Liver CirrhosisNCT02335580
Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis
An observational study of Liver Cirrhosis and Portal Vein, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%. Current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic patients remains under debate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis, Portal Vein, Venous Thrombosis
- What is being tested?
- Somatostatin and its analogs and Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 475 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population should be the patients with a diagnosis with liver cirrhosis who were admitted to the Department of Gastroenterology of General Hospital of Shenyang Military Area.
Who may be able to join
- A diagnosis of liver cirrhosis.
- Patients should be diagnosed with high-risk varices endoscopically, or a prior history of variceal bleeding, or an episode of acute variceal bleeding.
- Patients agreed to undergo endoscopy to evaluate the presence and severity of varices.
- Patients agreed to undergo contrast-enhanced CT scans to evaluate the portal vein patency. But if an abdominal contrast-enhanced CT scans was performed within 3 months after admission, it was not necessarily repeated.
Who cannot join
- Non-cirrhotic patients.
- Malignancy.
- Contrast-enhanced CT scans were neither feasible nor available.
- Severe cardiopulmonary diseases.
- Severe infectious diseases.
- Pregnant or breastfeeding.
- Allergic to contrast agents.
- Poor adherence.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, General Hospital of Shenyang Military Area
Shenyang, Liaoning, 110840
About this study
Official title: Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Cohort Study
The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%. Current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic patients remains under debate. Considering that PVT potentially elevates the portal pressure and thereby increase the risk of variceal bleeding, we focus on the patients with high-risk varices and variceal bleeding as the study population. Thus, the main goals are to analyze the effect of PVT on the incidence of first variceal bleeding in patients without any prior bleeding history but with high-risk varices, the incidence of recurrent variceal bleeding in patients with a history of variceal bleeding, and the treatment failure rate of variceal bleeding in patients with acute variceal bleeding. Certainly, the survival is also observed in all patients.
- Conditions
- Liver Cirrhosis, Portal Vein, Venous Thrombosis, Varicose Veins, Hemorrhage
- Being tested
- Somatostatin and its analogs, Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injection
- Keywords
- Prognosis
- Medical subject headings
- Liver Cirrhosis, Venous Thrombosis, Varicose Veins, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatostatin and its analogsDrug
Somatostatin and/or octreotide will be intravenously infused.
Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injectionProcedure or surgery
Endoscopic sclerotherapy, endoscopic variceal ligation, and/or endoscopic tissue glue injection will be performed based on the endoscopists' choice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 6-24 months
First bleeding
As for the patients without any prior history of bleeding but with high-risk varices, the first bleeding was observed.
Measured: 0-24 months
Recurrent bleeding
As for the patients with a prior history of bleeding, the recurrent bleeding was observed.
Measured: 0-24 months
Treatment failure rate of acute variceal bleeding
As for the patients with acute variceal bleeding, the 5-day treatment failure of acute bleeding was observed.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2022
- Study completionDec 2022
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 CirrhosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335580
- Sponsor's protocol ID
- PVT-LC Prognosis
- Status last verified
- Feb 2023
- First submitted
- 7 Jan 2015
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Qi X, Han G, Fan D. Management of portal vein thrombosis in liver cirrhosis. Nat Rev Gastroenterol Hepatol. 2014 Jul;11(7):435-46. doi: 10.1038/nrgastro.2014.36. Epub 2014 Apr 1.
PubMed 24686266Qi X, Yang Z, Fan D. Spontaneous resolution of portal vein thrombosis in cirrhosis: where do we stand, and where will we go? Saudi J Gastroenterol. 2014 Sep-Oct;20(5):265-6. doi: 10.4103/1319-3767.141680. No abstract available.
PubMed 25253359Qi X, Wang J, Chen H, Han G, Fan D. Nonmalignant partial portal vein thrombosis in liver cirrhosis: to treat or not to treat? Radiology. 2013 Mar;266(3):994-5. doi: 10.1148/radiol.12122259. No abstract available.
PubMed 23431230Qi X, Han G, He C, Yin Z, Guo W, Niu J, Fan D. CT features of non-malignant portal vein thrombosis: a pictorial review. Clin Res Hepatol Gastroenterol. 2012 Dec;36(6):561-8. doi: 10.1016/j.clinre.2012.05.021. Epub 2012 Aug 9.
PubMed 22883835Qi X, Bai M, Yang Z, Yuan S, Zhang C, Han G, Fan D. Occlusive portal vein thrombosis as a new marker of decompensated cirrhosis. Med Hypotheses. 2011 Apr;76(4):522-6. doi: 10.1016/j.mehy.2010.12.007. Epub 2011 Jan 8.
PubMed 21216538Qi X, Han G, Wang J, Wu K, Fan D. Degree of portal vein thrombosis. Hepatology. 2010 Mar;51(3):1089-90. doi: 10.1002/hep.23397. No abstract available.
PubMed 19957371Qi X, Han G, Bai M, Fan D. Stage of portal vein thrombosis. J Hepatol. 2011 May;54(5):1080-2; author reply 1082-3. doi: 10.1016/j.jhep.2010.10.034. Epub 2010 Dec 5. No abstract available.
