CC BY
10
DOI 10.26724/2079-8334-2019-2-68-135-140 UDC 616.329-089
O.Yu. I M'liko. A.V Sydiuk. A.S. Mimas. O.Ye. Sydiuk Shalimov s National Inslilule of Surggery and Transplantology. Kyiv
POSTOPERATIVE ANASTOMOTIC COMPLICATIONS IN PATIENTS WITH MALIGNANT TUMORS OF THE ESOPHAGUS AND ESOPHAGEAL GASTRIC JUNCTION CANCER
e-mail: klimas.andrew@gmail.com
Formation of esophagogastric anastomosis after esophagectomy, despite apparent progress, is still accompanied by the development of complications associated with anastomosis. However, information about the impact of the method of forming esophagogastric anastomosis on the effects after the esophagectomy remains controversial. The aim of the study - to provide a comparative characteristic of postoperative complications in patients after esophagectomy, depending on the method of forming the mechanical esophagogastric anastomosis. The study included 30 patients who were formed by developed and protected by the Ukrainian patents invagination mechanical esophagogastroanastomosis (study group) and 30 patients who had formed circular mechanical esophagogastroanastomosis end-to-side (comparison group) after esophagectomy. Evaluated the rate of anastomotic leakage, the frequency of benign strictures, the frequency and severity of reflux esophagitis. In the dynamics all patients performed esophagogastroduodenoscopy, the severity of the reflux esophagitis was evaluated according to the modified Los Angeles classification. Statistical analysis of data was carried out using the statistical analysis package EZR v. 1.35 (Saitama Medical Center, Jichi Medical University, Saitama, Japan), Graphic interface to R (The R Foundation for Statistical Computing, Vienna, Austria). In the conditions of the formation of invagination mechanical esophagogastroanastomosis, the results revealed a statistically significant reduction in benign strictures (p=0,047) (17% (95% CI 5,4% - 32,6%), vs 43% (95% CI 25,7% - 61,9%), RF=0,4 (95% CI 0,2 - 0,9), as well as the frequency of postreaction reflux esophagitis (43% vs 68%; p=0,02) in comparison with the circular mechanical esophagogastroanastomosis end-to-side. However, there were no significant differences between the two groups regarding the anastomotic leakage (0% vs 7%, p=0,49). It should be noted that in the conditions of the formation of invagination mechanical esophagogastroanastomosis cases of its leakage were not revealed. The method of formation of the invagination mechanical esophagogastroanastomosis contributes to the reduction of the frequency of benign strictures of anastomosis and reflux esophagitis, anastomotic leakage was not observed.
Keywords: mechanical anastomosis, invagination, circulatory, anastomotic leakage, benign stricture, reflux esophagitis.
The work is a fragment of the research project "Improving the Methods of Surgical Treatment and Postoperative Anesthesia in Patients with Esophageal Diseases", state registration No. 0117U007505.
Esophageal cancer, being a multifaceted and complex disease, which puts increasing social and financial burdens on global health systems [14], is marked by aggressiveness [9], low survival rate of patients [7, 22], high mortality and postoperative complications after the esophagectomy [8] and requires further development aimed at improving the consequences of operational intervention [8].
The standard of treating resectable esophageal cancer and some benign illnesses of the esophagus is neoadjuvant chemotherapy or chemoradiotherapy with an open, transthoracic esophagectomy [14]. The success of esophagectomy, besides the experience of a surgeon [1], is largely determined by the reliability of the created esophagogastroanastomosis [12]. Despite the presence of a large number of variants of esophagogastroanastomosis in the location, the way of formation and the peculiarities of the technique of execution, the search for "ideal" esophagogastroanastomosis continues to this day. Almost all known methods of anastomosis technique have their specialized advantages and disadvantages, and such important major complications after esophagectomy as the anastomotic leakage, the formation of benign strictures and gastroesophageal reflux disease can endanger the quality of life of patients and even be directly hazardous to life [15]. Scientific discussions focus on questions about the observed contribution of each method to the frequency of the above complications and the results of at least 3-month mortality. Creation of functionally complete anastomosis with a minimal amount of postoperative complications by this time remains one of the most important issues of esophageal surgery [3]. According to Law D. E. [11], the key to success is the development of new methods aimed at improving the quality of intrathoracic anastomosis after esophagectomy, and clinical studies to compare the different ways of forming EGA in terms of reducing the level of development of late complications from the anastomosis [12].
