MD1718Z - Method for treating portal vein thrombosis in patients with liver cirrhosis - Google Patents

Abstract

The invention relates to medicine, in particular to vascular surgery and hepatology, and can be used for endovascular treatment of portal vein thrombosis in patients with liver cirrhosis.Summary of the invention consists in that an approach is performed in the subumbilical region with the introduction of an optical device and an approach under the edge of the left costal arch, in the projection of the spleen, with the introduction of a trocar of a diameter of 5 mm, through which, under visualization with the optical device, is introduced a needle with a blunt end, of a length of 15…20 cm and a diameter of 2…3 mm, which is introduced into the parenchyma of the spleen. Then, a contrast agent is introduced through the needle and, under X-ray control, the needle is introduced into an intrasplenic venous branch. Through the said needle is introduced a catheter on a guide, which passes through said venous branch, then through the splenic vein and portal vein, to the area of thrombus localization. After that, the guide is removed and are aspirated thrombotic masses, and through the catheter are introduced thrombolytic and anticoagulant drugs. Then the catheter is pulled up to the level of the hilum of the spleen, and simultaneously with its extraction, two components of fibrin glue are introduced through the formed canal, namely the first component comprises a fibrinogen solution 15…45 mg, and the second component comprises a mixture of thrombin solution 25…100 IU, 10% albumin solution 10…20 ml, aprotinin solution 250…1000 CIE and Ca2+ chloride solution 15…30 µmol, with filling of the canal in the spleen parenchyma. The catheter is then removed and the wound is sutured.

Description

The invention relates to medicine, especially to vascular surgery and hepatology and can be used for the endovascular treatment of portal vein thrombosis in patients with liver cirrhosis.

According to modern pathophysiological concepts, the decisive role in ensuring liver function is attributed to adequate liver perfusion, which depends on the velocity and volume of the portal hemocirculatory flow, the hydrodynamic character of the flow (laminar or turbulent), the portal blood vector, the arterial component of perfusion and the resistance intrahepatic vascular. Among the additional factors that ensure the effectiveness of the portohepatic microcirculation are highlighted the fluidity (viscosity) and oxygenation of the portal venous blood, as well as the integrity of the endothelium of the vessels of the portal basin (Condat B., Valla D. Nonmalignant portal vein thrombosis in adults. In: Nat. Clin. Pract. Gastroenterol., 2006, p. 505-515; Di Cataldo, R., Portal vein thrombosis, 2003, vol. 55, pp. 435-437).

Considerable disturbances of the portal venous flow in the conditions of cirogenic portal hypertension contribute essentially to the tension, deregulation and subsequent decompensation of liver function. Hemocirculation in the portal basin in cirrhotic patients is characterized by hyperdynamic flow, with a reduced velocity, and the increase in vascular resistance, following morphological changes, contributes to the progression of regional chronic venous congestion. The hydrodynamic character of the portal blood flow, in turn, changes from laminar to turbulent, periodically there is a spontaneous inversion of the circulatory vector on the intrahepatic branches and the main portal vein (Kinjo N., Kawanaka H., Akahoshi T. et al. Risk factors for Portal venous thrombosis in patients with cirrhosis and portal hypertension, 2010, vol. 6, Rossi S., Ravetta V al. Contrast-enhanced and color Doppler sonography for the detection of thrombosis of the portal and hepatic venous systems., 2006, vol. 186 (3), p. 763-773.

As a result, the distortion of hemocirculation in the splenoportal vascular territory creates favorable conditions for regional thrombogenesis, which is manifested by the appearance of floating elements in the portal vein and its branches, the formation of adjacent parietal thrombotic masses, which cause partial obstruction of the vascular lumen, with the progression of portal hypertension ( Janssen H. L., Haagsma E. B. et al. In: Gut, 2001, p. 720-724; Kawanaka H. et al. Risk factors for portal venous thrombosis in patients with cirrhosis, 2010, no. 6, Romano F ., Matteo Conti M. Thrombosis of the splenectomy. In: Langenbecks Arch., 2006, p. 169-171.

