RU2617108C1 - Method for primary sclerogenic preventive hemostasis at esophagus and stomach varicose veins bleeding height - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: method comprises intravasal administration of Aethoxysklerol microfoam to the esophageal vein lumen. Microfoam is prepared by 3% Aethoxysklerol mixing with air at a ratio of 1:6 or 1% Aethoxysklerol mixing with air at a ratio of 2:6. The resulting 7-8 ml of Aethoxysklerol microfoam is introduced into the esophageal or stomach bleeding vein lumen via an injector 1.5 cm proximal to the bleeding source. If necessary, injections are repeated in other veins, further 2 ml of 1% hydrogen peroxide solution is administered paravasally submucosally at the cardia level from each side of the vein. Hemostasis is monitored after 8-12 hours, if necessary, the procedure is repeated after 6 days, 1, 3, 6 months.

EFFECT: method allows to effectively stop bleeding from varicose veins with simultaneous sclerotherapy, providing prevention of bleeding, is easy to use and safe.

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Description

The invention relates to medicine, in particular endoscopy, and can be used for endoscopic hemostasis with active bleeding from varicose veins (HRV) of the esophagus and stomach, as well as for the prevention of relapse of varicose bleeding.

The most serious complication of portal hypertension and the main cause of death in patients with cirrhosis of the liver are varicose bleeding from the veins of the esophagus and stomach. According to foreign data, despite the achievements of modern medicine, mortality during the first six weeks after an episode of varicose bleeding remains at the level of 10-20% (Roberto de Franchis. Expanding consensus in portal hypertension. Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. Journal of Hepatology. 2015; 63: 743-752), while domestic authors report even higher rates exceeding 50%. A relapse of bleeding in the hospital during the first five days occurs in 25-37% of patients and leads to the death of 2/3 of them (Garelik P.V., Mogilevets E.V., Batvinkov N.I. Prevention of early relapse of bleeding when using a probe Sengstaken-Blackmore in patients with portal hypertension // Journal of Grodno State Medical University. 2012. No. 3. P. 11-15).

Despite the recommendations of Baveno VI, in modern domestic medicine, the installation method for active varicose bleeding is still almost everywhere the installation of a Blackmore probe, although the disadvantages of this method are known: the development of ulcerations and necrosis of the mucous membrane of the esophagus and stomach, higher mortality compared to endoscopic hemostasis, as well as a high risk of early relapse of bleeding (50-60%).

The “gold standard” for the treatment of BPV of the esophagus is endoscopic ligation (EL) with latex rings, which is performed using a special ligation device Z.A. Saeed with a set of 6-10 latex rings mounted on the distal end of the endoscope. Ligation begins with the area of the esophagocardial transition, just above the dentate line. The selected varicose node is aspirated into the cylinder by an aspirator, after which the ring is discarded. With ongoing or completed bleeding, the first ligature must be applied to the source of bleeding, and then the rest of the BPH are ligated. After EL from 3 to 7 days, the ligated nodes are necrotic, decrease in size, and are densely covered with fibrin. By 7-8 days, rejection of necrotic tissues with ligatures and the formation of extensive superficial ulcerations begin. Ulcers heal by day 14-21, leaving stellate scars, without stenosis of the lumen of the esophagus. By the end of the 2nd month after EL, the submucosal layer is replaced by scar tissue, and the muscle layer remains intact (Clinical recommendations for the treatment of bleeding from varicose veins of the esophagus and stomach // National Clinical Recommendations of the Russian Society of Surgeons, Voronezh, 2014).

However, with continued bleeding, the use of this method is extremely difficult due to poor visibility with massive blood flow and poor orientation to capture the vein, which decreases with bleeding, which leads to technical ligation defects with the development of complications such as bleeding recurrence or stenosis. ELV is technically impossible due to the anatomical features of the stomach veins, and also leads to the formation of gastric ulcers in the area of latex rings for 1-2 days after the procedure and subsequent bleeding (Scherzinger A.G., Zhigalova S.B. Features of diagnosis and treatment varicose veins of the esophagus and stomach // Actual issues of endoscopy: materials of the report of the All-Russian Conf., St. Petersburg, March 25-26, 2010).

