Clinical Trial: Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparative Study of Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism
Brief Summary:
The aim of this study is to compare microwave thermal coagulation and partial splenic embolization in the management of hypersplenism in patients with cirrhosis.
This study will be conducted on 40 patients with liver cirrhosis associated with splenomegaly and hypersplenism. The study will be done at the National Hepatology and Tropical Medicine Research Institute.
Detailed Summary:
Liver cirrhosis or portal hypertension is frequently associated with congestive splenomegaly resulting in hypersplenism.
Hypersplenism can be defined as anemia, leukopenia, thrombocytopenia, or a combination of these resulting from excessive, splenic sequestration or pooling of blood cells, usually associated with clinical splenomegaly and always ameliorated by splenectomy.
Partial splenic embolization (PSE), which was first performed by Spigos et al in 1979, has been considered first-line therapy for hypersplenism in many institutions, and has been proposed as an effective alternative to splenectomy for improving peripheral blood cell counts. However, PSE is associated with many complications, including intermittent fever, abdominal pain, nausea, vomiting, post-embolization syndrome, splenic abscess, splenic rupture, pneumonia, refractory ascites, pleural effusion and gastrointestinal bleeding. To ensure a sustained and long-term increase in platelet and leucocytic counts, the splenic infarction rate needs to be greater than 50%. Thus, severe complications can ensue.
Thermal ablation methods using different energy sources, such as radiofrequency (RF), microwave (MW), or laser, were developed rapidly as minimally invasive techniques for the eradication of local tumor tissue within solid organs. There have been reports of the use of radiofrequency to ablate normal spleen, splenic injury, and splenomegaly.
Radiofrequency Ablation (RFA) had comparable efficacy and a better safety than PSE in the treatment of hypersplenism in patients with post hepatitis c cirrhosis.
MW ablation performed either laparoscopically or percutaneously is a safe, effective, and minimally invasive techn
Sponsor: Tanta University
Current Primary Outcome: Percentage of participants with improvement of hypersplenism after microwave thermal coagulation of the spleen compared with partial splenic embolization. [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Tanta University
Dates:
Date Received: September 26, 2014
Date Started: August 2014
Date Completion: February 2015
Last Updated: October 9, 2014
Last Verified: October 2014
