Method for treatment of patients with mechanical jaundice syndrome

Abstract

FIELD: medicine.SUBSTANCEinvention relates to medicine, namely to interventional radiology and biliary surgery, and can be used in the treatment of patients with obstructive jaundice syndrome. After stopping external bile drainage, a guidewire is inserted into the bile ducts through the previously installed cholangiostomy drainage to the stenting area. The drainage is removed. The outer part of the collagen obturator delivery system, an introducer with a bougie, is inserted along the guidewire. Direct cholangiography is performed, after visualization of the bile ducts, the delivery system is pulled into the liver parenchyma, retreating in the distal direction by 1 cm from the bile ducts. The guidewire and bougie are removed, and an internal hollow tube with a radiopaque marker at the end, containing a collagen obturator, is inserted into the introducer. The radiopaque marker is placed 1 cm from the bile ducts. Using a stylet, the collagen obturator is pushed out with simultaneous tightening of the delivery system, sealing the unformed cholangiostomy canal.EFFECT: method ensures high accuracy of implantation of a collagen obturator at a given level, a reduction in the risk of bleeding and / or bile leakage into the abdominal cavity during early removal of a cholangiostomy drainage or in the case of slow formation of a competent sealed channel from connective tissue separating the bile ducts and liver parenchyma from the abdominal cavity, due to preliminary performance of direct cholangiography, control of the contrast marker at the distal end of the delivery system and precise sealing of the unformed cholangiostomy channel with a collagen obturator.1 cl, 3 dwg, 1 tbl, 1 ex

Description

[0001] The invention relates to medicine, namely to interventional radiology and minimally invasive surgery.

[0002] The number of patients with mechanical jaundice of various etiologies is growing every year. Regardless of the nature of the mechanical blockage in the bile ducts, patients require emergency surgical intervention.

[0003] Often, mechanical jaundice syndrome is accompanied by the development of cholangitis and liver failure, which increases the risk of postoperative complications [1].

[0004] A safer treatment method for patients is minimally invasive interventional surgery, specifically percutaneous transhepatic interventions. Unlike retrograde endoscopic bile duct decompression methods (EPSD, stenting with a plastic stent), antegrade interventions have the advantage of eliminating the need to dissect the major duodenal papilla and can be used at various levels of the block [2]. However, it is worth noting that antegrade minimally invasive surgical interventions also carry a risk of postoperative complications.

[0005] During the first stage of treatment—creating a percutaneous transhepatic cholangiostomy—drainage dislocation and leakage of blood and / or bile into the abdominal cavity may occur. Infected bile in the abdominal cavity leads to the development of biliary peritonitis, with subsequent characteristic complications, including death. The second stage of treatment for patients with obstructive jaundice involves antegrade stenting of the stenosis.

[0006] Due to the fact that the self-expanding stent does not immediately reduce intraductal pressure, bile will flow out along the pressure gradient through the unformed cholangiostomy channel into the abdominal cavity.

[0007] It should also be taken into account that the presence of a cholangiostomy tube significantly reduces the patient’s quality of life [3].

[0008] A number of studies have shown that the average time for a mature cholangiostomy channel to form is 20 days [4]. However, in some cases, a longer period of time is required to form a mature tract connecting the liver to the anterior abdominal wall. This is due to a number of factors and, in most cases, occurs due to pathological changes in the liver parenchyma, such as cirrhosis, post-chemotherapy conditions, total metastatic liver damage, or the systemic effects of liver diseases complicated by the development of ascites and hypoalbuminemia. In such pathological conditions, the liver's reparative capacity, which is essential for the formation of cicatricial changes and the construction of a sealed puncture channel, is reduced.

[0009] Of the existing methods for resolving postoperative complications, there are two options: repeated ultrasound-guided bile duct drainage or laparoscopic interventions. Given the severity of the patient's condition, even laparoscopic procedures carry a high risk of postoperative complications, including death [1].

[0010] The objective of the invention is to improve the treatment results for patients with mechanical jaundice syndrome, reduce the risk of developing postoperative complications and prevent the need for repeated minimally invasive or laparoscopic intervention.

[0011] The task is solved by performing precision obturation of the cholangiostomy canal when stopping external bile drainage using a collagen obturator delivery system, which makes it possible to simultaneously stop bleeding and bile leakage, seal the bile ducts and accelerate the healing process.

[0012] The essence of the proposed method is as follows:

[0013] 1. As the first stage of treatment for patients with obstructive jaundice, a percutaneous transhepatic cholangiostomy is performed. Depending on the clinical presentation, patients undergo immediate or delayed stenting of the stenosis area with a nitinol self-expanding biliary stent.

[0014] 2. A guidewire is inserted into the bile duct through the previously installed cholangiostomy drainage.

[0015] 3. The external part of the delivery system is inserted along the guidewire: a plastic introducer with a bougie.

[0016] 4. Direct cholangiography is performed to visualize the bile ducts.

[0017] 5. Together with the guidewire, the delivery system is pulled into the liver parenchyma to a distance of at least 1 cm from the bile ducts. The guidewire is removed.

[0018] 6. An internal hollow tube containing a collagen polymer and a radiopaque marker at the end is inserted into the introducer. The tube contains four collagen plugs; the number of implants will be determined depending on the width and length of the cholangiostomy canal. Ensure that the radiopaque marker is positioned 1 cm from the bile ducts.

[0019] 7. Once the distal end of the delivery system is correctly positioned, the collagen polymer is pushed out by twisting the stylet and simultaneously pulling up the delivery system.

[0020] The technical result of the proposed method is to reduce the risk of bleeding and / or bile leakage into the abdominal cavity during early removal of cholangiostomy drainage or in the case of slow formation of a competent sealed channel from connective tissue that separates the bile ducts, liver parenchyma from the abdominal cavity.