Endoscopic sclerotherapy (ES) is also an effective method in achieving sustainable hemostasis. The technique consists in obliterating a vein after introducing into its lumen a small volume of a sclerosant solution (1-2 ml) through an endoscope using a long needle. For these purposes, ethanolamine oleate, sodium tetradecyl sulfate (fibrowane), polydocanol (ethoxysclerol), adhesive compositions are used. The action of sclerosant in this case is aimed at the formation of an intravascular thrombus due to the inflammatory reaction of the intima of the vein and the development of connective tissue in place of the thrombosed varicose node. Along with the intravasal method of sclerotherapy, there is a paravasal method, which is based on the introduction of a sclerosant next to a vein, as a result of which compression of the varicose nodes occurs initially due to edema, and then due to the formation of connective tissue (Clinical recommendations for the treatment of bleeding from varicose veins of the esophagus and stomach / / National Clinical Recommendations of the Russian Society of Surgeons, Voronezh, 2014).

However, ES has disadvantages associated with the aggressive effect of sclerosing agents, including the formation of ulcers (up to 37%), with the possible formation of cicatricial stenosis of the esophagus, perforation of the esophagus, and mediastinitis. Complications often develop with injections into tissues than with intravasal sclerotherapy. In addition, the amount of sclerosant administered and the classification of cirrhosis by Child-Pugh are important. With intravasal administration of a solution of sclerosant, low efficiency is noted due to rapid flushing of the bolus volume of sclerosant with a blood stream with no vein thrombosis (S. Sherlock, J. Dooley. Diseases of the liver and biliary tract. M: GEOTAR, 1999. P. 224).

A known method of intravasal administration of microfoam of fibrovine into the lumen of the esophagus (Method for endoscopic sclerotherapy of varicose veins of the esophagus. RF Patent No. 2357700, IPC АВВ 17/94, publ. 10.06.2009, Bull. No. 16). The method involves the intravasal administration of a sclerosing agent into varicose veins of the lower third of the esophagus using a sclerosing probe. Before the procedure, an elastic balloon is coaxially attached to the distal end of the endoscope tube, which is placed in the lumen of the esophagus 3-4 cm above the intended injection site, filled with air, compressing the veins of the submucosal layer, and 5.0 ml of foam of a 3% fibrovane solution are injected within 1.5-2 minutes

This technique is described and applicable for the eradication of esophageal veins in a planned manner as a way of secondary prevention of varicose bleeding. Its disadvantages are the use in the "cold" period, that is, after stopping bleeding in other ways to prevent recurrence of bleeding, the use of a special balloon complicating the design, and the use of an endoscope.

Closest to the claimed is a method of intravasal administration of a solution of ethoxysclerol into the lumen of the esophagus vein. The method is as follows. In the projection of the abdominal segment of the esophagus, after puncture with an endoscopic injector, up to 2 ml of a 1-3% solution of ethoxysclerol is injected into the dilated venous trunk at the same time so that the last drop falls into the injection site. Then the procedure is repeated with other extended trunks. The total amount of sclerosant administered is up to 10-14 ml. The procedure requires repeated sessions with the introduction of a sclerosant above the primary injection points to increase the length of the thrombosed segment and improve the quality of eradication of the veins (Clinical recommendations for the treatment of bleeding from varicose veins of the esophagus and stomach // National Clinical Recommendations of the Russian Society of Surgeons, Voronezh, 2014).

The disadvantages of the method are both unsatisfactory efficiency in thrombosis of the vein and its obliteration due to unpredictable contact of the sclerosant with the perimeter of the endothelium of the vein, and a high risk of severe complications requiring surgical treatment, necrosis of the esophagus wall at the injection site, mediastinitis, necrosis of the liver, spleen , stomach, heart attack pneumonia. The toxic effect of the drug is also known, which, when the recommended volume is exceeded, causes systemic complications.

