Nutritional Support for Patients Operated on for Malignant Tumors of the Hepatico-pancreato-duodenal (HPD) Zone in the Early Postoperative Period
Phase: NA
Conditions: Nutritional Support, Hepato-Biliary Neoplasm, Postoperative
Sponsor: Karaganda Medical University

KARAGANDA STATE MEDICAL UNIVERSITY 
Clinical trial protocol 
“Nutritional support for patients operated on with malignant tumors of the 
hepotopancreatoduodenal zone in the early postoperative period” 
Protocol code: MUK
Protocol date: 17 March 2017
_NutS-HPD-PO_2017 
Karaganda 2017 

Principal Investigator: Davanov Sh.K., PhD student KSMU 
Tel.: +7 701 5530298. 
e-mail: sherzad85@mail.ru. 
Scientific consultants: 
Ph.D., associate professor, Dmitry Vladimirovich Vasiliev 
Tel: +7014883294 
e-mail: dimavas176@mail.ru. 
Doctor of Medical Sciences, Professor Kani Zhumkenovich Musulmanbekov 
Foreign consultant: MD, PhD, professor Alexandra Dorota Tsialkovskaya-Rush (Poland) 
Name and address of the organization where the research is being conducted: Karaganda 
State Medical University, department of resuscitation, anesthesiology and emergency medicine. 
Karaganda, st. Gogol, 40 and KGP OOD st. Krivoguza 189. 
Name and address of the laboratory involved:  Research Center Laboratory of the Karaganda 
State Medical University, Karaganda, st. Gogol, 40

 
 
 
 
Brief Summary: A pressing concern involves the efficient and intensive treatment of 
complications arising from malignant tumors in the hepatopancreatoduodenal region. This matter 
is closely tied to rectifying energy deficits, addressing insufficient body weight, and restoring 
proper metabolic processes. This is particularly crucial post-surgery, as the process is hindered 
by significant hypercatabolism, heightened nutritional requirements, and the presence of 
intoxication syndrome. 
 Methods. An investigation was carried out on 91 individuals aged 18 years and older 
who were afflicted with malignant tumors situated in the hepatopancreatoduodenal area. These 
patients were categorized into three distinct groups, each receiving a different form of nutritional 
assistance. 
The assessment encompassed various aspects of the patients' nutritional well-being, 
including outcomes from the screening protocol, body mass index, basal metabolic rate, and 
critical laboratory measurements such as blood lymphocyte count, total protein level, total 
bilirubin concentration, as well as ALaT and ASaT levels. 
 
Keywords: nutritional status, nutritional deficiency, nutritional support, sips, oncology, 
nutrition, tumors of the hepatopancreatobiliary zone. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

I.  Purpose of the study and introduction. 
 
Purpose of the study.  Comparative analysis of the degree of influence of isolated enteral, 
isolated parenteral and mixed type of nutritional support on the nutritional status of cancer 
patients after operations performed in the hepatopancreatoduodenal zone in connection with 
malignant neoplasms in the early postoperative period. 
Research objectives: 
1. To conduct a comparative assessment of the dynamics of nutritional deficiency and nutritional 
status of patients operated on for malignant tumors of the hepatopancreatoduodenal zone in the 
early postoperative period during isolated enteral, isolated parenteral and mixed types of 
nutritional support. 
2. To analyze the dynamics of the state of protein and carbohydrate metabolism, the consistency 
of liver function in cancer patients operated on for malignant tumors of the 
hepatopancreatoduodenal zone, against the background of isolated enteral, isolated parenteral 
and mixed type of nutritional support in the early postoperative period. 
3. To determine the degree of effectiveness of these methods of nutritional support in this 
category of patients based on the totality of the results of assessing nutritional status and the 
dynamics of the level of basal metabolism in patients in the early postoperative period. 
 