An analysis of the literature from the above-mentioned problems suggests that most surgeons around the world use mechanical techniques to form a thoracic anastomosis [1, 12, 14]. The development and implementation of surgical suturing devices in the clinical practice has become an important contribution to esophageal surgery, as the time for their implementation was reduced, the accuracy of the crosslinked tissue, aseptic, durability and tightness of the seam, the reliability of the formation of the esophagointestinal and gastroesophageal anastomoses was increased. All this greatly improved the results of esophagoectomy and esophagoplasty [1]. Due to the introduction of a mechanical (staple) method for the formation of esophagogastroanastomosis, the frequency of anastomotic leakage has decreased
© O.Yu. Usenko, A.V. Sydiuk, 2019
compared to the manual method of formation. However, the mechanical (staple) method of forming the esophagogastroanastomosis end-to-back increases the risk of the formation of anastomotic benign strictures [10]. Consequently, along with convincing advantages, the use of stapler devices somewhat impairs the functional results of operations due to the high level of development of late complications from anastomoses: inflammatory complications (anastomositis, reflux esophagitis) and benign strictures [7, 10]. We did not find any studies to compare different ways of forming mechanical anastomosis.
The purpose of the study was to provide comparative description of postoperative complications associated with anastomosis in patients after esophagectomy depending on the method of forming a mechanical esophagogastroanastomosis.
Table 1
Clinical and demographic profile of patients
Characteristic Groups Total, n=60 P
research, n=30 comparison, n=30
abs. % abs. % abs. %
Age
41 - 50 4 13 5 16 9 15 0,19
51 - 60 12 40 11 36 23 38
61 - 70 14 46 10 33 24 40
more than 70 0 - 4 13 4 7
Sex
Female 5 17 3 10 8 13 0,45
Male 25 83 27 90 52 87
Histologic type of tumors
Adenocarcinoma 15 50 15 50 30 50 >0,99
Squamous cell carcinoma 15 50 15 50 30 50
Localization
Middle third of the esophagus 13 43 12 40 25 42
lower third of the esophagus 2 7 3 10 5 8 0,89
Esophagogastric junction 15 50 15 50 30 50
Distribution of patients according to Siewert's classification
Type I 2 12 3 17 5 14 0,95
Type II 15 88 15 83 30 86
Type III 0 - 0 - 0 -
Distribution of patients by TNM classification
T1 0 - 0 - 0 - 0,54
T2 1 3 2 7 3 5
T3 14 47 17 57 31 52
T4 15 50 11 37 26 43
N0 14 47 14 47 28 47 0,91
N1 12 40 12 40 24 40
N2 2 7 3 10 5 8
N3 2 7 1 3 3 5
M0 28 93 28 93 56 93 >0,99
M1 2 7 2 7 4 7
Stage of the disease
I st. (IA, IB) - - 1 3 1 2 0,95
II st. (IIA, IIB) 12 40 10 33 22 37
III st. (IIIA, IIIB, IIIC) 16 53 17 57 33 55
IV st. 2 7 2 7 4 6
Access o étions
Ivor Lewis 14 47 15 50 29 48 0,8
Osawa-Garlock 16 53 15 50 31 52
Chemoradiotherapy 15 50 15 50 30 50 >0,99
Chemotherapy 15 50 15 50 30 50
Comorbidity
CHD. Angina pectoris II-III FC. HF IIA-B st. 5 17 7 23 12 20,0 >0,05
CHD. Postinfarction cardiosclerosis. HF IIA-B st. 4 13 3 10 7 12
CHD. Atherosclerotic cardiosclerosis. HF IIA-B st. 13 43 15 50 28 47
CHD. Extrasystolic arrhythmia and atrial fibrillation. HF IIA-B st. 7 23 5 17 12 20
Arterial hypertension II-III st. 24 80 22 73 46 77
COPD Respiratory Insufficiency I-II st. 19 63 18 60 37 62
Materials and methods. The study included 60 patients operated in Shalimov's National Institute of Surgery and Transplantology with regard to malignant tumors of the esophagus and esophagogastric junction, which have undergone radical surgical intervention (Proximal gastric resection with esophagectomy by Ivor Lewis and Osawa-Garlock accesses). The diagnosis of cancer has been verified morphologically before surgery. On the basis of analysis of medical cards and protocols of surgical procedures, results of endoscopic and histological examination, information on the characteristics of tumors, surgical interventions and complications are collected.
