RU2818642C2 - Method of performing video cholangioscopy - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to endoscopic methods of diagnostics and treatment in oncology. Cholangioscope is inserted into the bile ducts retrograde or antegrade. Sterile 10 % dextran solution with molecular weight of 30,000 to 40,000 Da is bolus introduced into the bile ducts through the irrigation canal of the flexible cholangioscope. Total volume of sterile 10 % dextran solution used in one study is 7 to 20 ml.

EFFECT: method provides good visualization of bile ducts, which reduces time of intervention, enables to obtain an adequate amount of material for morphological verification, reducing the need for repeated hospitalizations, which reduces the time before the start of a specific treatment, provides reduction of number of post-manipulation complications, reducing length of stay in hospital, and also reduces the surgical and anaesthetic risk, duration of anaesthetic care, radiation exposure on the patient and medical personnel.

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Description

The invention relates to medicine, in particular to endoscopic methods of diagnosis and treatment in oncology, and can be used in the diagnosis and treatment of bile duct pathology.

The problem of differential diagnosis of bile duct neoplasms has remained relevant over the past decades.

Detailing the topography of a bile duct tumor, as well as obtaining material for morphological verification under direct endoscopic control, is a promising method for clarifying diagnosis. One of the main components of successful research is achieving optimal visualization by creating an optical environment with a minimum amount of artifacts, the most widely used of which are carbon dioxide and saline sodium chloride solution.

The well-known method for endoscopic diagnosis and treatment of patients with pathology of the bile ducts [Doi S. et al., 2011] was taken as a prototype. The method includes performing both antegrade (using an available model of a cholangioscope, carried out into the bile ducts percutaneously using a pre-formed access) and retrograde (using an available model of a cholangioscope, carried out into the bile ducts retrogradely through the working channel of a therapeutic duodenoscope after performing papillosphincterotomy) cholangioscopy, during which, through the irrigation channel of the cholangioscope, an isotonic solution of sodium chloride/carbon dioxide is irrigated/insufflated (Fig. 1) to create an optical environment with optimal visualization parameters (color, texture, etc.), allowing the assessment of endoscopic semiotics and distribution along the ducts , as well as perform adequate sampling of material for morphological verification. The average time to achieve optimal visualization using carbon dioxide/saline is 22.5 minutes.

The disadvantage of this method is that the use of these media (especially after contrasting the bile ducts with water-soluble iodine-containing contrast) is associated with the problem of image detail due to the accompanying formation of artifacts (bubbles, refraction at the interface of the media, bile sludge, mucin), which is accompanied by an increase in the volume of instillation/insufflation , which in turn can lead to undesirable consequences and complications (cholangitis, aspiration, air embolism, barotrauma, bile-venous reflux, reflex hypotension), increased intervention time, increased radiation exposure to the patient and medical personnel [Ueki T. et al. , 2010]. In addition, despite data from studies conducted on animal models, the safe rate of CO2 insufflation into the bile ducts has not yet been determined [Mukewar S. et al., 2016]. On the other hand, the presence of optical artifacts also reduces the frequency of obtaining an adequate first sample when performing a biopsy under cholangioscopic control, which significantly reduces the sensitivity, accuracy and specificity in diagnosis and increases the time before specific treatment is prescribed.

The use of low molecular weight colloidal solutions can eliminate the disadvantages described above.

The technical result of the invention is the development of a method for performing cholangioscopy for the diagnosis and treatment of patients with bile duct pathology, allowing for better visualization of the bile ducts, reducing intraductal pressure and examination time, reducing the risk of adverse reactions and complications identified when using isotonic sodium chloride/CO2 solution, as well as radiation exposure to the patient and medical personnel.

The specified technical result in the implementation of the invention is achieved due to the fact that, as in the known method, a cholangioscope is inserted into the bile ducts retrogradely or antegradely.

A feature of the proposed method is that through the irrigation channel of a flexible cholangioscope, a sterile 10% dextran solution with a molecular weight of 30,000 to 40,000 Da is injected into the bile ducts as a bolus, and the total volume of the sterile 10% dextran solution used in one study ranges from 7 ml to 20 ml . Moreover, if artifacts occur during video cholangioscopy, a 10% dextran solution is added in portions.

The invention is illustrated by a detailed description, clinical examples and illustrations, which show:

fig. 1 – endophoto of the bile ducts during retrograde cholangioscopy using sodium chloride solution as an optical medium.

fig. 2 – endophoto of a biopsy of the formation of the bile ducts during retrograde cholangioscopy using a 10% dextran solution with a molecular weight of 30,000 to 40,000 Da as an optical medium.

fig. 3 – photo illustration of the result of endoscopic stenting: a) endophoto of the bile ducts during antegrade cholangioscopy using a 10% dextran solution with a molecular weight of 30,000 to 40,000 Da as an optical medium before performing endoscopic stenting of the area of tumor stricture; b) endophoto of the bile ducts during antegrade cholangioscopy using a 10% dextran solution with a molecular weight of 30,000 to 40,000 Da as an optical medium immediately after endoscopic stenting of the area of tumor stricture.

