Method for performing radioembolization of pancreatic tumours

Abstract

The invention relates to medicine, and more particularly to oncology, and even more particularly to endovascular surgery. Under angiographic monitoring and local anaesthetic, the external iliac artery is catheterized by transfemoral access, the celiac artery is catheterized via an introducer, then the gastroduodenal artery is selectively catheterized and the distal portion thereof is embolized using embolization coils until a contrast agent reaches complete stasis in the proximal third of the artery, after which 99mTc-labelled albumin macroaggregates are introduced into the arterial stump and SPECT / CT is performed to visualize microsphere distribution; in the absence of microsphere migration into the systemic circulation, radioembolization is performed by introducing yttrium-containing glass microspheres into the stump of the gastroduodenal artery, and SPECT / CT is repeated. The proposed method has an economic and social impact since it makes it possible to improve patient quality of life by reducing pain syndrome.

Description

[0001]

[0002] A METHOD FOR PERFORMING RADIO EMBOLIZATION OF PANCREATIC TUMORS

[0003] The invention relates to medicine, namely to oncology, in particular to endovascular surgery.

[0004] Pancreatic cancer (PC) is the most aggressive and prognostically unfavorable tumor, most often localized in the head of the pancreas. Currently, surgery remains the primary radical treatment for pancreatic cancer. Three-quarters of PC patients require it, but only 10-20% of these patients are resectable. Chemotherapy is currently a mandatory component of pancreatic cancer treatment. Given that 80-85% of cases are unresectable at stage T4, symptomatic management and chemotherapy are the only treatment options. However, chemotherapy is ineffective, with a response rate of less than 20% of patients. The role of radiation therapy and chemoradiation therapy in induction therapy for pancreatic cancer has not been definitively determined, and its use remains at the physician's discretion.

[0005] A method for treating malignant pancreatic tumors (RU2156137C1) is known. This method involves performing fatty chemoembolization of the pancreas while administering Sandostatin, using 1 / 5 to 1 / 3 of a single dose of the chemotherapy drug administered into the arteries feeding the tumor, reducing their blood flow distal to the injection site. This method reduces the overall toxic effects of the chemotherapy drug and improves the patient's quality of life.

[0006] The disadvantages of this method are that it uses a chemotherapy drug, the effectiveness of which is currently ineffective, and the use of an oil-based embolization drug can lead to migration of the chemotherapy drug into the systemic bloodstream.

[0007] A method for selective chemoembolization of malignant tumors of the pancreas is known (RU2624323C2). With this method, a diagnostic catheter is installed in the proximal section of the gastroduodenal artery along a previously inserted standard diameter guidewire; a guidewire with a diameter of 0.014-0.018 inches is inserted into the right gastroepiploic artery to perform redistribution embolization, through which a balloon catheter is inserted distal to the site of origin of the arteries supplying the tumor, the diameter of which corresponds to the diameter of the right gastroepiploic artery in this segment and is inflated until complete cessation of blood flow through the right gastroepiploic artery; then, control angiography of the gastroduodenal artery is performed through the diagnostic catheter; upon cessation of blood flow through the right gastroepiploic artery, a chemoembolizate (lipiodol 3-7 ml and gemcitabine 400 mg / m2) is administered through the diagnostic catheter; if blood flow is preserved,The balloon catheter is replaced with a balloon catheter of a larger diameter, followed by its inflation and control angiography. After the procedure is completed, the balloon catheter is deflated and removed along with the guidewire and diagnostic catheter.

[0008] The disadvantages of this method are that after deflating the balloon catheter, the chemotherapy drug may migrate into the systemic bloodstream.

[0009] The prototype of the proposed technical solution is a method for the treatment of inoperable adenocarcinoma of the head of the pancreas (RU2706341C1). This method involves intra-arterial infusion of 50 mg / m 2Oxaliplatin is administered over 20 minutes through a catheter inserted into the gastroduodenal artery. A bolus of 50 mg / m2 of abraxane in no more than 5 ml of lipiodol is then administered. The catheter is then reinserted into the celiac trunk, and 1000 mg / m2 of gemcitabine is administered intra-arterially over one hour. Following completion of chemotherapy, conformal radiotherapy sessions are administered by multifractionating daily fractions of 2 Gy twice daily with an interval of at least 6 hours between them to a total physical focal dose of 50 Gy, which is equivalent to 60 Gy of conventional fractionation. Systemic chemotherapy is then administered by orally administering capecitabine at 2500 mg / m2 daily. 2per day in 2 doses, morning and evening, for no more than 14 days. Then, no earlier than 2 weeks later, oxaliplatin chemoinfusion and chemoembolization with abraxane in lipiodol are repeated several times in the same regimens, followed by gemcitabine infusion into the celiac trunk and oral administration of capecitabine for no more than 14 days, no more than once a month for no more than 4 months or until grade II-III adverse events occur, or tumor progression occurs according to RECIST criteria.PC17RU2025 / 000142

[0010] The disadvantages of this method are that it uses total doses of 60 Gy and also uses radiocontrast oil for chemoembolization, which can migrate into the systemic bloodstream.