PubMed 21145872
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT02335580
- Acronym / sponsor ID
- PVT-LC Prognosis
- Conditions
- Liver Cirrhosis, Portal Vein, Venous Thrombosis, Varicose Veins, Hemorrhage
- Keywords
- Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 12 Jan 2015 (estimated)
- 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.
The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%. Current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic patients remains under debate. Considering that PVT potentially elevates the portal pressure and thereby increase the risk of variceal bleeding, we focus on the patients with high-risk varices and variceal bleeding as the study population. Thus, the main goals are to analyze the effect of PVT on the incidence of first variceal bleeding in patients without any prior bleeding history but with high-risk varices, the incidence of recurrent variceal bleeding in patients with a history of variceal bleeding, and the treatment failure rate of variceal bleeding in patients with acute variceal bleeding. Certainly, the survival is also observed in all patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population should be the patients with a diagnosis with liver cirrhosis who were admitted to the Department of Gastroenterology of General Hospital of Shenyang Military Area.
Key inclusion criteria (4 listed)
- A diagnosis of liver cirrhosis.
- Patients should be diagnosed with high-risk varices endoscopically, or a prior history of variceal bleeding, or an episode of acute variceal bleeding.
- Patients agreed to undergo endoscopy to evaluate the presence and severity of varices.
- Patients agreed to undergo contrast-enhanced CT scans to evaluate the portal vein patency. But if an abdominal contrast-enhanced CT scans was performed within 3 months after admission, it was not necessarily repeated.
Key exclusion criteria (8 listed)
- Non-cirrhotic patients.
- Malignancy.
- Contrast-enhanced CT scans were neither feasible nor available.
- Severe cardiopulmonary diseases.
- Severe infectious diseases.
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 |
|---|---|---|
| Somatostatin and its analogsSomatostatin and/or octreotide will be intravenously infused. | Drug | – |
| Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injectionEndoscopic sclerotherapy, endoscopic variceal ligation, and/or endoscopic tissue glue injection will be performed based on the endoscopists' choice. | Procedure or surgery | – |
Primary outcome
Overall survival
Time frame: 6-24 months
First bleeding
Time frame: 0-24 months
As for the patients without any prior history of bleeding but with high-risk varices, the first bleeding was observed.
Recurrent bleeding
Time frame: 0-24 months
As for the patients with a prior history of bleeding, the recurrent bleeding was observed.
Treatment failure rate of acute variceal bleeding
Time frame: 5 days
As for the patients with acute variceal bleeding, the 5-day treatment failure of acute bleeding was observed.
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 24 Feb 2023.
- Background: PubMed 24686266Qi X, Han G, Fan D. Management of portal vein thrombosis in liver cirrhosis. Nat Rev Gastroenterol Hepatol. 2014 Jul;11(7):435-46. doi: 10.1038/nrgastro.2014.36. Epub 2014 Apr 1.
- Background: PubMed 25253359Qi X, Yang Z, Fan D. Spontaneous resolution of portal vein thrombosis in cirrhosis: where do we stand, and where will we go? Saudi J Gastroenterol. 2014 Sep-Oct;20(5):265-6. doi: 10.4103/1319-3767.141680. No abstract available.
- Background: PubMed 23431230Qi X, Wang J, Chen H, Han G, Fan D. Nonmalignant partial portal vein thrombosis in liver cirrhosis: to treat or not to treat? Radiology. 2013 Mar;266(3):994-5. doi: 10.1148/radiol.12122259. No abstract available.
- Background: PubMed 22883835Qi X, Han G, He C, Yin Z, Guo W, Niu J, Fan D. CT features of non-malignant portal vein thrombosis: a pictorial review. Clin Res Hepatol Gastroenterol. 2012 Dec;36(6):561-8. doi: 10.1016/j.clinre.2012.05.021. Epub 2012 Aug 9.
- Background: PubMed 21216538Qi X, Bai M, Yang Z, Yuan S, Zhang C, Han G, Fan D. Occlusive portal vein thrombosis as a new marker of decompensated cirrhosis. Med Hypotheses. 2011 Apr;76(4):522-6. doi: 10.1016/j.mehy.2010.12.007. Epub 2011 Jan 8.
- Background: PubMed 19957371Qi X, Han G, Wang J, Wu K, Fan D. Degree of portal vein thrombosis. Hepatology. 2010 Mar;51(3):1089-90. doi: 10.1002/hep.23397. No abstract available.
- Background: PubMed 21145872Qi X, Han G, Bai M, Fan D. Stage of portal vein thrombosis. J Hepatol. 2011 May;54(5):1080-2; author reply 1082-3. doi: 10.1016/j.jhep.2010.10.034. Epub 2010 Dec 5. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cirrhosis and Portal Vein, run by General Hospital of Shenyang Military Region at 1 site in China.
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 4 inclusion and 8 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 24 Feb 2023. 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 China. 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?
Overall survival (time frame: 6-24 months). The study lists 4 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 NCT02335580, 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 24 Feb 2023.