The study included 30 patients who were formed by developed and protected by the Ukrainian patents [4] and implemented in a clinical practice by a team of employees of Shalimov's National Institute of Surgery and Transplantology invagination mechanical esophagogastroanastomosis (IM EGA) [4]. The comparison group also included 30 patients who developed end-to-side circular mechanical esophagogastroanastomosis after the esophagectomy (CM EGA). The oncology process was exposed using the international classification of malignant tumors "TNM" 7 edition for malignant tumors of the esophagus and esophagogastric junction.
We have analyzed the clinical and demographic profile of the patients being studied, since in the scientific literature from time to time there are publications about the risk factors of complications after esophagectomys, both in general [13], and related directly to anastomosis in order to determine the comparability of the studied groups (table 1).
Since we wanted to detect anastomosis-related complications that could potentially affect the postoperative period in a clinically meaningful way, we only evaluated the incidence of esophagogastroanastomosis leakage, the frequency of benign strictures, the frequency and severity of reflux esophagitis. The fact of esophagogastroanastomosis leakage was fixed by X-ray examination, esophagogastroduodenoscopy (EGDS) and clinical manifestations. EGDS is performed for all patients in the dynamics of 3, 6 and 12 months of observation. Endoscopic examination of the presence of postoperative benign strictures of esophagogastroanastomosis and endoscopic manifestations of reflux esophagitis was performed by video gastroscope Olympus GIF-H180. In dubious cases of reflux esophagitis diagnostics, virtual chromoscopy NBI was used. The endoscopic severity of reflux esophagitis was evaluated according to the modified Los Angeles classification. The study was conducted in compliance with the principles of bioethics. Data Processing. Statistical analysis of data was carried out using the statistical analysis package EZR v. 1.35 (Saitama Medical Center, Jichi Medical University, Saitama, Japan), Graphic interface to R (The R Foundation for Statistical Computing, Vienna, Austria). To test the distribution of indicators for normality, the criterion of Shapiro-Wilk was used. To analyze the differences between groups of quantitative (and rank characteristics), the Mann-Whitney criterion was used. For the analysis of the differences in qualitative characteristics, the %2 criterion or Fisher's exact criterion is used for tables 2^2. To analyze the dynamics of the indicators, Friedman's criterion was used for repeated measurements; pair comparisons were conducted according to the Conover criterion. To analyze the dynamics of complications, we used the method of constructing survival curves (Kaplan-Meier survival analysis) [6].
Table 2
Clinical and laboratory profile of patients
Characteristic Groups P
research, n=30 comparison, n=30
BMI 23,0 (22,2-24,9) 21,8 (19,6-24,7) 0,20
Total protein g/l 65,2 (62,9-74,1) 67,0 (64,4-70,3) 0,94
Albumin g/l 39,6 (37,6-42,6) 39,4 (37,6-41,6) 0,34
Operation time 4,3 (4,2-5,2) 4,4 (4,2-5,3) 0,38
Notes: Median Me value and Interquartile swing (QI-QIII) are presented.
Results of the study and their discussion. A detailed analysis of patients' clinical and demographic, clinical and laboratory profile (table 1, 2) was conducted with one purpose - to achieve the maximum objectivity and comparability of estimated post-resection results associated with anastomosis, which is achieved under the condition of homogeneity of the comparable groups of patients at risk factors. The etiology of the development of anastomotic leakage and the formation of benign stricture is due, according to the literature, by many factors. Thus, the formation of strictures is associated with excessive effects of gastric acid, subclinical leakage, pressure levels and local anastomosis ischemia [75]. The factors contributing to the leakage of anastomosis include the personality factors of the patient [4, 14]; technical factors [4, 14] and postoperative factors [19]. Since most of the above factors were taken into account and
no reliable differences were found between the comparable groups of patients, we obtained a statistically well-founded argument in favor of the fact that the differences between the groups for the complications associated with anastomosis will be conditioned solely with the used methods of formation of esophagogastroanastomosis.