Over the last few years, more and more publications have appeared in the specialized literature regarding the association of thrombosis on the splenoportal axis with various complications of portal hypertension. In particular, vein thrombosis is well known, with the evolution of "left portal hypertension", which is considered as the main cause of congestive splenomegaly and hemorrhages from fundal gastric varices. Several authors indicate the importance of portal thrombosis (TP) in the recurrence of variceal hemorrhages, worsening of ascites syndrome and liver failure (Merkel C., Bolognesi M., Bellon S. et al. Long-term follow-up study of adult patients with non -cirrhotic obstruction of the portal system: comparison with cirrhotic patients. In: J. Hepatol., vol. 299-303; Thompson R. J., McKie L. D. In: Ulster Med. J., 2006, vol. 75, no. 3, p. 175-177).

At the same time, the specialized literature data indicate a considerable rate of postoperative portal thrombosis in patients with liver cirrhosis and portal hypertension undergoing splenectomy with azygoportal disconnection, which includes limits of 13.3...29.2% of cases. This fact imposes the need to specify the factors predisposing to the evolution of post-splenectomy portal thrombosis, with the development of methods of prophylaxis and treatment of this complication.

The method of treatment of portal vein thrombosis (PVT) in patients with liver cirrhosis with the use of anticoagulants, namely low molecular weight heparin (LMWH) is known. Treatment with low molecular weight heparin is the initial treatment of choice. One study investigated 2 separate doses of LMWH (1.5 mg/kg daily and 1 mg/kg twice daily) showing a similar rate of recanalization with fewer bleeding complications in the twice daily dosing group [ 1].

The disadvantages of the known method are that in patients with a platelet count below 50,000/ul it does not lead to a reduction in hemorrhagic complications (K.I. Rodriguez-Castro, A. Vitale, M. Fadin, S. Shalaby, P. Zerbinati, M.T. Sartori, et al. A prediction model for cirrhotic portal vein thrombosis. Eur.

As the closest solution can be the method of treatment of portal vein thrombosis in patients with liver cirrhosis with the use of transjugular portosystemic intrahepatic shunt (TIPS) and performing mechanical thrombolysis to achieve portal vein recanalization. Catheter-based interventional therapy offers a safe and effective option for the treatment of symptomatic portomesenteric venous thrombosis refractory to medical therapy [2].

The disadvantages of the known method are that when using TIPS in the treatment of portal vein thrombosis, the characteristics of the thrombus must be taken into account (D. Tripathi, A. J. Stanley, P. C. Hayes, S. Travis, M. J. Armstrong, E. A. Tsochatzis, et al. Transjugular intrahepatic portosystemic stent -shunt in the management of portal hypertension. Gut., 2020, vol. 69, p. 1173-1192). TIPS is indicated in a patient with partial or even occlusive PVT (A. Luca, R. Miraglia, S. Caruso, M. Milazzo, C. Sapere, L. Maruzzelli, et al. Short- and long-term effects of the transjugular intrahepatic portosystemic shunt on portal vein thrombosis in patients with cirrhosis. Gut, 2011, vol. 60, p. 846-852), provided that the portal vein can still be identified. The presence of the portal cavernoma or the inability to identify the intrahepatic portal trunk or the branches of the intrahepatic portal vein significantly increases the technical difficulties of TIPS creation.

The problem that the invention solves consists in the development of an efficient and minimally invasive endovascular method of removing the thrombus formed in the portal vein system with the restoration of portal circulation to minimize portal hypertension and avoid severe post-thrombotic complications.

The essence of the invention is that an approach is performed in the subumbilical region with the introduction of an optical device and an approach under the left costal edge, in the projection of the spleen, with the introduction of a trocar with a diameter of 5 mm, through which, under visualization with the optical device, a needle with a blunt end, 15...20 cm long and 2...3 mm in diameter, which is inserted into the spleen parenchyma. Then a contrast substance is introduced through the needle and under X-ray control the needle is inserted into an intrasplenic venous branch. Through the mentioned needle, a guide catheter is inserted, which passes through the mentioned venous branch, then through the splenic vein and the portal vein, up to the area where the thrombus is located. After that, the guide is removed and the thrombotic masses are aspirated, and thrombolytic and anticoagulant preparations are introduced through the catheter. Then the catheter is pulled up to the level of the hilum of the spleen, and simultaneously with its extraction through the formed channel, two components of a fibrin glue are introduced, namely the first component includes fibrinogen solution 15...45 mg, and the second component includes a mixture of thrombin solution 25...100 IU, 10% albumin solution 10...20 ml, aprotinin solution 250...1000 KIU and Ca2+ chloride solution 15...30 µmol, with sealing of the channel from the parenchyma splenic. Then the catheter is removed and the wounds are sutured.