Introduction. Treatment of malignant tumors of the hepatopancreatobiliary zone is one of the 
most pressing problems in clinical oncology. Among diseases of the liver and extrahepatic 
biliary tract, the most severe can be considered those that are accompanied by persistent 
obstruction of the main bile ducts with the subsequent development of obstructive jaundice (MJ), 
the treatment of which is still controversial. 
     Despite the increased availability of various highly sensitive non-invasive methods for 
diagnosing tumors of these organs, the detection of cancer of these organs in the early stages of 
the disease has practically not increased. In the vast majority of cases, patients continue to be 
admitted to specialized hospitals only with the development of various complications of cancer 
of the pancreatoduodenal zone, such as obstructive jaundice, duodenal obstruction, hepatic-renal 
failure, tumor invasion of hollow organs and bleeding into the lumen of the gastrointestinal tract 
(Patyutko Yu.I., Kotelnikov A.G., 2007). 
       43-87% of patients with malignant neoplasms of various localizations have pronounced 
disturbances in body composition, which correlate with the prevalence of the tumor process and 
are aggravated during combined treatment. This is based on disturbances in protein, 
carbohydrate and fat metabolism caused by the systemic effect of the tumor on the body.    
Violation of nutritional status has a significant impact on the outcome and prognosis of the 
disease, inevitably increases the duration and cost of treatment, contributes to an increase in 
mortality and the number of complications, such as infection, slower wound repair, 
immunosuppression, hemocoagulation disorders, decreased concentrations of blood plasma 
proteins and a number of enzymes, metabolic disorders medications, decreased tolerance to 
surgical treatment, radiation and chemotherapy. BUT. Stadley showed that when depleted 
patients lost 20% of their initial body weight, mortality after surgery reached 33%, and in non-
depleted patients -3.5%. According to B.R. Bistrian, G.L. Blakburn, with a 5% decrease in body 
weight during hospital stay, the length of stay increases by 2 times, and the frequency of 
complications increases by 3.3 times. J.L. Mullen and G.P. Buzby (1980) showed that impaired 
nutritional status in surgical patients leads to an increase in postoperative complications by 6 
times, and mortality by 11 times, while timely administration of adequate nutritional therapy to 
such depleted patients reduces the number of postoperative complications by 2-fold. 3 times, and 
lethality - 7 times. 

In this regard, the importance of accurately assessing the nutritional status of patients is obvious, 
which is the first step in treating and preventing further progression of malnutrition. A variety of 
methods are used to assess a patient's nutritional status. The use of enteral nutrition in the 
postoperative period contributes to the rapid elimination of intestinal paresis, early activation of 
intestinal motility, improved regeneration of the intestinal mucosa and activation of its 
absorption function. 
     The possibility of preventing excessive microbial contamination of the gastrointestinal tract, a 
preventive effect against acute erosive and ulcerative injuries, stopping the catabolic direction of 
metabolism, normalizing the immune status, reducing the number of infectious complications, 
reducing the time of stay of patients in the hospital were also noted [Bakhman A L, 2001, 
Shcherbakova GN, 1996, KostyuchenkoAL, 2001, GrämlichL, 2004, MertesN, 2000, KomplanL, 
1999]. There are difficulties in developing protocols and methods for assessing nutritional status 
and the effectiveness of enteral nutrition in the early postoperative period in patients with 
hepatopancreatobiliary diseases. 
   To solve the problems of perioperative nutritional support during extensive surgical 
interventions on the abdominal organs, aimed at eliminating metabolic disorders and fully 
meeting the energy-plastic needs of the body, as well as to eliminate preoperative nutritional 
deficiency, both parenteral and enteral nutrition are used [Levit D.A., 2008, Davidson, W., 2004, 
Olofsson B., 2007, Awad S., 2012]. 
 
II. Criteria for selecting study participants. 
1. Number of participants. (91 patients), will be divided into 3 groups  
1. The first group (n=31) included patients who received enteral nutrition (EN) after surgery.  
2. The second group (n=30) included patients receiving parenteral nutrition (PN). 
3. The third group (n=30) receiving mixed nutrition (MN), as is commonly considered the 
method of partial parenteral nutrition, in the early postoperative period. 
 
2. Gender distribution  
The study will include both genders. 
3. Age. 
Age from 20 to 75 years. 
4.Nationality (ethnicity). 
The racial and ethnic distribution of participants was not significant, so the study included 
individuals of varying national and ethnic backgrounds. 
5.Criteria for inclusion. 
- patients or relatives who consented to participate in the study (informed consent). 
- patients with concomitant diseases (cardiovascular disease, liver and kidney dysfunction, lung 
diseases) that may complicate the course of the operation and the postoperative period, or 
patients who have previously undergone various operations. 
6. Criteria for exclusion. 
-age up to 20 years, pregnant and lactating 
- patients with an unstable condition, unstable hemodynamics or severe concomitant pathology 
in the acute stage. 
7. Vulnerable groups. 
The study did not include participants who are considered to be in a vulnerable group. 
 