Results of the reflux esophagitis manifestation in the dynamics are shown in table 3.
Table 3
Endoscopic manifestations of reflux esophagitis
Severity of reflux Research group, abs. (%), (n=30) Comparison group, abs. (%), (n=30) p
esophagitis Absent LA-A LA-B LA-C Absent LA-A LA-B LA-C
3 moth. 12 10 8 0 5 11 12 2 0,03
(40) (33) (27) (0) (17) (37) (40) (7)
6 moth. 12 13 5 0 5 16 8 1 0,046
(40) (43) (17) (0) (17) (53) (27) (3)
12 moth. 17 10 3 0 7 18 5 0 0,02
(57)*# (33) (10) (0) (23)*# (60) (17) (0)
P 0,001 0,002
Notes: Mann-Whitney's criterion was used to analyze the differences between the groups. To analyze the dynamics of the indicators, Friedman's criterion was used for repeated measurements; pair comparisons were performed according to the Conover criterion (Conover, 1999); * - the difference from the indicator at the time of 3 months is statistically significant (p<0,05); # - the difference from the indicator at the time of 6 months is statistically significant (p<0.05).
On the 3rd (p=0,03) and the 6th (p=0,046) months, estimates for the presence / absence of reflux esophagitis were different: in 40% of the patients in the study group and only in 17% of the patients in the comparison group, reflux esophagitis was not found out Accordingly, the frequency of reflux esophagitis was significantly higher in the group of patients, which was formed by CM EGA compared with the MI EGA (60% vs. 83%). In this case, severe reflux esophagitis (LA-C) was not observed in the study group, while in the comparison group, 2 cases of severe reflux esophagitis (Table 3) were observed.
On the 6th month of the assessment, compared to the 3rd month, both groups showed an increase in the number of patients with reflux esophagitis LA-A degree (10% more in the study group and 20% in the comparison group) and their decrease with more severe degrees of reflux esophagitis (LA-B) (10% in the study group and 13% in the comparison group). There were no cases of reflux oesophagitis LA-C in the study group, with a reduction in the reflux-esophagitis LA-C of 3% in the comparison group. At the 12th month of observation, the number of patients without reflux esophagitis was higher in the study group (57% vs. 23%). In the total number of patients with reflux esophagitis, the best results were obtained in the study group compared to the comparison group (43% vs. 68%; p=0,02). At the same time, for the 12th month, compared with the 6th month, the reflux-esophagitis LA-A was registered 10% less in the study group, while in the comparator group, the tendency towards its growth continues to grow (more than 7%). There was a steady tendency to reduce the more severe manifestations of reflux esophagitis, as reflux esophagitis LA-B in the study group decreased by 7%, and in the comparison group - by 10%, cases of reflux esophagitis LA-C were not registered. Thus, in assessing the dynamics of distribution of patients in terms of severity of reflux esophagitis both in the study group (p=0,001) and in the comparison group (p=0,002), there was a decrease in its severity throughout the evaluation period. In both groups, the degree of severity of reflux esophagitis was lowest at 12 months of follow-up (Table 3). The comparative analysis of the distribution of values according to severity of reflux esophagitis between the study group and the comparison group by the Mann-Whitney criterion showed significantly lower values in the group of patients who formed an invagination mechanical
j_i_i
4 6 8 10
Time, month
Fig. 1. Evaluation of the risk of developing benign strictures.
esophagogastroanastomosis during the entire assessment period (p=0,03, p=0,046, p=0,02) (Table 3). We believe that such a decrease in the severity of manifestations of reflux esophagitis is associated with the administration of proton pump inhibitors.
