Peritoneal Dialysis Catheters for the Treatment of Refractory Ascites

Summary

One complication of liver disease is the buildup of fluid within the belly. This is known as ascites. Patients who have ascites have a decreased appetite, pain, nausea and shortness of breath. Ascites is typically treated with medications, however when that does not work, patients need a procedure where a needle is inserted in the belly every few weeks to drain the excess fluid. About 2 in 5 patients with ascites from liver failure can get kidney disease from their worsening liver function or from the drainage of fluid with needles. Once patients have both advanced liver disease and kidney disease, their chance of dying largely increases. The present study will be the first of its kind to study a new technique to treat ascites. Investigators are planning to place a tube in a patient's belly to drain the excessive amounts of fluid. This technique is similar to how one type of dialysis is done to treat patients with kidney failure. This study is set as a pilot investigation in order to determine the feasibility of doing a larger, randomized clinical trial investigating the use of this novel technique. Importantly, advanced liver disease patients are at high risk to develop kidney disease, and therefore are an important group to focus on. Investigators believe that this technique will prevent or slow the development of kidney disease in liver failure patients, and improve their quality of life, far more than the current available treatments.

Timeline

Start

2017-01

Primary completion

2018-05

Completion

2019-02

Publications

• Background Senousy BE, Draganov PV. Evaluation and management of patients with refractory ascites. World J Gastroenterol. 2009 Jan 7;15(1):67-80. doi: 10.3748/wjg.15.67.
• Background Planas R, Montoliu S, Balleste B, Rivera M, Miquel M, Masnou H, Galeras JA, Gimenez MD, Santos J, Cirera I, Morillas RM, Coll S, Sola R. Natural history of patients hospitalized for management of cirrhotic ascites. Clin Gastroenterol Hepatol. 2006 Nov;4(11):1385-94. doi: 10.1016/j.cgh.2006.08.007.
• Background Singhal S, Baikati KK, Jabbour II, Anand S. Management of refractory ascites. Am J Ther. 2012 Mar;19(2):121-32. doi: 10.1097/MJT.0b013e3181ff7a8b.
• Background Runyon BA; AASLD Practice Guidelines Committee. Management of adult patients with ascites due to cirrhosis: an update. Hepatology. 2009 Jun;49(6):2087-107. doi: 10.1002/hep.22853. No abstract available.
• Background Van Thiel DH, Moore CM, Garcia M, George M, Nadir A. Continuous peritoneal drainage of large-volume ascites. Dig Dis Sci. 2011 Sep;56(9):2723-7. doi: 10.1007/s10620-011-1792-x. Epub 2011 Jul 7.
• Background Peltekian KM, Wong F, Liu PP, Logan AG, Sherman M, Blendis LM. Cardiovascular, renal, and neurohumoral responses to single large-volume paracentesis in patients with cirrhosis and diuretic-resistant ascites. Am J Gastroenterol. 1997 Mar;92(3):394-9.
• Background Lungren MP, Kim CY, Stewart JK, Smith TP, Miller MJ. Tunneled peritoneal drainage catheter placement for refractory ascites: single-center experience in 188 patients. J Vasc Interv Radiol. 2013 Sep;24(9):1303-8. doi: 10.1016/j.jvir.2013.05.042. Epub 2013 Jul 19.
• Background Savin MA, Kirsch MJ, Romano WJ, Wang SK, Arpasi PJ, Mazon CD. Peritoneal ports for treatment of intractable ascites. J Vasc Interv Radiol. 2005 Mar;16(3):363-8. doi: 10.1097/01.RVI.0000147082.05392.2B.
• Background Tapping CR, Ling L, Razack A. PleurX drain use in the management of malignant ascites: safety, complications, long-term patency and factors predictive of success. Br J Radiol. 2012 May;85(1013):623-8. doi: 10.1259/bjr/24538524. Epub 2011 Mar 22.
• Background Barnett TD, Rubins J. Placement of a permanent tunneled peritoneal drainage catheter for palliation of malignant ascites: a simplified percutaneous approach. J Vasc Interv Radiol. 2002 Apr;13(4):379-83. doi: 10.1016/s1051-0443(07)61740-0.
• Background Belfort MA, Stevens PJ, DeHaek K, Soeters R, Krige JE. A new approach to the management of malignant ascites; a permanently implanted abdominal drain. Eur J Surg Oncol. 1990 Feb;16(1):47-53.
• Background Monsky WL, Yoneda KY, MacMillan J, Deutsch LS, Dong P, Hourigan H, Schwartz Y, Magee S, Duffield C, Boak T, Cernilia J. Peritoneal and pleural ports for management of refractory ascites and pleural effusions: assessment of impact on patient quality of life and hospice/home nursing care. J Palliat Med. 2009 Sep;12(9):811-7. doi: 10.1089/jpm.2009.0061.
• Background Fleming ND, Alvarez-Secord A, Von Gruenigen V, Miller MJ, Abernethy AP. Indwelling catheters for the management of refractory malignant ascites: a systematic literature overview and retrospective chart review. J Pain Symptom Manage. 2009 Sep;38(3):341-9. doi: 10.1016/j.jpainsymman.2008.09.008. Epub 2009 Mar 28.
• Background Nessim SJ, Bargman JM, Jassal SV, Oliver MJ, Na Y, Perl J. The impact of transfer from hemodialysis on peritoneal dialysis technique survival. Perit Dial Int. 2015 May-Jun;35(3):297-305. doi: 10.3747/pdi.2013.00147. Epub 2013 Dec 1.
• Background Wong F. Management of ascites in cirrhosis. J Gastroenterol Hepatol. 2012 Jan;27(1):11-20. doi: 10.1111/j.1440-1746.2011.06925.x.

Drugs

Indications