Microwave Ablation and Partial Splenic Embolization in the Management of Hypersplenism

NCT02261584 | Unknown DMC

• 1 other identifier: Microwave vs PSE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypersplenism

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (2)

Microwave Thermal Coagulation

EXPERIMENTAL

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

Partial Splenic Embolization Catheter

EXPERIMENTAL

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

Interventions

Microwave Thermal Coagulation DEVICE

Microwave thermal coagulation of splenic parenchyma.

Also known as: Microwave

Microwave Thermal Coagulation

Partial Splenic Embolization DEVICE

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.

Also known as: PSE

Partial Splenic Embolization Catheter

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver Cirrhosis
• Hypersplenism

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

National Hepatology and Tropical Medicine Research Institute

Cairo, Cairo Governorate, Egypt

RECRUITING

Related Publications (14)

• Pursnani KG, Sillin LF, Kaplan DS. Effect of transjugular intrahepatic portosystemic shunt on secondary hypersplenism. Am J Surg. 1997 Mar;173(3):169-73. doi: 10.1016/s0002-9610(97)00006-8.

  PMID: 9124620 RESULT

• 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. doi: 10.2214/ajr.132.5.777.

  PMID: 107745 RESULT

• 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.

  PMID: 12239963 RESULT

• 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.

  PMID: 8340060 RESULT

• 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 J Gastroenterol Hepatol. 2005 Feb;17(2):179-84. doi: 10.1097/00042737-200502000-00008.

  PMID: 15674095 RESULT

• 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.

  PMID: 18412294 RESULT

• 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.

  PMID: 19070555 RESULT

• 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. doi: 10.2214/AJR.06.0641.

  PMID: 17377043 RESULT

• 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. doi: 10.1097/01.ta.0000145072.31725.52.

  PMID: 15625453 RESULT

• 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. doi: 10.1016/j.gassur.2004.11.006.

  PMID: 15862259 RESULT

• 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

  RESULT

• 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.

  PMID: 21343515 RESULT

• 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.

  PMID: 19380572 RESULT

• 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. doi: 10.1093/geronj/46.4.m139.

  PMID: 2071835 RESULT

MeSH Terms

Conditions

Hypersplenism

Condition Hierarchy (Ancestors)

Splenic Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Asem A Elfert, MD

  Tanta Faculty of Medicine, Professor

  PRINCIPAL INVESTIGATOR

• Fat-heya E Assel, MD'

  Tanta Faculty of Medicine, Professor

  STUDY DIRECTOR

• Mohamed M Elkassas

  Dr.

  STUDY DIRECTOR

• Islam S Ismail

  Dr.

  STUDY DIRECTOR

Central Study Contacts

Asem A Elfert, MD

CONTACT

+20-122-437-8188; asem1967@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 10, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 10, 2014

Record last verified: 2014-10

Locations

EG (1)