One of the known complications of esophageal cancer surgery is the formation of benign strictures. The total number of postoperative benign strictures during the year of follow-up in the study group was lower (p=0,047) and amounted to 5 (17%) (95% CI 5,4% - 32,6%), and in the comparison group - 13 (43%) (95% CI 25,7% - 61,9%), RF=0,4 (95% CI 0,2-0,9). To analyze the dynamics of postoperative benign strictures, we used the method of constructing Kaplan-Meyer's survival curves [16]. At the same time, when comparing the Lorgang criterion, the risk of development of benign strictures was significantly higher in the comparison group (p=0,02), HR=3,1 (95% CI 1,2-8,2) (Fig. 1).
An increase in the number of cases of benign strictures of esophagogastroanastomosis in patients with CM EGA was associated with a more severe reflux esophagitis in these patients, which causes a persistent inflammatory process in the region of esophagogastroanastomosis and leads to the formation of benign strictures. All cases of benign strictures were corrected by endoscopic balloon hydrodilation.
Esophagogastroanastomosis leakage is one of the most formidable postoperative complications in patients after esophagectomy, and according to Birkmeyer J. D. et al. [1], the 5-year survival rate of patients may be reduced by 20%. During the analysis of the number of cases of anastomotic leakage, no statistically significant difference was found between the two groups of patients, however, in the study group, anastomotic leakage was not fixed (0% vs. 7%, p = 0,49). According to the literature, the average anastomotic leakage is 6-21% [3, 11]. In conclusion, this study demonstrates that anastomosis-related complications, such as reflux esophagitis and benign strictures, are a direct consequence of the formation of a mechanical EGA.
IIIIIIIÉCOnÉÍÉÉB
1. Invagination mechanical esophagogastroanastomosis in comparison with circular mechanical esophagogastroanastomosis end-to-back is more effective with respect to a significant decrease in the number of postoperative complications such as post-resection reflux esophagitis and benign strictures in patients after esophagectomy. It is reliable because anastomotic leakage was not observed.
2. Since complications after esophagectomy as a whole and related to anastomosis are those factors that increase the use of resources and costs in the surgical treatment of esophageal cancer, affect the quality of life of patients and the very life, we consider it necessary to inform the medical community about the effectiveness of the proposed a method for the formation of invagination mechanical EGA.
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1>еферп ni
тСЛЯОПЕРАЦШШ УСКЛАДНЕННЯ З БОКУ АНАСТОМОЗУ У ХВОРИХ З1 ЗЛОЯК1 СНИМИ НОВОУТВОРЕННЯМИ СТРАВОХОДУ ТА КАРДЮЕЗОФАПАЛЬНОГО
ПЕРЕХОДУ Усенко О.Ю., Сидюк А.В., КМмас А. С., Сидюк О.С.
Формування стравохщно-шлункових aHacT0M03iB тсля езофагектомп, не дивлячись на явний прогрес, все ще супроводжуеться розвитком у пащенив ускладнень, пов'язаних з анастомозом. Однак тформащя щодо впливу способу формування езофагогастроанастомозу на наслщки тсля езофагектомп залишаеться суперечливою. Мета роботи - надати порiвняльну характеристику пост-операщйних ускладнень у хворих тсля резекцп стравоходу залежно вщ способу формування мехатчного езофагогастроанастомозу. У дослщження включен 30 пащенив, яким було сформовано розроблений i захищений патентом Укра'ти швагтацтний мехатчний езофагогастроанастомоз (група дослiдження) i 30 хворих, яким було сформовано циркулярний мехатчний езофагогастроанастомоз юнець-в-бк (група порiвняння) тсля езофагектомп. Ощнювали частоту неспроможностi
езофагогастроанастомозу, частоту рубцевих стриктур, частоту та виражетсть рефлюкс-езофагiту. У динамщ усiм хворим проведена фiброезофагогастро-дуоденоскотя, ендоскопiчне дослiдження, вираженiсть рефлюкс-езофагiту ощнювали вщповщно до модифжовано! Лос-Анджелесько! класифкацп. Статистичний аналiз даних проведений з використанням пакету статистичного аналiзу EZR v. 1.35 (Saitama Medical Center, Jichi Medical University, Saitama, Japan), графiчний штерфейс до R (The R Foundation for Statistical Computing, Vienna, Austria). В умовах формування твапнащйного мехатчного езофагогастроанастомозу результати виявили статистично значуще зниження стриктур анастомозу (p=0,047) (17% (95% В1 5,4% - 32,6%), проти 43% (95% В1 25,7% - 61,9%), ВР=0,4 (95% В1 0,2 - 0,9), а також частоту пострезекщйного рефлюкс-езофапту (43% проти 68%; p=0,02) порiвняно з циркулярним мехатчним езофагогастроанастомозом кiнець-в-бiк. Однак мiж двома групами не було виявлено ютотних вщмшностей щодо неспроможностi анастомозу. Зазначимо, що в умовах формування твапнащйного мехатчного езофагогастроанастомозу випадюв його неспроможност не було виявлено (0% проти 7%, p=0,49). Спосiб формування твапнащйного мехатчного езофагогастроанастомозу сприяе зниженню частоти стриктур анастомозу та рефлюкс-езофапту, неспроможтсть анастомозу не спостерiгали.
