Clinical trial NCT02335580: Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis
Official title: Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Portal Vein
Venous Thrombosis
Varicose Veins
Hemorrhage
Keywords: Prognosis
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 475
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 6-24 months
measure: First bleeding
timeFrame: 0-24 months
measure: Recurrent bleeding
timeFrame: 0-24 months
measure: Treatment failure rate of acute variceal bleeding
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Gastroenterology, General Hospital of Shenyang Military Area
state: Liaoning
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.