III. Methods and procedures 
Study plan: 
1) Content analysis of medical documentation. 
IV. 2) Obtaining informed consent; 

3) Biochemical studies: transaminases, thymol test, urea, creatinine, study of total protein 
and its fraction, state of nitrogen metabolism, blood glucose level, body mass index 
      4) Study of the acid-base state and gas composition of the blood. 
      5) Control of tests before and in the early postoperative period against the background of 
ongoing nutritional support (determining quantitative ratios of fat mass, water and dry matter in 
patients before surgery and in the early postoperative period). 
       6) Determination of the immunological state before and after surgery as part of nutritional 
nutrition.  
 
1. Methods and procedures. 
     At the first stage, modern ideas about methods for assessing nutritional status and methods of 
nutritional support in the early postoperative period of patients operated on for malignant tumors 
of the hepatopancreatoduodenal zone were studied.   
     At the second stage, taking into account the need to select the optimal method of nutritional 
support in the early postoperative period, patients underwent an intragroup and intergroup 
comparative analysis of the main clinical and laboratory indicators, reflecting the most 
satisfactory dynamics of plastic processes regarding the type of nutritional support: enteral, 
parenteral and mixed. 
     To solve these problems, a prospective, longitudinal, parallel study and retrospective analysis 
of the results of treatment of 91 patients with malignant tumors of the hepatopancreatoduodenal 
zone who underwent the following operations were carried out: 
1) resection of various segments of the liver; 
2) hemihepatectomy; 
3) transhepatic drainage of the right and left hepatic duct; 
4) bypass gastroenteroanastomosis or cholecystoenteroanastomosis with interintestinal 
enteroenteroanastomosis according to Brown; 
5) gastro-pancreatoduodenal resection; 
6) corporecaudal resection of the pancreas with splenectomy. 
     The study was carried out on the basis of the KGP at the RVC “Multidisciplinary Hospital 
No. 3 of the city of Karaganda”. Venue: intensive care unit. 
     To identify nutritional deficiencies, there are screening methods recommended by the 
international clinical nutrition associations ASPEN (American Society for Parenteral and Enteral 
Nutrition - ASPEN) and ESPEN (European Society for Parenteral and Enteral Nutrition - 
ESPEN), including questioning patients, using standard anthropometric and laboratory data, 
which makes it possible to assess nutritional status and the degree of its impairment. 
     At the first stage, the clinical condition of the patient was assessed using the Nutritional Risk 
Screening (NRS, 2002), Subjective Global Assessment (SGA) and Nutritional Risk Index (NRI) 
protocols before surgery and on the 5th, 10th, 15th day after surgery . 
     A comparative assessment of the clinical effectiveness of the use of types of nutritional 
nutrition 
in 
a 
complex 
of 
therapeutic 
measures 
after 
these 
operations 
in 
the 
hepatopancreatoduodenal zone was carried out. 
     Some nutritional status indicators available for determination at the Oncology Clinic were 
assessed - body mass index (weight measurements were carried out before surgery, on the 5th, 
10th and 15th days), basal metabolic rate (calculated using the Harris-Benedict equation, based 
on anthropometric data of the patient (gender, age, weight and height).), laboratory parameters: 
blood hemoglobin, lymphocytes, total protein, serum albumin, serum transferrin, total bilirubin 
and direct, ALT, AST, which are related to the traditional method for assessing nutritional status. 
     Additionally, we assessed the duration of postoperative gastrostasis, the timing of the onset of 
intestinal motility, the appearance of stool, the return to a normal diet, the length of patients' stay 
in the ICU, the readmission of patients to the ICU and the duration of the postoperative bed-day, 
and the incidence of complications was calculated. 
2. Data analysis and monitoring. 

Statistical processing of the obtained data will be carried out using the application package 
STATISTICA version 7.0, taking into account computational methods recommended for biology 
and medicine. Statistical research methods include: calculation of median and mode, standard 
deviation. To determine the reliability of the obtained indicators, Student's t-test will be used. 
Also calculate the pairwise correlation coefficient according to Pearson. 
3. Data storage and confidentiality. 
Confidentiality is ensured by encrypting the personal data of the subject with a digital code. 
Storage of information about patients is carried out in writing in the registration journal of the 
research topic, in electronic form on a computer in the databases of Microsoft Excel and 
STATISTICA 7.0 programs. The head and executor of the research topic have access to the data. 
The results of the research, without indicating personal data, will be used to write a doctoral 
dissertation, the results of the research will be published in print and electronic publications and 
reported at conferences. 
 