Ключовi слова: мехатчний анастомоз, швагтацтний, циркулярний, недостаттсть анастомозу, стриктури, рефлюкс-езофагiт.
Стаття надтшла 30.07.18 р.
ПОСЛЕОПЕРАЦИОННЫЕ ОСЛОЖНЕНИЯ СО
СТОРОНЫ АНАСТОМОЗА У БОЛЬНЫХ СО ЗЛОКАЧЕСТВЕННЫМИ НОВООБРАЗОВАНИЯМИ ПИЩЕВОДА И КАРДИОЭЗОФАГЕАЛЬНОГО ПЕРЕХОДА
Усенко А.Ю., Сидюк А.В., Климас А. С., Сидюк Е.Е.
Формирование пищеводно-желудочных анастомозов после эзофагектомии, несмотря на явный прогресс, все еще сопровождается развитием у пациентов осложнений, связанных с анастомозом. Однако информация о влиянии способа формирования эзофагогастроанастомоза на последствия после эзофагектомии остается противоречивой. Цель работы - предоставить сравнительную характеристику послеоперационных осложнений у больных после резекции пищевода в зависимости от способа формирования механического эзофагогастроанастомоза. В исследование включены 30 пациентов, которым был сформирован разработанный и защищённый патентом Украины инвагинационный механический эзофагогастроанастомоз (группа исследования) и 30 больных, которым был сформирован циркулярный механический
эзофагогастроанастомоз конец-в-бок (группа сравнения) после эзофагэктомии. Оценивали частоту несостоятельности эзофагогастроанастомоза, частоту рубцовых стриктур, частоту и выраженность рефлюкс-эзофагит. В динамике всем больным проведена фиброэзофагогастро-дуоденоскопия, выраженность рефлюкс-эзофагита оценивали в соответствии с модифицированной Лос-Анджелесской классификацией. Статистический анализ данных проведен с использованием пакета статистического анализа EZR v. 1.35 (Saitama Medical Center, Jichi Medical University, Saitama, Japan), графический интерфейс к R (The R Foundation for Statistical Computing, Vienna, Austria). В условиях формирования инвагинационного механического эзофагогастроанастомоза результаты выявили
статистически значимое снижение количества стриктур анастомоза (p = 0,047) (17% (95% ВИ 5,4% - 32,6%), против 43% (95% ВИ 25,7% - 61, 9%), ОР = 0,4 (95% ВИ 0,2 - 0,9), а также частоту пост-резекционного рефлюкс-эзофагита (43% против 68%; p = 0,02) по сравнению с циркулярным механическим эзофагогастроанастомозом конец-в-бок. Однако между двумя группами не было выявлено существенных различий по несостоятельности анастомоза. Отметим, что в условиях формирования инвагинационного механического эзофагогастроанастомоза его
несостоятельности не было обнаружено (0% против 7%, p = 0,49). Способ формирования инвагинационного механического эзофагогастроанастомоза способствует снижению частоты рубцовых стриктур анастомоза и рефлюкс-эзофагита, несостоятельности анастомоза не наблюдали.
Ключевые слова: механический анастомоз, инвагинационный, циркулярный, недостаточность анастомоза, стриктуры, рефлюкс-эзофагит.
Рецензент Ляховський В.1.
