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Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism

Primary Purpose

Hypersplenism

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Microwave Thermal Coagulation
Partial Splenic Embolization
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersplenism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Hepatology and Tropical Medicine Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Microwave Thermal Coagulation

Partial Splenic Embolization Catheter

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of participants with improvement of hypersplenism after microwave thermal coagulation of the spleen compared with partial splenic embolization.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2014
Last Updated
October 9, 2014
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02261584
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersplenism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microwave Thermal Coagulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Partial Splenic Embolization Catheter
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Microwave Thermal Coagulation
Other Intervention Name(s)
Microwave
Intervention Description
Microwave thermal coagulation of splenic parenchyma.
Intervention Type
Device
Intervention Name(s)
Partial Splenic Embolization
Other Intervention Name(s)
PSE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of participants with improvement of hypersplenism after microwave thermal coagulation of the spleen compared with partial splenic embolization.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asem A Elfert, MD
Phone
+20-122-437-8188
Email
asem1967@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
Organizational Affiliation
Tanta Faculty of Medicine, Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fat-heya E Assel, MD'
Organizational Affiliation
Tanta Faculty of Medicine, Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed M Elkassas
Organizational Affiliation
Dr.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Islam S Ismail
Organizational Affiliation
Dr.
Official's Role
Study Director
Facility Information:
Facility Name
National Hepatology and Tropical Medicine Research Institute
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
Phone
+20-122-437-8188
Email
asem1967@yahoo.com
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
First Name & Middle Initial & Last Name & Degree
Fat-heya E Assel, MD
First Name & Middle Initial & Last Name & Degree
Mohamed M Elkassas
First Name & Middle Initial & Last Name & Degree
Islam S Ismail

12. IPD Sharing Statement

Citations:
PubMed Identifier
9124620
Citation
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Results Reference
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PubMed Identifier
107745
Citation
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PubMed Identifier
12239963
Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism

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