Clinical trial NCT02261584: Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism
Official title: Comparative Study of Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypersplenism
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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 technique for the management of hypersplenism in patients with liver cirrhosis. It may significantly increase platelet count and white blood cells (WBC) count and improve hepatic blood supply with fewer complications. Ablating more than 40% of the splenic parenchyma may yield better long term results. This method may provide a new and promising minimally invasive alternative for treating hypersplenism.

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.

All patients will be subjected to thorough history taking, full clinical, lab, ultrasound/doppler, and upper endoscopic examination. Diagnosis has been based on peripheral blood count and confirmed with bone marrow examination.

Preoperative antibiotics will be given and correction of bleeding tendency with plasma and platelet transfusion will be done as required to get a prothrombin concentration more than 65% and platelet count more than 100,000.

Eligibility criteria: Inclusion Criteria:

* Liver Cirrhosis
* Hypersplenism

Exclusion Criteria:

* Patients with bad performance scale.
* Patients with hepatic encephalopathy and tense ascites.
* Patient with active esophageal variceal bleeding .
* Patients with hypocellular bone marrow (BM).
* Patients with renal failure.

Primary outcomes:
measure: Percentage of participants with improvement of hypersplenism after microwave thermal coagulation of the spleen compared with partial splenic embolization.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Hepatology and Tropical Medicine Research Institute
Study officials:
affiliation: Tanta Faculty of Medicine, Professor
name: Asem A Elfert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta Faculty of Medicine, Professor
name: Fat-heya E Assel, MD'
role: STUDY_DIRECTOR
affiliation: Dr.
name: Mohamed M Elkassas
role: STUDY_DIRECTOR
affiliation: Dr.
name: Islam S Ismail
role: STUDY_DIRECTOR
References:
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