[0021] An identical set of essential features was not found during a review of the scientific, medical, and patent literature. Therefore, this technical solution meets the invention criteria: novelty, inventive step, and industrial applicability.

[0022] The effectiveness of the proposed method is illustrated by the following clinical examples.

[0023] Clinical Example 1

[0024] Patient B., 59 years old. Diagnosis: Cadaveric liver transplantation on December 2, 2023, for liver cirrhosis resulting from AIH + PSC. Stricture of the common bile duct of the liver transplant.

[0025] The patient was admitted urgently with obstructive jaundice syndrome caused by a stricture in the common bile duct anastomosis area. An endoscopic plastic stent had previously been placed in the main pancreatic duct. To restore bile flow and reduce biliary hypertension, the patient first underwent percutaneous transhepatic cholangiostomy. Five days later, significant narrowing of the intrahepatic bile ducts to normal values ​​was noted. The second stage of treatment for obstructive jaundice was antegrade placement of an uncovered self-expanding biliary stent under radiographic guidance. However, due to the patient's compromised liver (transplanted organ), a decision was made to place a safety cholangiostomy drain above the stenting area.After 2 days, the patient underwent cholangiography, which visualized the complete opening of the stent and the active outflow of the contrast agent into the lumen of the duodenum.

[0026] As a final stage of treatment, the formed cholangiostomy canal was sealed with a collagen polymer.

[0027] The cholangiostomy obturation was performed in several stages:

[0028] 1. After the administration of the contrast agent, the intra- and extrahepatic bile ducts were completely stained, which allowed us to determine the boundaries of the collagen obturator placement.

[0029] 2. A rigid guidewire was inserted through the previously installed cholangiostomy to the stenting area.

[0030] 3. The delivery system (external introducer, internal bougie) was advanced along the guidewire to the verified location (1 cm lateral to the bile ducts). After the introducer was positioned at the designated point, the guidewire and internal bougie were removed from the bile ducts (Fig. 1).

[0031] 4. A hollow tube with a radiopaque marker and collagen polymer was inserted into the introducer. By advancing the internal stylet, the polymer was injected along the tract (Fig. 2). Given the length of the cholangiostomy canal, all four collagen plugs were implanted.

[0032] After placement of the obturating polymer, immediate cessation of contrast agent outflow beyond the bile ducts of the liver was noted (Fig. 3). Following the minimally invasive surgical procedure, the patient was observed in the specialized department for 5 days.

[0033] Laboratory tests revealed positive dynamics (Table 1, see graphic section). Also, following a series of minimally invasive surgical interventions, ultrasound results showed that the bile ducts were not dilated, with lobar dilation up to 2-3 mm and common bile duct up to 8 mm, with a stent visible in the lumen. No free fluid was detected in the abdominal cavity.

[0034] Brief description of drawings

[0035] Fig. 1. Radiography. Inserting a hollow tube with a radiopaque marker into the designated point.

[0036] Fig. 2. Pushing out collagen polymer from the inner hollow tube with the internal stylet.

[0037] Fig. 3. Radiography.

[0038] A - Cholangiography after implantation of a collagen polymer (complete cessation of the outflow of contrast agent through the cholangiostomy channel outside the liver).

[0039] B - Cholangiography with safety drainage.

[0040] B - Radiography before administration of contrast agent.

[0041] Literature

[0042] 1. Ivshin V.G. et al. Comparative characteristics of various methods of percutaneous bile-draining interventions in patients with mechanical jaundice / / Annals of surgical hepatology. - 2003. - V. 8. - No. 2. - P. 14-18.

[0043] 2. Kulezneva Yu.V., Izrailov R.E., Urakova N.A. Percutaneous transhepatic stenting of the bile ducts (indications, technique, results) / / Diagnostic and interventional radiology. - 2008. - V. 2. - No. 4.- P. 87-93.

[0044] 3. Avanesyan R.G., Korolev M.P., Fedotov L.E., Turyanchik M.M., Sabri S.N. Complications of percutaneous minimally invasive endobiliary operations. Annals of surgical hepatology. 2019; 24(2):88-99. https: / / doi.org / 10.16931 / 1995-5464.2019288-99

[0045] 4. Wise J. N. et al. Percutaneous cholecystostomy catheter removal and incidence of clinically significant bile leaks: a clinical approach to catheter management / / American Journal of Roentgenology. - 2005. - V. 184. - №. 5. - P. 1647-1651.

[0046] 5. Behrens, Adam M.; Sikorski, Michael J.; Kofinas, Peter (2014). Hemostatic strategies for traumatic and surgical bleeding. Journal of Biomedical Materials Research Part A, 102(11), 4182-4194. doi:10.1002 / jbm.a.35052

Claims

A method for treating patients with mechanical jaundice syndrome, including the formation of a percutaneous transhepatic cholangiostomy, stenting the narrowing zone with a biliary self-expanding stent, characterized in that after cessation of external bile drainage, a guidewire is inserted into the bile ducts through a previously installed cholangiostomy drainage to the stenting zone, the drainage is removed, the external part of the collagen obturator delivery system - an introducer with a bougie - is inserted through the guidewire, direct cholangiography is performed, after visualization of the bile ducts, the delivery system is pulled into the liver parenchyma, retreating in the distal direction by 1 cm from the bile ducts;the guidewire and bougie are removed, an internal hollow tube with a radiopaque marker at the end containing a collagen obturator is inserted into the introducer, the radiopaque marker is positioned 1 cm from the bile ducts, using a stylet the collagen obturator is pushed out with simultaneous tightening of the delivery system, sealing the unformed cholangiostomy canal.

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