Application of Endoscopic Sorption Insufflations in the Complex Treatment of Erosive-Ulcerative Lesions of the Upper Gastrointestinal Tract Complicated by Bleeding

The dissertation is dedicated to the development and implementation of methods for the complex treatment of erosive-ulcerative lesions of the upper gastrointestinal tract complicated by bleeding. The study investigates the efficacy of endoscopic sorption insufflations based on a biologically active granular sorbent, Divin, as well as the possibilities of using the immunomodulator Immunofan in combination with endoscopic therapy. The state of immune reactivity of patients with acute gastroduodenal hemorrhages was studied, and indications for immunocorrection were substantiated. Patents for inventions related to methods of endoscopic hemostasis and a device for the administration of medicinal substances were obtained.

Relevance of the problem. One of the urgent problems of emergency surgery is the treatment of erosive-ulcerative lesions of the upper gastrointestinal tract complicated by bleeding. The frequency and prevalence of erosive-ulcerative lesions of the gastroduodenal zone range from 5% to 15%, and by the number of outpatient referrals, this pathology ranks third among all diseases of the digestive organs in the adult population [12,13,16,30,50,68,80,96,145,156,208].

Today, the question of whether erosion is a pre-ulcerative condition or an independent nosological form remains a matter of discussion. Erosive lesions of the stomach and duodenum, as noted by a number of researchers, are a facultative pre-ulcerative condition capable of transforming into an ulcer, a defect, or combining with it [30,31,36,51,99,117,132,136,138,159].

At present, gastrointestinal hemorrhages are the most formidable complication of erosive-ulcerative lesions of the gastroduodenal area [17,68,69,75,88,90,99,163]. They occur in 15–28.6% of patients. Ulcer hemorrhages are encountered in 54.3%–78.5% of cases [43,87,91,96,107,111,137,138,155], while non-ulcer hemorrhages account for 25%–33.9% [30,50,80,87,99,117,132,159].

Acute gastrointestinal hemorrhages lead to the development of secondary immunodeficiency, the severity of which is directly dependent on the degree of blood loss sustained [8,20,73,97,100,109]. However, data in the literature on the state of immune status and its significance in the outcome of treatment of patients with gastroduodenal hemorrhages are scarce and contradictory [8,20,44,73,100,114].

The choice of treatment strategy for acute gastroduodenal hemorrhages always presents a complex task for every surgeon providing emergency care. While surgical indications for patients with ulcerous gastrointestinal hemorrhages should be expanded, according to the majority of surgeons, conservative treatment is most often conducted for patients with non-ulcer hemorrhages [12,13,21,30,68,96,99,107,138,208].

Achieving rapid healing of ulcer defects means eliminating a possible source of complications or substantially reducing the risk of their occurrence [69,92,96,99,132,137,162,180].

The use of general hemostatic therapy, effective antisecretory agents (H2-blockers, proton pump blockers, somatostatin analogs), and the widespread introduction into clinical practice of various methods of endoscopic hemostasis (irrigation, electrocoagulation and photocoagulation with a laser beam, infiltration, clipping) makes it possible to achieve cessation of gastroduodenal bleeding in 85%–95% of patients [31,42,47,50,68,99,117,122,138,165,208]. However, the recurrence rate of acute gastroduodenal ulcer hemorrhages remains high, reaching 12%–35% in cases of duodenal localization and exceeding 40% with gastric ulcer localization. The proportion of patients with recurrent gastroduodenal ulcer hemorrhages among all those who died from gastroduodenal hemorrhage amounts to 60%–80% [30,31,42,47,50,80,111,138,208].

All of this justifies the search for new agents and the refinement of known pathogenetically grounded methods of treatment of gastroduodenal hemorrhages.

The method of endoscopic treatment of ulcer disease by insufflation of a gel sorbent appears promising [121]. However, the influence of biologically active granular sorbents of a new generation on the course of erosive-ulcerative processes of the gastroduodenal zone has not been investigated, and the efficacy of Divin in stopping ulcer hemorrhages has not been studied. There remains heightened interest in the functioning of the immune system in acute gastroduododenal hemorrhages, the importance of evaluating the dynamics of immune parameters from the standpoint of pharmacological correction and optimization of the timing of surgical interventions in patients with ulcerous gastrointestinal hemorrhages, and the questions on the use of Divin and immunocorrectors in the complex treatment of erosive-ulcerative gastrointestinal hemorrhages have not received further coverage.

Objective of the research. To improve the outcomes of treatment of patients with erosive-ulcerative lesions of the upper gastrointestinal tract complicated by bleeding through the use of endoscopic sorption insufflations and the immunocorrector Immunofan as important components of complex therapy.

Tasks of the research.

1. To evaluate the appropriateness and efficacy of using the sorbent of a new generation, Divin, in erosive-ulcerative lesions of the gastroduodenal zone complicated by hemorrhage.

2. To study the state of immune reactivity of patients with acute erosive-ulcerative gastrointestinal hemorrhages, to investigate the dynamics of immune parameters depending on the degree of bleeding and the therapy conducted.

3. To develop a methodology for the use of Immunofan in complex therapy of gastroduodenal hemorrhages.

4. To conduct a comparative evaluation of the efficacy of treatment of erosive-ulcerative gastroduodenal hemorrhages by traditional methods and with the inclusion of endoscopic sorption therapy and the immunomodulator Immunofan in the complex of measures.