The objective of the invention is to develop an affordable, effective and safe method of primary sclerosing hemostasis at the height of varicose bleeding.

The problem is achieved by the method of primary sclerosing hemostasis with active bleeding from varicose veins of the esophagus, including the intravasal introduction of microfoam ethoxysclerol into the lumen of the vein of the esophagus.

Prepare microfoam by mixing 3% ethoxysclerol with air in a ratio of 1: 6 or 1% ethoxysclerol in a ratio of air 2: 6 and inject the resulting 7-8 ml of ethoxysclerol microfoam through an injector into the lumen of a bleeding vein of the esophagus or stomach 1.5 cm proximal to the bleeding source , if necessary, make repeated injections into other dilated veins, additionally add 2 ml of 1% hydrogen peroxide solution at the cardia level on each side of the vein, submucosally submucosally, hemostasis is controlled after 8-12 hours, if necessary the procedure is repeated after 6 days, 1, 3, 6 months.

Novelty of invention

- Prepare microfoam by mixing 3% ethoxysclerol with air in a ratio of 1: 6 or 1% ethoxysclerol in a ratio of air 2: 6 and inject the resulting 7-8 ml of microfoam ethoxysclerol through an injector into the lumen of a bleeding vein of the esophagus or stomach 1.5 cm proximal to the source bleeding. The ratio of the volume of the solution of sclerosant and air is 1: 6 and 2: 6, which allows to increase the safe volume of microfoam to 7-8 ml (more than double compared to the prototype). The method is used at the height of bleeding in order to achieve hemostasis, and the effect of sclerotherapy is secondary for the prevention of recurrence of bleeding. This endoscopic stop of varicose esophageal bleeding with simultaneous sclerotherapy is achieved by using ethoxysclerol as a sclerosant, not a solution, but microfoams. At the same time, the amount of aggressive sclerosing substance decreases, and, consequently, the possible side effects of the active substance, its effectiveness increases due to the wide area of contact between the sclerosant and the vessel endothelium. Increasing the efficiency and length of the treated segment of the vein contributes to the bleeding itself, reducing the pressure in the vein and its diameter, which actually increases the contact area of the resulting microfoam volume, including by facilitating the eradication of the nearest veins of the stomach and preventing bleeding from them.

- In addition, 2 ml of a 1% hydrogen peroxide solution at the level of the cardia on each side of the vein is paralyzed submucosally. This enhances the external compression of the vein and additionally increases the length of the segment damaged by the sclerosant, contributes to the convergence of the walls of the vein and shorten the terms of its obliteration.

- Control of hemostasis is performed after 8-12 hours, if necessary, the procedure is repeated after 6 days, 1, 3, 6 months.

The set of essential features of the invention allows to obtain a new technical result:

1. The method allows you to effectively stop bleeding from varicose veins of the stomach.

2. Endoscopic arrest of varicose esophageal bleeding is achieved with simultaneous sclerotherapy.

3. The application of the method at a height of bleeding from the veins of the esophagus contributes to the eradication of the nearest varicose veins of the stomach and prevents bleeding from them.

4. A significantly larger volume of microfoam is used than sclerosant in liquid form for simultaneous exposure of the esophagus and stomach veins.

Thus, the method of endoscopic primary sclerosing hemostasis is simple to use, effective, reduces the time spent on the prevention of bleeding, is safe.

The invention is illustrated by photographs of the patient described in the example shown in FIG. 1-6.

In FIG. 1 - jet bleeding from varicose veins in n / 3 of the esophagus.

In FIG. 2 - an injector is removed into the lumen of the esophagus.

In FIG. 3 - needle injection is 1.5 cm proximal to the source of bleeding.

In FIG. 4 - microfoam of ethoxysclerol is introduced.

In FIG. 5 - bleeding stopped.

