Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism

Hypersplenism Clinical Trial

Official title:

Comparative Study of Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02261584
• Other study ID #: Microwave vs PSE
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2014
• Last updated: October 9, 2014
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2014
• Source: Tanta University
• Contact: Asem A Elfert, MD
• Phone: +20-122-437-8188
• Email: asem1967[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersplenism

Intervention

Device:
• Microwave Thermal Coagulation
Microwave thermal coagulation of splenic parenchyma.
• 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.

Locations

Country	Name	City	State
Egypt	National Hepatology and Tropical Medicine Research Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

Crooks V, Waller S, Smith T, Hahn TJ. The use of the Karnofsky Performance Scale in determining outcomes and risk in geriatric outpatients. J Gerontol. 1991 Jul;46(4):M139-44. — View Citation

Felekouras E, Kontos M, Pissanou T, Pikoulis E, Drakos E, Papalambros E, Diamantis T, Bastounis E. A new spleen-preserving technique using radiofrequency ablation technology. J Trauma. 2004 Dec;57(6):1225-9. — View Citation

Hayashi H, Beppu T, Okabe K, Masuda T, Okabe H, Baba H. Risk factors for complications after partial splenic embolization for liver cirrhosis. Br J Surg. 2008 Jun;95(6):744-50. doi: 10.1002/bjs.6081. — View Citation

Liang P, Gao Y, Zhang H, Yu X, Wang Y, Duan Y, Shi W. Microwave ablation in the spleen for treatment of secondary hypersplenism: a preliminary study. AJR Am J Roentgenol. 2011 Mar;196(3):692-6. doi: 10.2214/AJR.10.4193. — View Citation

Liu Q, Ma K, He Z, Dong J, Hua X, Huang X, Qiao L. Radiofrequency ablation for hypersplenism in patients with liver cirrhosis: a pilot study. J Gastrointest Surg. 2005 May-Jun;9(5):648-57. — View Citation

Matsuoka T, Yamamoto A, Okuma T, Oyama Y, Nakamura K, Inoue Y. CT-guided percutaneous radiofrequency ablation of spleen: a preliminary study. AJR Am J Roentgenol. 2007 Apr;188(4):1044-6. — View Citation

N'Kontchou G, Seror O, Bourcier V, Mohand D, Ajavon Y, Castera L, Grando-Lemaire V, Ganne-Carrie N, Sellier N, Trinchet JC, Beaugrand M. Partial splenic embolization in patients with cirrhosis: efficacy, tolerance and long-term outcome in 32 patients. Eur — View Citation

Pursnani KG, Sillin LF, Kaplan DS. Effect of transjugular intrahepatic portosystemic shunt on secondary hypersplenism. Am J Surg. 1997 Mar;173(3):169-73. — View Citation

Rasekhi AR, Naderifar M, Bagheri MH, Shahriari M, Foroutan H, Karimi M, Nabavizadeh SA. Radiofrequency ablation of the spleen in patients with thalassemia intermedia: a pilot study. AJR Am J Roentgenol. 2009 May;192(5):1425-9. doi: 10.2214/AJR.08.1382. — View Citation

Sangro B, Bilbao I, Herrero I, Corella C, Longo J, Beloqui O, Ruiz J, Zozaya JM, Quiroga J, Prieto J. Partial splenic embolization for the treatment of hypersplenism in cirrhosis. Hepatology. 1993 Aug;18(2):309-14. — View Citation

Spigos DG, Jonasson O, Mozes M, Capek V. Partial splenic embolization in the treatment of hypersplenism. AJR Am J Roentgenol. 1979 May;132(5):777-82. — View Citation

Tajiri T, Onda M, Yoshida H, Mamada Y, Taniai N, Kumazaki T. Long-term hematological and biochemical effects of partial splenic embolization in hepatic cirrhosis. Hepatogastroenterology. 2002 Sep-Oct;49(47):1445-8. — View Citation

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

Zhu K, Meng X, Qian J, Huang M, Li Z, Guan S, Jiang Z, Shan H. Partial splenic embolization for hypersplenism in cirrhosis: a long-term outcome in 62 patients. Dig Liver Dis. 2009 Jun;41(6):411-6. doi: 10.1016/j.dld.2008.10.005. Epub 2008 Dec 12. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with improvement of hypersplenism after microwave thermal coagulation of the spleen compared with partial splenic embolization.		6 months	Yes