The result of the invention consists in the removal of the thrombus formed in the portal vein system with the restoration of portal circulation with the minimization of portal hypertension and the avoidance of severe post-thrombotic complications.

The advantages of the method consist of:

- miniinvasive endovascular method;

- complete removal of the thrombus with restoration of portal circulation;

- minimization of portal hypertension;

- avoiding severe post-thrombotic complications;

- avoiding hemorrhages from the spleen in patients with liver cirrhosis by applying fibrin glue.

The method is performed as follows.

After admission, the patient is prepared for surgical intervention. An approach is performed in the subumbilical region with the introduction of an optical device and an approach under the left costal rim, in the projection of the spleen, with the introduction of a trocar with a diameter of 5 mm, through which, under visualization with the optical device, a needle with the blunt end is inserted, with 15...20 cm long and 2...3 mm in diameter, which is inserted into the spleen parenchyma. Then a contrast substance is introduced through the needle and under X-ray control the needle is inserted into an intrasplenic venous branch. Through the mentioned needle, a guide catheter is inserted, which passes through the mentioned venous branch, then through the splenic vein and the portal vein, up to the area where the thrombus is located. After that, the guide is removed and the thrombotic masses are aspirated, and thrombolytic and anticoagulant preparations are introduced through the catheter. Then the catheter is pulled up to the level of the hilum of the spleen, and simultaneously with its extraction through the formed channel, two components of a fibrin glue are introduced, namely the first component includes fibrinogen solution 15...45 mg, and the second component includes a mixture of thrombin solution 25...100 IU, 10% albumin solution 10...20 ml, aprotinin solution 250...1000 KIU and Ca2+ chloride solution 15...30 µmol, with sealing of the channel from the parenchyma splenic. Then the catheter is removed and the wounds are sutured.

The claimed method was used in 3 patients with portal vein thrombosis on the background of liver cirrhosis and portal hypertension.

Example 1

Patient A., 34 years old, hospitalized in the surgery department with the diagnosis: Child C (10) decompensated liver cirrhosis of HCV viral etiology. Profuse variceal hemorrhage. Hemorrhagic shock gr. II. At fibroesophagogastroscopy, the presence of esophageal varices of gr. III-IV in the lower 1/3 of the esophagus. Anteromedial wall varices with a 0.2 cm tear with jet hemorrhage, Forrest Ia. Endoscopic hemostasis was performed by simultaneously injecting two components of the fibrin glue into the variceal lumen, the first component includes fibrinogen solution, and the second component includes the mixture of thrombin solution, 10% albumin solution, aprotinin solution and potassium chloride solution. Ca2+. During the ultrasonographic examination, splenomegaly and enlargement of the portal vein were detected. Computed tomography with contrast injection was performed, where portal vein thrombosis was diagnosed. Then the claimed endovascular method of treatment was used, where an approach was performed in the subumbilical region with the introduction of an optical device and an approach under the left costal rim, in the projection of the spleen, with the introduction of a trocar with a diameter of 5 mm, through which under visualization with the device optically, a needle with a blunt end, 20 cm long and 3 mm in diameter, was inserted into the parenchyma of the spleen. Then a contrast substance was introduced through the needle and under X-ray control the needle was inserted into an intrasplenic venous branch. A guide catheter was inserted through the mentioned needle, which passed through the mentioned venous branch, then through the splenic vein and the portal vein, until the area where the thrombus was located. After that, the guide was removed and the thrombotic masses were aspirated, and thrombolytic and anticoagulant preparations were introduced through the catheter. Then the catheter was pulled up to the level of the spleen hilum, and simultaneously with its extraction through the formed channel, two components of a fibrin glue were inserted, namely the first component includes fibrinogen solution 15...45 mg, and the second component includes a mixture of thrombin solution 25...100 IU, 10% albumin solution 10...20 ml, aprotinin solution 250...1000 KIU and Ca2+ chloride solution 15...30 µmol, with sealing of the channel from the parenchyma splenic. Then the catheter was removed and the wounds were sutured. Postoperatively, the treatment with anticoagulants and symptomatic therapy for the treatment of liver cirrhosis was prolonged. The patient was discharged after 10 days with extended outpatient treatment.

