RU2718290C1 - Method of determining operability of patients suffering oesophageal cancer - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention refers to medicine, particularly to surgery, oncology, therapy, functional diagnostics, and can be used in determining the possibility of performing radical surgical treatment of patients suffering oesophageal cancer. Predictors are detected: presence of disturbed cardiac rhythm and conductance, chronic obstructive pulmonary diseases, pulmonary hypertension in echocardiography by mean-square pressure in pulmonary artery in mm Hg, left ventricle ejection fraction by Simpson in %, acute cerebrovascular accident in past history. Further, the predictors are scored. Probability of postoperative complications (K, %) is determined by the declared formula. If K is less than 12 %, the indications for the surgical intervention are determined. If K is from 12 to 75 %, the need for preoperative correction of the indices is determined. If K is more than 75 %, absence of indications for surgical intervention is stated.EFFECT: method provides high accuracy of prediction of complications, enables objectifying boundaries of physiological feasibility of surgical exposure to oesophageal tumour by evaluating complex of most significant predictors.1 cl, 1 tbl, 3 ex

Description

The invention relates to medicine, in particular to surgery, oncology, therapy, functional diagnostics and can be used to determine the possibility of performing radical surgical treatment of patients with esophageal cancer.

A known method for predicting cardiopulmonary complications in patients undergoing transpleural resection of the esophagus for cancer (S. S. Tkachenko. Possibilities for predicting, preventing and eliminating cardiopulmonary complications in transpleural resection of the esophagus in patients with esophageal cancer. Thesis for the degree of candidate of medical sciences. - 2010 g.). A quantitative assessment of 11 preoperative criteria for predicting cardiopulmonary complications of transpleural resection of the esophagus made it possible to identify the prognosis index of cardiopulmonary complications after a surgical manual.

Among the criteria for predicting cardiopulmonary complications in this method, indicators with a random nature of measurements were used: heart rate, estimated as bradycardia, normal heart rate and tachycardia; blood pressure divided into hypotension, normotonia and hypertension. These strata of known predictors can depend and vary on many factors, quickly change over a short period of time, have random values depending on the method and time of measurement, which casts doubt on their prognostic significance.

Another drawback of the method is the use of predominantly non-modifiable risk factors, which to a greater extent reflect demographic (gender, age) and anamnestic data (nature of work, presence of disability, history of alcoholism). The inclusion of a chronic obstructive pulmonary disease risk factor (COPD) in the model provides only anamnestic data on the presence of the disease without assessing the severity and characteristics of the obstructive process at the time of esophageal resection.

The absence of objectively measured functional indicators of the cardiovascular and respiratory systems in the list of main risk predictors also reduces the objectivity of the risk assessment of cardiopulmonary complications, making the prognosis less reliable and more stochastic. An important disadvantage of this method is that when the forecast index value is from -14 to +14 conventional units, the forecast for the development of complications remains uncertain, which makes the technique unsuitable for a significant part of the evaluated cases.

Closest to the claimed is a way to increase the safety of surgical treatment of patients with severe concomitant diseases with extracardiac surgery [Pat. RF №2410017]. The method is based on assessing the risk of developing perioperative cardiovascular complications (MTR) by calculating the individual risk index (IIR), which is produced by the regression equation, having the formula: IIR = 1 / (1 + EXP (3.858 - 0.399 ° C - 0.83) ⋅ХСН - 2.031⋅ФК2 - 2,212⋅ФК3-0,309⋅НР - 1,062⋅С5ЖЭ) where: IIR - individual risk index ССО; С70 - patient's age ≥ 70 years; CHF - presence of signs of chronic heart failure; II FC - presence of angina pectoris 2 -th functional class; III FC - the presence of angina of the 3rd functional class; HP - non-sinus rhythm of the heart; C 5ZHE - frequent (> 5 in min) ventricular extrasystole with sinus

The disadvantages of the method selected as a prototype are as follows:

1. The method does not include accounting for the development of complications from the respiratory system (pneumonia, endobronchitis, bronchospasm, etc.), which are extremely relevant for patients who underwent resection of the esophagus, and are the most common somatic complications of the postoperative period.

2. The use of a number of subjective parameters: the presence of angina II or III functional classes (FC). It is often impossible to objectively determine the difference between FC II and FC III of angina pectoris in patients with esophageal cancer with a reduced functional status. The functional component of the factor is also insufficiently disclosed, heart failure, which with III FC is a contraindication for planned high-risk surgical benefits, which include resection of the esophagus.

3. The method does not take into account the effect on the result of functional echocardiographic indicators that are able to predict somatic complications with proven accuracy.

4. The calculation of the risk of individual MTRs does not allow us to solve the main applied problem - to determine the operability of a particular patient by the set of his preoperative characteristics of comorbidity and functional status.

The objective of the present invention is to improve the accuracy of determining the operability of patients with malignant neoplasms of the esophagus.