In FIG. 6 - control on the 4th day. In the area of the introduction of sclerosant, a surface defect with fibrin, the vein is sclerosed.

The method is as follows. If varicose bleeding is detected during esophagogastroduodenoscopy, a microfoam of 3% ethoxysclerol is prepared directly at the table in a ratio of 1: 6 with air according to the Tessari method: two syringes, in one of which 1.0 ml of ethoxysclerol is collected, and in the other 6.0 ml of air, are combined three-way adapter, then microfoam is beaten by rhythmic sequential movement of the contents of the syringes from one to another, it is necessary to perform 20 such movements. Microfoam is prepared similarly from 2 ml of 1% ethoxysclerol in a ratio of 2: 6 with air. The needle of the endoscopic injector needle is 1.5 cm proximal to the visible defect - blood stream from the vein, then the entire contents of the syringe 7-8 ml of microfoam is injected into the vein through the injector. An indicator of the correct introduction of microfoam is the expansion of the vein to the level of the cardia and distal and the appearance of microfoam through a bleeding defect in the vein. If necessary, the procedure is repeated, while the amount of ethoxysclerol administered should not exceed the permissible norm of 2 ml / kg body weight (for a person weighing 70 kg, up to 14 ml of a 1% solution, up to 4.6 ml of a 3% solution) (Encyclopedia of Medicines. 23rd Issue / Gl.red.G.L. Vyshkovsky.M.: RLS-2015, 2014. 1392 p.). Removing the needle of the injector is carried out in the process of introducing the last milliliter of microfoam. To enhance vein compression and control bleeding, 2 ml of a 1% hydrogen peroxide solution is administered paravasally submucosally at the cardia level on each side of the vein. Re-examination is carried out after 8-12 hours, if necessary, the procedure is repeated, further control of esophagogastroduodenoscopy and repeated injections of microfoam are carried out sequentially after 6 days, 1, 3, 6 months.

The method is used to stop bleeding in 5 patients. In all cases, it was possible to achieve effective hemostasis. Relapse of bleeding occurred in 1 patient from another vein, was also successfully resolved.

Clinical example. Patient M., 36 years old, was hospitalized on an emergency basis 10/16/2012 with complaints of vomiting of blood, weakness. With endoscopy revealed jet bleeding in the lower third of the esophagus from varicose veins, on the left wall. Performed intravasal administration of microfoam ethoxysclerol with a total volume of 21.0 ml (3 ml of 3% ethoxysclerol). Bleeding is stopped. Performed a paravasal submucosal infiltration of 1% hydrogen peroxide in 2.0 ml at the level of the cardia on each side of the vein. Control of hemostasis after 8-12 hours. With a control endoscopy after three days at the injection site of microfoam, surface defects with fibrin are present. The vein is sclerosed. On the 6th day, a defect with fibrin in the projection of the left wall persists, intravasal sclerotherapy with microfoam ethoxysclerol 14.0 ml (2 ml ethoxysclerol) of the venous trunk located on the right wall was performed. There are no complications. The patient was discharged on the 7th day of hospitalization.

Claims (1)

The method of primary sclerosing hemostasis with active bleeding from varicose veins of the esophagus and stomach, including the intravasal injection of 1-3% ethoxysclerol into the lumen of the esophagus, characterized in that microfoam is prepared by mixing 3% ethoxysclerol with air in a ratio of 1: 6 or 1% ethoxysclerol with air in 2: 6 ratio and the obtained 7-8 ml of microfoam is injected through the injector into the lumen of a bleeding vein of the esophagus or stomach 1.5 cm proximal to the bleeding source, if necessary, repeat injections, additionally paravasal 2 ml of a 1% hydrogen peroxide solution at the cardia level on each side of the vein is submucously injected, hemostasis is monitored after 8-12 hours, the procedure is repeated if necessary, later esophagogastroduodenoscopy is monitored and microfoams are re-injected sequentially after 6 days, 1, 3 , 6 months.

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