The majority of patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, which is favored by an imbalance between portal venous inflow and a diminished hepatic volume. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest as it could be used temporarily during the early postoperative course. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease. We aimed to evaluate the impact of somatostatin postoperative infusion on the incidence of ascites following hepatectomy by laparotomy for HCC in patients with underlying liver disease.
The SOMAPROTECT study is a multicenter randomized double-blind placebo controlled phase III trial comparing two arms of patients with underlying liver disease undergoing hepatectomy for HCC by open approach. All patients will have primary abdominal drainage before closure. Patients in the experimental arm will receive a postoperative intravenous infusion of somatostatin during 6 days. Patients in the control group will receive a placebo infusion for the same duration. The primary endpoint will be the presence or absence of postoperative ascites occurring during the 90-day postoperative course, defined as ≥500 ml/24 h of fluid in the drains during at least 3 days or any ascites requiring an invasive procedure comprising percutaneous puncture or drainage. Secondary endpoints will be duration and total volume of ascites, postoperative 90-day mortality and morbidity, liver failure, acute renal failure, length of stay in intensive care unit and hospital stay. The total number of patients to be enrolled was calculated to be 152.
Postoperative ascites remains a major issue after hepatectomy for HCC as it is associated with increased morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. This study represents the first randomized controlled trial to assess the benefits of somatostatin on the risk of postoperative ascites after surgery for HCC.
NCT02799212 (ClinicalTrials.gov identifier). Registered prior to conducting the research on 9 June 2016.
Yamashita Y-I, Ikeda T, Kurihara T, Yoshida Y, Takeishi K, Itoh S, et al. Long-term favorable surgical results of laparoscopic hepatic resection for hepatocellular carcinoma in patients with cirrhosis: a single-center experience over a 10-year period. J Am Coll Surg. 2014;219:1117–23. CrossRefPubMed
Sato Y, Kobayashi T, Nakatsuka H, Yamamoto S, Oya H, Watanabe T, et al. Splenic arterial ligation prevents liver injury after a major hepatectomy by a reduction of surplus portal hypertension in hepatocellular carcinoma patients with cirrhosis. Hepatogastroenterology. 2001;48:831–5. PubMed
Ozden I, Kara M, Pinarbasi B, Salmaslioglu A, Yavru A, Kaymakoglu S, et al. Somatostatin and propranolol to treat small-for-size syndrome that occurred despite splenic artery ligation. Exp Clin Transplant. 2007;5:686–9. PubMed
Fisher SB, Kneuertz PJ, Dodson RM, Patel SH, Maithel SK, Sarmiento JM, et al. A comparison of right posterior sectorectomy with formal right hepatectomy: a dual-institution study. HPB (Oxford). 2013;15:753–62. CrossRef
Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P. Acute Dialysis quality initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the second international consensus conference of the acute Dialysis quality initiative (ADQI) group. Crit Care. 2004;8:R204–12. CrossRefPubMedPubMedCentral
- Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: a multicenter randomized double-blind controlled trial (SOMAPROTECT)
- BioMed Central
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