The technical result of the task is achieved by the fact that in the method for determining the operability of patients with cancer of the esophagus, which consists in assessing the presence of cardiac arrhythmias and conduction disorders, as well as chronic obstructive pulmonary diseases, the presence of pulmonary hypertension, ejection fraction of the left ventricle, and acute cerebrovascular accident history and stages of chronic obstructive pulmonary diseases and determine the likelihood of developing somatic postoperative complications according to the formula:

Where:

K - the probability of developing postoperative complications in percent

EXP - exhibitor

LH - pulmonary hypertension

PV - left ventricular ejection fraction

ARITM - heart rhythm and conduction disorders

ONMK - an acute history of cerebrovascular accident

COPD - chronic obstructive pulmonary disease

With a value of K less than 12%, indications for surgical intervention are determined, with a value of K from 12 to 75%, the need for preoperative correction of indicators is determined, and with a value of K more than 75%, the absence of indications for surgical intervention is determined.

The factor of pulmonary hypertension (LH) is prognostically important for evaluating the operability of patients with esophageal cancer, since in the postoperative period the presence of hypertension in a small circle can contribute to pulmonary embolism (pulmonary embolism), and the aggravation of pulmonary hypertension can lead to the development of heart failure. During surgery and in the postoperative period against the background of LH, obstruction of small pulmonary vessels and, accordingly, damage to their endothelium can occur. This leads to activation of coagulation mechanisms, resulting in blockage of small vessels, which exacerbates pulmonary hypertension, further provoking the development of pulmonary embolism. Also, the estimated complications may be associated with the possible formation of blood clots due to short-term immobilization of the patient in the postoperative period, as well as direct trauma to the mediastinal organs during surgery.

Evaluation of the ejection fraction of the left ventricle (LVEF) is important, as it reflects the resource and reliability of blood circulation in a large circle. A decrease in LVEF suggests that the heart is not able to adequately provide blood to the organs of the large circle, which in the postoperative period, taking into account possible postoperative blood loss, can lead to hypoxia of the myocardium, kidneys, and brain. Low LVEF also increases the risk of developing arrhythmias and acute heart failure in the postoperative period.

Heart rhythm and conduction disturbances (ARITM) can lead to the development of target organ ischemia in the postoperative period, which is associated with the development of atrial fibrillation against the background of existing structural remodeling and electrical dissociation of muscle bundles. In this case, hemodynamic deficiency leads to the formation of blood clots, which can cause fatal embolic complications. A number of rhythm and conduction disturbances can increase the risk of developing pulmonary embolism, circulatory failure, sudden cardiac arrest, arrhythmogenic shock, are associated with the possible formation of a blood clot in the chambers of the heart, atrial and ventricular fibrillation.

A history of acute cerebrovascular accident (stroke) is a reflection of the existing risk factors for the development of CVD in the postoperative period, since it indicates the presence of multifocal atherosclerosis and is a reflection of the very high risk of heart failure, stage III hypertension with high degrees of arterial hypertension, and the presence of various forms of coronary heart disease. In the postoperative period, a repeated stroke may develop against the background of the already existing consequences of the transferred stroke.

Chronic obstructive pulmonary disease (COPD) is a recognized risk factor for the development of pulmonary complications after resection of the esophagus, since in the course of surgery there is an inevitable trauma to the pulmonary parenchyma and mediastinum. In the postoperative period, COPD is aggravated by circulatory disorders in the lung tissue and hypoventilation, which can lead to endobronchitis, recurrent pneumonia, and respiratory failure.

The intervals of the calculated indicator K determine the operability of patients with cancer of the esophagus. The indicator K from 1 to 12% indicates the normal functioning of the main organs and systems of the body, which indicates the absolute operability of the patient. The indicator K in the range from 12 to 75% suggests that there are changes in the body that, without correction, can lead to the development of complications in the postoperative period, i.e. the patient is conditionally operable. The K index of more than 75% indicates the presence of irreversible changes in the body, which will lead to complications in the postoperative period, which indicates the patient’s inoperability.

Thus, the prognostic value of this set of predictors lies in their unique combination and comprehensive complementarity. Moreover, the optimal combination of factors eliminates the duplication of risk factors for somatic complications and takes into account the main characteristics of both the comorbidity of a patient with esophageal cancer and the functional status of his cardiorespiratory system. All this leads to increased accuracy in assessing the operability of patients with malignant neoplasms of the esophagus.

The method is as follows. A patient with verified cancer of the esophagus is examined, including collecting and studying the anamnesis (the number of previously transferred stroke, the presence and severity of COPD, chronic bronchitis, emphysema is examined); a comprehensive physical examination is carried out, including the search for signs of COPD, respiratory failure, arrhythmic syndrome, echocardiography is carried out with the mandatory registration of SRDLA and EF according to Simpson; 24-hour ECG monitoring; spirometry is performed to assess the severity of respiratory disorders.

The resulting clinical information is used to gradate five predictors of risk for somatic complications:

1. The presence of pulmonary hypertension (LH), determined by echocardiography according to the average pressure in the pulmonary artery in mm RT. Art. (Srrdla; RAMP). LH factor codes: 0 - no LH or borderline LH (SrRLA ≤ 20 mmHg); 1 - moderate or significant (SRRDLA> 20 mm Hg).

