Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335580
• Other study ID #: PVT-LC Prognosis
• Status: Completed
• Start date: December 2014
• Est. completion date: December 2022

Study information

• Verified date: February 2023
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Hemorrhage
• Liver Cirrhosis
• Portal Vein
• Thrombosis
• Varicose Veins
• Venous Thrombosis

Intervention

Drug:
• Somatostatin and its analogs
Somatostatin and/or octreotide will be intravenously infused.

Procedure:
• 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.

Locations

Country	Name	City	State
China	Department of Gastroenterology, General Hospital of Shenyang Military Area	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		6-24 months
Primary	First bleeding	As for the patients without any prior history of bleeding but with high-risk varices, the first bleeding was observed.	0-24 months
Primary	Recurrent bleeding	As for the patients with a prior history of bleeding, the recurrent bleeding was observed.	0-24 months
Primary	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.	5 days