The method is carried out as follows.

The cholangioscope is passed along a guide wire through a previously made access to the bile ducts retrogradely (with the help of a duodenoscope, a papillotome is used to cannulate the bile duct along a guide wire, followed by endoscopic papillosphincterotomy, after which the papillotome is removed) or antegrade (after percutaneous transhepatic cholangiostomy and dilatation are performed. B If the patient has a formed percutaneous transhepatic cholangiostomy, a conductor string is inserted into the bile ducts through the drainage under X-ray control. The drainage is removed). A sterile 10% dextran solution with a molecular weight of 30,000 to 40,000 Da is injected as a bolus through the irrigation channel of the cholangioscope until optimal visualization is achieved. During the study, to eliminate artifacts that arise during the work, an additional 10% dextran solution with a molecular weight of 30,000 to 40,000 Da is introduced in portions, which in a total volume ranges from 7 ml to 20 ml. After completion of intraductal manipulations, the cholangioscope is removed.

The proposed molecular weight allows the solution to be retained in the lumen of the bile ducts and does not require additional rinsing after completion of the procedure.

The claimed method of intraductal cholangioscopy was performed in 52 patients.

Clinical example No. 1

Patient Kh., 53 years old, was hospitalized at the Moscow Research Institute named after P.A. Herzen with a clinical diagnosis: Cancer of the extrahepatic bile duct cT2aN1M1 (mts hep) stage IVb.

From the anamnesis: he considers himself sick since 09.2021, when pain in the epigastrium began to bother him. I went to the clinic at my place of residence, where, according to esophagogastroduodenoscopy, a picture of chronic gastritis, duodenitis, and the phenomenon of duodenogastric reflux was revealed. Conservative therapy was prescribed - without effect.

Upon further examination, according to a computed tomography scan of the abdominal cavity dated 09.2021, a neoplasm of the extrahepatic bile ducts with secondary liver damage was noted. Verification was not performed.

On 10.2021, the patient was sent to the Moscow Research Institute named after P.A. Herzen in order to clarify treatment tactics. According to an ultrasound examination of the abdominal organs dated 10.2021, there is an echographic picture of the disease of the extrahepatic bile ducts with signs of spread to the tissue of the liver gates, involvement in the process of the confluence of the lobar ducts, and secondary changes in the liver. ECHO picture of biliary hypertension.

10/12/2021 in the conditions of the endoscopy department of the Moscow Research Institute named after P.A. Herzen, the patient underwent retrograde cholangioscopy, biopsy of the bile duct formation, and retrograde endoscopic stenting of the bile ducts.

Intraoperatively: the endoscope is passed into the duodenum. The major duodenal papilla is up to 4 mm, the mucous membrane is icteric, the mouth is slit-like, without bile flow at the time of examination. Longitudinal fold up to 10 mm. Selective cannulation of the bile duct was performed using a guide wire, 5 ml of water-soluble contrast iopromide 300 was injected. At a level of 70 mm from the wall of the duodenum, the lumen was narrowed to slit-like for 15 mm, the sectoral ducts of the right lobe were expanded to 10 mm. Endoscopic papillosphincterotomy was performed. The papillotome is removed.

Retrograde cholangioscopy was performed using a guide wire. A bolus of 7 ml of sterile 10% dextran solution with a molecular weight of 30,000 to 40,000 Da was injected, which is sufficient to achieve good visualization. At a level of 70 mm from the wall of the duodenum, the distal edge of tumor infiltration is determined, occupying ¾ of the circumference of the bile duct. A biopsy of the formation was performed under visual control (Fig. 2). The material was sent for pathomorphological examination. 2 conductor strings are installed in the lumen of the sectoral ducts of the right lobe. During the intervention, a 10% dextran solution with a molecular weight of 30,000 to 40,000 Da was introduced in portions to eliminate artifacts. The total volume of the solution was 20 ml. The duration of cholangioscopy with biopsy and insertion of guidewires is 10 minutes. Two self-expanding stents 6–100 mm were installed along the strings. There is an active flow of “discolored” bile through the lumens of the stents.

There were no complications noted in the postoperative period. The patient was discharged to continue treatment on an outpatient basis on day 2.

According to a cytological study dated October 13, 2021, a cytogram of moderately differentiated adenogenic cancer. The situation was discussed at the oncology council dated 10.2021, specific treatment was prescribed in the scope of a course of chemotherapy according to the GemCis regimen.