2. The ejection fraction (EF) of the left ventricle according to Simpson in%. PV factor codes: 0 - normal (PV ≥ 55%); 1 - reduced (PV <55%).

3. Violations of the heart rhythm and conduction (Arrhythmia), detected during daily monitoring of the ECG. Codes of the arrhythmia factor are presented in the table (Appendix) 1.

4. An acute history of cerebrovascular accident (stroke). Gradations of the factor were established by the number of cases of stroke in the history of patient's life: 0, 1, 2, 3.

5. Chronic obstructive pulmonary disease (COPD) in the presence of a clinical picture of chronic bronchitis, bronchial asthma, emphysema is stratified according to the Spirometric (functional) classification of COPD according to the GOLD scale, 2011. Gradations of COPD factor: 1 - easy stage with FEV1 / VFJ <0 , 7 (70%) and FEV1 ≥ 80% of the due; 2 - moderate stage with FEV1 / FVC ≤ 0.7 (70%) and 50% ≤ FEV1 <80%.

After this, the values of five factors are placed in the formula and the indicator K is calculated (the probability of developing postoperative complications).

With a value of K less than 12%, indications for surgical intervention are determined, with a value of K from 12 to 75%, the need for preoperative correction of indicators is determined, and with a value of K more than 75%, the absence of indications for surgical intervention is determined.

Example 1. Patient A., 77 l. He was admitted with a diagnosis of squamous cell carcinoma of the middle and lower thoracic esophagus. The definition of patient operability by the claimed method. K = 83%. The patient was found inoperable and sent for palliative care at the place of residence.

Example 2. Patient Z., 61, was admitted with a diagnosis of squamous cell carcinoma of the lower third of the thoracic esophagus. The definition of patient operability by the claimed method. K = 56%. The patient was recognized conditionally operable, aimed at additional examination and medical correction of identified concomitant diseases. After 10 days, a scheduled operation was performed. The patient was monitored in intensive care for 3 days. On the 4th day he was transferred to the department, was discharged on the 10th day in a satisfactory condition.

Example 3. Patient G., 59 l. He was admitted with a diagnosis of adenocarcinoma of the abdominal esophagus. The definition of patient operability by the claimed method. K = 8.5%. The patient is recognized as operable. After 2 days, a scheduled operation was performed. The patient was monitored in intensive care for 3 days. On the 4th day he was transferred to the department, was discharged on the 10th day in a satisfactory condition.

The inventive method is available to clinicians, a simple non-invasive mechanism for solving a fundamental issue for a patient with esophageal cancer: an objective choice of the most effective and acceptable treatment method from the standpoint of predicting individual risk for a particular patient. A small set of five predictors ensures high accuracy in predicting complications, and makes it possible to objectify the boundaries of the physiological admissibility of the use of surgical exposure to a tumor in the esophagus.

Implementation of the proposed method will not only give a quantitative forecast of somatic complications, but also reduce the frequency of complications after traumatic resection of the esophagus by objectivizing the selection of patients for resection.

The method can eliminate the subjectivity inherent in assessing the operability of patients with esophageal carcinoma and improve the immediate results of large-scale high-risk operations - resection of the esophagus and esophagectomy. Based on the widely available available functional diagnostics methods, the method does not require the implementation of expensive laboratory, high-cost and complex instrumental studies.

Application:

Claims (10)

A method for determining the operability of patients with cancer of the esophagus, which consists in identifying predictors: the presence of cardiac arrhythmias and conduction disorders (ARITM), chronic obstructive pulmonary diseases (COPD), characterized in that they additionally detect the presence of pulmonary hypertension (PH) with echocardiography based on mean pressure in pulmonary artery in mm RT. Art., the ejection fraction of the left ventricle (EF) according to Simpson in%, acute history of cerebrovascular accident (ONMK), then predict predictors in points: ARITM in accordance with the table presented in the description; COPD: 1 - easy stage with FEV1 / FVC less than 0.7 (70%) and FEV1 equal to or more than 80% of the due; 2 - moderate stage with FEV1 / FVC equal to or less than 0.7 (70%) and FEV1 from equal to or more than 50% to less than 80%; LH: 0 - no LH or borderline LH with SrRLA less than or equal to 20 mm Hg; 1 - moderate or significant with SRRDLA more than 20 mm RT. st .; PV: 0 - normal with PV more than or equal to 55%; 1 - reduced with PV less than 55%; ONMK by the number of cases recorded, then determine the likelihood of postoperative complications (K,%) by the formula:

where K is the probability of developing postoperative complications in percent; EXP - exhibitor; LH - pulmonary hypertension; PV - left ventricular ejection fraction; ARITM - heart rhythm and conduction disorders; ONMK - an acute history of cerebrovascular accident; COPD - chronic obstructive pulmonary disease, and with a value of K less than 12% determine the indications for surgical intervention, with a value of K from 12 to 75% determine the need for preoperative correction of indicators, and with a value of K more than 75% determine the absence of indications for surgical intervention.