5. To develop practical recommendations for the use of the proposed complex method of treatment of erosive-ulcerative lesions of the gastroduodenal zone complicated by bleeding.

Novelty of the scientific research. The possibility of effective use of the biologically active draining sorbent of a new generation, Divin, for endoscopic treatment, local hemostasis, and endoscopic prevention of recurrence of erosive-ulcerative gastrointestinal hemorrhages has been investigated and clinically demonstrated.

The hemostatic action of Divin and its positive influence on the course of the reparative process of erosive-ulcerative lesions of the stomach and duodenum complicated by bleeding have been determined (Rationalization proposals No. 5015, 5016, 5017, 5018 dated May 18, 2005).

The dynamics and degree of immune disorders in patients with gastroduodenal hemorrhages have been studied.

Based on the evaluation of immune reactivity parameters in patients with this nosology, indications for including the immunomodulating agent Immunofan in complex therapy of patients with gastrointestinal hemorrhages have been developed.

A simple and effective method of endoscopic hemostasis of the rupture-hemorrhagic syndrome through insufflation of the hydrophilic granular sorbent Divin has been developed, and the possibility of its use in the complex treatment of ulcer gastroduodenal hemorrhages has been demonstrated (Patent for Invention No. 2256452).

A device for the endoscopic administration of medicinal substances for the local treatment of erosions and ulcers of the stomach and duodenum has been used for the first time (Patent for Invention No. 2260448).

The appropriateness of applying endoscopic sorption therapy in combination with the immunomodulator Immunofan in patients with acute erosive-ulcerative gastrointestinal hemorrhages has been demonstrated.

Practical significance of the work. The use of the biologically active draining sorbent of a new generation, Divin, has made it possible to improve the outcomes of treatment of patients with erosive-ulcerative lesions of the upper gastrointestinal tract complicated by bleeding.

The application of the proposed method has made it possible to reduce the number of therapeutic endoscopies, decrease the frequency of complications, and obtain a social and economic effect.

The conducted studies of the immune status of patients with gastrointestinal hemorrhages have made it possible to identify immune disorders in this category of patients.

The methodology of immunocorrection in combination with endoscopic treatment with a draining sorbent is available for use in any medical institution, is simple in practical terms, and requires no additional expenditures.

Principal provisions for defense.

The hydrophilic granular sorbent of a new generation — Divin, upon local treatment of erosions and ulcers of the upper gastrointestinal tract, transforms into a soft elastic gel layer and performs the role of an endoprotector, effectively protecting them from the action of the acid-peptic factor. This promotes rapid healing of defects and elimination of sources of bleeding.

Acute blood loss leads to disruption of the immune status of patients with gastroduodenal hemorrhages.

The application of intraluminal sorption therapy in combination with immunotropic agents (Immunofan) increases the reliability of hemostasis, reduces the number of bleeding recurrences, leads to positive changes in the immune system, and shortens the duration of treatment of patients.

Implementation of the principal provisions.

The principal provisions of the work have been implemented in the work of the Voronezh City Center for the Treatment of Patients with Gastrointestinal Hemorrhages based on MUZ GO Voronezh, GKB SMK No. 1.

The methodology of complex studies of the systemic immune status in patients with acute gastroduodenal hemorrhages has been implemented in the work of the surgical department No. 1 of MUZ GO Voronezh GKB SMK No. 1.

The developed device for the administration of medicinal substances (Patent for Invention No. 2260448 dated 20.09.2005) is used in the local treatment of erosions and ulcers of the stomach and duodenum in the endoscopic department of MUZ GO Voronezh GKB SMK No. 1.

The research results, exclusive video materials, are used in lectures and practical sessions at the Department of Faculty Surgery of VGMU named after N.N. Burdenko.

Validation of the work. The principal provisions of the dissertation were reported and discussed at the 4th Congress of the Scientific Society of Gastroenterologists of Russia (Moscow, 2004), the 8th and 9th International Congresses of Endoscopic Surgery (Moscow, 2004, 2005), the International Surgical Congress "New Technologies in Surgery" (Rostov, 2005), at the first congress of surgeons of the Southern Federal District (Rostov, 2007), and at an interdepartmental seminar with the participation of departments of faculty, general, hospital, pediatric, and operative surgery (Voronezh, 2007).

Publications.

Based on the results of the conducted research, 7 scientific articles have been published in central journals and publications, in journals listed by the VAK, in collections of proceedings of international and all-Russian conferences. Patents for Invention "Method for the Treatment of Mallory-Weiss Syndrome," "Device for the Administration of Medicinal Substances," and 4 certificates of rationalization proposals have been obtained.

Structure and volume of the work.

The dissertation consists of a table of contents, introduction, literature review, description of clinical material and research methods, a chapter of original research, conclusion, findings, practical recommendations, and a bibliography. The main text is presented on 110 pages, illustrated with 7 figures and 11 tables. The bibliography includes 212 domestic and foreign sources.

Basic data on the presented work.

The work was completed at the Department of Faculty Surgery (head — D.M.N., Professor E.F. Cherednikov), based at MUZ GO Voronezh GKB SMK No. 1 (chief physician — Honored Doctor of the Russian Federation G.I. Zimarin), Voronezh State Medical Academy named after N.N. Burdenko (rector — D.M.N., Professor I.E. Yesaulenko).