Example 2

Patient C., 58 years old, hospitalized in the surgery department with the diagnosis: Child C (10) decompensated liver cirrhosis of viral etiology HVB and HVD. Profuse variceal hemorrhage. Hemorrhagic shock gr. III. At fibroesophagogastroscopy, the presence of esophageal varices of gr. III-IV in the lower 1/3 of the esophagus and the cardiac region of the stomach. Anteromedial wall varices with a 0.2 cm tear with jet hemorrhage, Forrest Ia. Endoscopic hemostasis was performed by simultaneously injecting two components of the fibrin glue into the variceal lumen, the first component includes fibrinogen solution, and the second component includes the mixture of thrombin solution, 10% albumin solution, aprotinin solution and potassium chloride solution. Ca2+. During the ultrasonographic examination, splenomegaly and enlargement of the portal vein were detected. Computed tomography with contrast injection was performed, where portal vein thrombosis was diagnosed. Then the claimed endovascular method of treatment was used, where an approach was performed in the subumbilical region with the introduction of an optical device and an approach under the left costal rim, in the projection of the spleen, with the introduction of a trocar with a diameter of 5 mm, through which under visualization with the device optically, a needle with a blunt end, 20 cm long and 3 mm in diameter, was inserted into the parenchyma of the spleen. Then a contrast substance was introduced through the needle and under X-ray control the needle was inserted into an intrasplenic venous branch. A guide catheter was inserted through the mentioned needle, which passed through the mentioned venous branch, then through the splenic vein and the portal vein, until the area where the thrombus was located. After that, the guide was removed and the thrombotic masses were aspirated, and thrombolytic and anticoagulant preparations were introduced through the catheter. Then the catheter was pulled up to the level of the spleen hilum, and simultaneously with its extraction through the formed channel, two components of a fibrin glue were inserted, namely the first component includes fibrinogen solution 15...45 mg, and the second component includes a mixture of thrombin solution 25...100 IU, 10% albumin solution 10...20 ml, aprotinin solution 250...1000 KIU and Ca2+ chloride solution 15...30 µmol, with sealing of the channel from the parenchyma splenic. Then the catheter was removed and the wounds were sutured. Postoperatively, the treatment with anticoagulants and symptomatic therapy for the treatment of liver cirrhosis was extended. The patient was discharged after 10 days with extended outpatient treatment.

1. Marco Senzolo, Guadalupe Garcia-Tsao, Juan Carlos García-Pagán. Current knowledge and management of portal vein thrombosis in cirrhosis. J. of Hepatology, August 2021, vol. 75 (2), pp. 442-453

2. M.R. Chamarthy, M.E. Anderson, A.K. Pillai, S.P. Kalva. Thrombolysis and transjugular intrahepatic portosystemic shunt creation for acute and subacute portal vein thrombosis. Tech. Basque. interview Radiol, 2016, vol. 19, pp. 42-51

Claims (1)

Method of treatment of portal vein thrombosis in patients with liver cirrhosis, which consists of performing an approach in the subumbilical region with the introduction of an optical device and an approach under the left costal edge, in the projection of the spleen, with the introduction of a trocar with a diameter of 5 mm, through which a needle with a blunt end, 15...20 cm long and 2...3 mm in diameter, is inserted under visualization with the optical device, which is inserted into the parenchyma of the spleen, then a contrast substance is introduced through it and under X-ray control, the needle is inserted into an intrasplenic venous branch, then a guide catheter is inserted through the mentioned needle, which passes through the mentioned venous branch, then through the splenic vein and the portal vein, to the area where the thrombus is located, after which the guide is removed and the thrombotic masses are aspirated, and thrombolytic and anticoagulant preparations are introduced through the catheter, then the catheter is pulled up to the level of the spleen hilum, and simultaneously with its extraction, two components of a fibrin glue are introduced through the formed channel, namely the first component includes a solution of fibrinogen 15...45 mg, and the second component includes a mixture of thrombin solution 25...100 IU, 10% albumin solution 10...20 ml, aprotinin solution 250...1000 KIU and solution of Ca2+ chloride 15...30 µmol, with sealing of the channel from the splenic parenchyma, after which the catheter is removed and the wounds are sutured.