[0011] Our previous experience in treating patients with pancreatic cancer allows us to say that the use of conservative treatment methods in the vast majority of cases is ineffective and does not significantly affect the quality of life of patients.

[0012] The technical result of the claimed method is a reduction in pain and an improvement in the patient’s quality of life.

[0013] The said technical result in the implementation of the invention is achieved due to the fact that, just as in the known method, radioembolization is performed.

[0014] The peculiarity of the claimed method is that under angiographic control, under local anesthesia, the external iliac artery is catheterized through a transfemoral approach, the celiac trunk is catheterized through an introducer, then the gastroduodenal artery is selectively catheterized and embolization of its distal part is performed with metal embolization coils until complete stasis of the contrast agent in the proximal third of the artery, after which albumin macroaggregates labeled with 99mTc are introduced into the arterial stump and SPECT / CT is performed to visualize the distribution of microspheres and, in the absence of migration of microspheres into the systemic bloodstream, radioembolization is performed by introducing yttrium-containing glass microspheres into the stump of the gastroduodenal artery and SPECT / CT is repeated.

[0015] The invention is explained by a detailed description, a clinical example and illustrations, which depict:

[0016] Fig. 1 - Angiogram of the celiac trunk of patient K., before treatment.

[0017] Fig. 2 - Angiogram of the celiac trunk of patient K., after embolization of the distal part of the gastroduodenal artery.

[0018] Fig. 3 - SPECT / CT after the introduction of 99mTc-labeled albumin macroaggregates. Fig. 4 - SPECT / CT after the introduction of yttrium-containing glass microspheres. The method is performed as follows.

[0019] Following a comprehensive examination, including chest and abdominal CT, gastroscopy, and general clinical and blood biochemistry assessment, celiac trunk angiography is performed. Under local anesthesia with 0.5% novocaine (40 ml), the external iliac artery is catheterized via a right-sided transfemoral approach. The celiac trunk is catheterized through an introducer with a diagnostic catheter. The gastroduodenal artery is then selectively catheterized, and its distal portion is embolized with metal embolization coils until complete stasis of the contrast agent in the proximal third of the artery. Following this, in the first stage, albumin macroaggregates labeled with 99mTc are injected into the arterial stump, and single-photon emission computed tomography (SPECT / CT) is performed to visualize the distribution of the microspheres.In the absence of migration of microspheres into the systemic bloodstream and shunting into the lungs, a second stage is carried out, in which radioembolization is performed by introducing yttrium-containing glass microspheres into the stump of the gastroduodenal artery and SPECT / CT is performed.

[0020] Clinical example of the method implementation.

[0021] Patient K., 68 years old. History: Due to the onset of girdle-like pain in June 2024, an abdominal ultrasound was performed, which revealed a mass in the head of the pancreas. Due to clinical signs of mechanical jaundice, percutaneous external bile duct drainage was performed on August 19, 2024.

[0022] Cytologically as of 08 / 22 / 2024: highly differentiated adenocarcinoma.

[0023] Four courses of chemotherapy with GemOX were administered until October 30, 2024. Chemotherapy was discontinued due to severe hematological toxicity.

[0024] In the Department of X-ray Surgical Diagnostic and Treatment Methods, the external iliac artery was catheterized using a right-sided transfemoral approach under local anesthesia with 0.5% novocaine (40 ml). The celiac trunk was catheterized through the introducer with a diagnostic catheter (Fig. 1). Then, the gastroduodenal artery was selectively catheterized, and its distal portion was embolized with metal embolization coils until complete stasis of the contrast agent in the proximal third of the artery (Fig. 2). Following this, albumin macroaggregates labeled with 99mTc were injected into the arterial stump, and SPECT / CT was performed to visualize the distribution of microspheres (Fig. 3). Migration of microspheres into the systemic circulation and shunting of the drug into the lungs were not visualized. Next, radioembolization was performed by introducing yttrium-containing glass microspheres into the stump of the gastroduodenal artery and SPECT / CT was performed (Fig. 4).

[0025] According to SPECT / CT data, the distribution of yttrium-containing glass microspheres within the tumor was observed, similar to the distribution of albumin macroaggregates labeled with 99mTc. During the first day after radioembolization, minor pain in the upper abdomen was noted, relieved by nonsteroidal anti-inflammatory drugs.

[0026] Within 2 weeks, a decrease in pain was noted, no complications were identified.

[0027] The proposed method has an economic and social effect, as it improves the quality of life of patients due to a reduction in pain.

Claims

PC17RU2025 / 000142 CLAUSES OF THE INVENTION A method for radioembolization of pancreatic tumors, including radioembolization, characterized in that under angiographic control, under local anesthesia, the external iliac artery is catheterized through a transfemoral approach, the celiac trunk is catheterized through an introducer, then the gastroduodenal artery is selectively catheterized and embolization of its distal part is performed with metal embolization coils until complete stasis of the contrast agent in the proximal third of the artery, after which albumin macroaggregates labeled with 99mTc are introduced into the arterial stump and SPECT / CT is performed to visualize the distribution of microspheres and, in the absence of migration of microspheres into the systemic bloodstream, radioembolization is performed by introducing yttrium-containing glass microspheres into the stump of the gastroduodenal artery and SPECT / CT is repeated.

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