteria. They obtained samples from cirrhotic patients onlyLink provided by the sponsor.
- case study proved that benign portal vein thrombus by radiology is truly malignant by histopathologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Magdy H. Atwa, Professor study chair
Faculty of Medicine, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS guided fine needle aspiration of portal vein thrombus in people with Portal Vein Thrombosis, run by Mansoura 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 3 inclusion and 7 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 Apr 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 Dina S. Eskandere (01148979995, dinaeskandere@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with bland portal vein thrombosis diagnosed by triphasic abdominal CT who are proven to have malignant cells by histopathology obtained via EUS-guided FNA (time frame: 3 days up to 2 weeks). 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 NCT03902678, which also lists 9 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 Apr 2019.