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Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism

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ClinicalTrials.gov Identifier: NCT02261584
Recruitment Status : Unknown
Verified October 2014 by Ibrahim Shebl, Tanta University.
Recruitment status was:  Recruiting
First Posted : October 10, 2014
Last Update Posted : October 10, 2014
Sponsor:
Information provided by (Responsible Party):
Ibrahim Shebl, Tanta University

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.


Condition or disease Intervention/treatment Phase
Hypersplenism Device: Microwave Thermal Coagulation Device: Partial Splenic Embolization Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism
Study Start Date : August 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spleen Diseases

Arm Intervention/treatment
Experimental: Microwave Thermal Coagulation
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 cell (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.
Device: Microwave Thermal Coagulation
Microwave thermal coagulation of splenic parenchyma.
Other Name: Microwave

Experimental: Partial Splenic Embolization Catheter
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% (8). Thus, severe complications can ensue.
Device: Partial Splenic Embolization
Femoral artery approach will be used for splenic artery catheterization with the tip of the catheter always well advanced selectively into the splenic artery. Embolizing agent will be injected in small increments. Arteriography in between divided doses will be done to document the extent of devascularization.
Other Name: PSE




Primary Outcome Measures :
  1. Percentage of participants with improvement of hypersplenism after microwave thermal coagulation of the spleen compared with partial splenic embolization. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261584


Contacts
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Contact: Asem A Elfert, MD +20-122-437-8188 asem1967@yahoo.com

Locations
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Egypt
National Hepatology and Tropical Medicine Research Institute Recruiting
Cairo, Egypt
Contact: Asem A Elfert, MD    +20-122-437-8188    asem1967@yahoo.com   
Principal Investigator: Asem A Elfert, MD         
Sub-Investigator: Fat-heya E Assel, MD         
Sub-Investigator: Mohamed M Elkassas         
Sub-Investigator: Islam S Ismail         
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Asem A Elfert, MD Tanta Faculty of Medicine, Professor
Study Director: Fat-heya E Assel, MD` Tanta Faculty of Medicine, Professor
Study Director: Mohamed M Elkassas Dr.
Study Director: Islam S Ismail Dr.

Publications of Results:
Wasfi et al., Prospective randomized controlled study of Radiofrequency Ablation and Partial Splenic Embolization in the Treatment of Hypersplenism in patients with post-hepatitis C cirrhosis. AASLD poster DDW 2014, Chicago, USA

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Responsible Party: Ibrahim Shebl, Dr., Tanta University
ClinicalTrials.gov Identifier: NCT02261584     History of Changes
Other Study ID Numbers: Microwave vs PSE
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: October 10, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Hypersplenism
Splenic Diseases
Lymphatic Diseases