Clinical example No. 2

Patient A., 68 years old, was hospitalized at the Moscow Research Institute named after P.A. Herzen with a clinical diagnosis: Cancer of the extrahepatic bile duct cT4N1M0 stage IIIC. Type IV according to Bismuth-Corlette.

From the anamnesis: she considers herself sick since 01.2023, when she first noticed yellowness of the sclera and skin, for which she went to the clinic at her place of residence. A comprehensive examination in the area of the hepatic hilum revealed a space-occupying formation involving the parenchyma and structures of the hepatic hilum. On 02.2023, external drainage of the bile ducts was performed. On 04.2023, an attempt was made to biopsy the formation. According to the morphological study - without tumor growth. On 06.2023, due to a repeated episode of obstructive jaundice, re-drainage of the bile ducts was performed.

On 07.2023, the patient was sent to the P. A. Herzen Moscow Oncology Research Institute to clarify treatment tactics. According to a CT scan of the abdominal organs dated 07.2023 - a CT picture of a tumor infiltrate at the porta hepatis involving the bile ducts, vascular structures, liver parenchyma, probably growing to the wall of the stomach and duodenum (may correspond to Klatskin tumor type IV according to Bismuth -Corlette). Biliary hypertension, a condition after drainage of the bile ducts. Enlarged hilum of the liver.

On 08/03/2023, in the endoscopy department of the P. A. Herzen Moscow Oncology Research Institute, the patient underwent a biopsy of the formation of the hepatic porta region under the control of endosonography, and retrograde endoscopic stenting of the bile ducts. According to a morphological study dated August 3, 2023, no tumor growth.

On 10/11/2023, in the endoscopy department of the P. A. Herzen Moscow Research Institute of Orthopedics, the patient underwent antegrade cholangioscopy, biopsy of the bile duct formation, and antegrade endoscopic stenting of the bile ducts.

Intraoperatively: a 10 Fr cholangiostomy drainage is visualized in the right hypochondrium with turbid contents entering paradrainage. 6 ml of water-soluble contrast iopromide 300 was injected through external drainage. The contrast filled the anterior and superior sectoral ducts with a diameter of up to 4-5 mm. After preoperative skin treatment, the external drainage is removed through a guidewire under X-ray control.

A cholangioscope was inserted antegrade into the bile ducts along a guide wire. A bolus of 5 ml of a sterile 10% dextran solution with a molecular weight of 30,000 Da to 40,000 Da was injected. Optimal visualization of intraductal structures has been achieved. At the level of the proximal part of the right lobar duct, a circular red infiltration with severe bleeding and an amorphous pattern of the mucous membrane and capillaries is visualized (Fig. 3a). The length of the stenotic area is 20 mm. A biopsy of the formation was performed under visual control. The material was sent for pathomorphological examination. A conductor string is installed into the lumen of the right lobar duct. During the intervention, to eliminate artifacts, a 10% dextran solution with a molecular weight of 30,000 D to 40,000 Da was introduced in portions. The total volume of the solution was 7 ml. The duration of antegrade cholangioscopy with biopsy and guide wire insertion is 8 minutes. An 8-60 mm self-expanding stent was installed along the string antegradely. With antegrade endoscopic control, the proximal edge of the stent is above the narrowing area (Fig. 3b). According to X-ray control, there is an active flow of contrast into the lumen of the duodenum.

There were no complications noted in the postoperative period. The patient was discharged to continue treatment on an outpatient basis on day 2.

According to a cytological study dated October 19, 2023, there are complexes of adenogenic cancer against the background of inflammation. The situation was discussed at an oncology council on 10.2023, and specific treatment was prescribed including a course of chemotherapy according to the GemCis regimen.

The proposed method of performing intraductal cholangioscopy provided a reduction in intervention time, a decrease in the number of post-manipulation complications, and also made it possible to achieve better visualization of the bile ducts in comparison with the standard technique using an isotonic solution of sodium chloride or carbon dioxide in patients with pathology of the bile ducts.

The invention has a social and economic effect, because:

- allows you to obtain an adequate amount of material for morphological verification, reducing the need for repeated hospitalizations to attempt to verify bile duct neoplasms, which reduces the time before the start of specific treatment;

- reduces the number of post-manipulation complications, reducing the length of hospital stay;

- reduces surgical and anesthetic risk, duration of anesthesia, radiation exposure to the patient and medical staff.

Claims (2)

1. A method of performing video cholangioscopy, including introducing a cholangioscope into the bile ducts retrogradely or antegrade, characterized in that a sterile 10% dextran solution with a molecular weight of 30,000 to 40,000 Da is injected into the bile ducts via a bolus through the irrigation channel of the flexible cholangioscope, and the total volume of sterile 10 used is 10 The % of dextran solution per study ranges from 7 to 20 ml. 2. The method according to claim 1, characterized in that when artifacts occur during video cholangioscopy, a 10% dextran solution is added in portions.