Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

NCT ID: NCT02335580

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

475 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis Portal Vein Venous Thrombosis Varicose Veins Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Somatostatin and its analogs

Somatostatin and/or octreotide will be intravenously infused.

Intervention Type DRUG

Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injection

Endoscopic sclerotherapy, endoscopic variceal ligation, and/or endoscopic tissue glue injection will be performed based on the endoscopists' choice.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. A diagnosis of liver cirrhosis.
2. Patients should be diagnosed with high-risk varices endoscopically, or a prior history of variceal bleeding, or an episode of acute variceal bleeding.
3. Patients agreed to undergo endoscopy to evaluate the presence and severity of varices.
4. 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.

Exclusion Criteria

1. Non-cirrhotic patients.
2. Malignancy.
3. Contrast-enhanced CT scans were neither feasible nor available.
4. Severe cardiopulmonary diseases.
5. Severe infectious diseases.
6. Pregnant or breastfeeding.
7. Allergic to contrast agents.
8. Poor adherence.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Shenyang Military Region

OTHER

Sponsor Role lead

Responsible Party

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Xingshun Qi

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Gastroenterology, General Hospital of Shenyang Military Area

Shenyang, Liaoning, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 24686266 (View on PubMed)

Qi 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.

Reference Type BACKGROUND
PMID: 25253359 (View on PubMed)

Qi 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.

Reference Type BACKGROUND
PMID: 23431230 (View on PubMed)

Qi 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.

Reference Type BACKGROUND
PMID: 22883835 (View on PubMed)

Qi 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.

Reference Type BACKGROUND
PMID: 21216538 (View on PubMed)

Qi 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.

Reference Type BACKGROUND
PMID: 19957371 (View on PubMed)

Qi 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.

Reference Type BACKGROUND
PMID: 21145872 (View on PubMed)

Other Identifiers

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PVT-LC Prognosis

Identifier Type: -

Identifier Source: org_study_id

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