Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

NCT02335580 | Completed

• 1 other identifier: PVT-LC Prognosis
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Portal Vein; Venous Thrombosis; Varicose Veins; Hemorrhage

Keywords

Prognosis

Outcome Measures

Primary Outcomes (4)

• Overall survival

  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.

  0-24 months

• Recurrent bleeding

  As for the patients with a prior history of bleeding, the recurrent bleeding was observed.

  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.

  5 days

Interventions

Somatostatin and its analogs DRUG

Somatostatin and/or octreotide will be intravenously infused.

Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injection PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Gastroenterology, General Hospital of Shenyang Military Area

Shenyang, Liaoning, 110840, China

Location

Related Publications (7)

• 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.

  PMID: 24686266 BACKGROUND

• 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.

  PMID: 25253359 BACKGROUND

• 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.

  PMID: 23431230 BACKGROUND

• 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.

  PMID: 22883835 BACKGROUND

• 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.

  PMID: 21216538 BACKGROUND

• 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.

  PMID: 19957371 BACKGROUND

• 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.

  PMID: 21145872 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Venous Thrombosis; Varicose Veins; Hemorrhage

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 12, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

CN (1)