IV. Risk/benefit assessment 
1. Degree of risk. 
When conducting research, the degree of risk is minimal. Before the study, participants will be 
interviewed to explain the purpose and methods of the study. Minimal risk means that the 
likelihood and magnitude of harm or discomfort expected in the study is no greater than would 
normally be encountered in everyday life or while receiving routine physical or psychological 
tests. The study will be conducted in compliance with all requirements and safety measures. 
2. Potential risk. 
During the study, exacerbation of pre-existing, chronic diseases is possible. In this case, the 
patient is excluded from the study and all necessary support and correction measures are taken. 
3. Protection from risk. 
This procedure is introduced voluntarily and participants or other legal representatives of the 
patient have the right to refuse the examination. In order to exclude exacerbations of pre-existing 
chronic diseases, a thorough medical history will be taken and concomitant pathology taken into 
account. 
4. The potential benefit for the participant is the possibility of early nutritional support in cancer-
surgical patients, receiving timely recommendations on lifestyle management, prevention, 
treatment and rehabilitation. 
5. Alternatives for the participant. 
Participants have the right to refuse the proposed research method. In this case, treatment will be 
carried out using the traditional method. Without the written consent of the participant or legal 
representatives, the patient cannot be included in the study. 
V. Identification of Study Participants, Recruitment and Consent 
Before each study, patients are explained the goals and objectives of the study, informed of their 
right to refuse examination at any stage, and written consent to undergo treatment is obtained. 
1. Methods for identifying participants and recruiting them. 
The subjects will be selected by a continuous method during screening and patients with cancer 
pathology will be randomly selected.  
2. Consent process. 
The consent process will be carried out by the researcher in the form of written consent after 
explaining to the participants the purposes and methods of the study, as well as all potential 
risks, in accordance with the norms of the standard of Good Clinical Practice (GCP). 
3.Participant's condition. 
It is necessary to obtain informed consent from the patient in person. If it is not possible to obtain 
informed consent, the patient is not included in the study. 
4.Understanding. 
After the goals and objectives of the study have been explained and potential benefits and risks 
have been discussed with the participant, the participant will be asked to sign an informed 

consent form. The patient may refuse to participate in the study if he wishes. Children and 
incapacitated adults will not be included in the study. 
5.Consent forms. 
The informed consent form is presented in Appendix 1 to this protocol. 
6. Documentation of consent. 
Informed consent, in two copies, is voluntarily signed by the study participant and the research 
physician, and one copy remains with the research subject, the second is stored in the study file 
and the registration journal of the research topic. 
7. Participation price. 
There is no cost of participation for patients. 
8.Participation fee. 
There is no payment to the participant. 
 
 
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Informed consent form for participation in a clinical trial 
 
Head of the study: Kani Zhumkenovich Musulmanbekov 
    Responsible researcher: Davanov Sherzad Kurbanalievich 
    To solve the problems posed to the researcher it is necessary: a comparative assessment of 
various methods of parenteral (infusion) nutritional support.   The patient has the right to refuse 
the proposed studies. 
    The criteria for interrupting the participation of individual study participants is: the presence 
of concomitant somatic pathology, in case of patient refusal from the study. 
   The patient receives treatment in full according to the Medical and Economic Standard. 
    All information received is strictly confidential and is not subject to disclosure. 
    The patient can receive additional information about the progress of the study by calling:   
 
Written consent of the patient to conduct the above studies 
 
I,_________________________________________________, live at , 
tel. identification 
No., issued by the physician-researcher _____________________ 
About the nature of the planned clinical 
research__________________________________________ 
                                                                                                        
I received written and oral information about the goals, objectives, and nature of the upcoming 
clinical trial. 
        I had the opportunity to discuss with the researcher all the questions that interested me and 
get clarification on them. 
       I voluntarily agree to take part in a clinical study, I am informed that I have the right to 
refuse or at any time to stop participating in this study, without explaining the reasons for my 
decision. 
       I agree to follow the instructions, cooperate in good faith with the research doctor and 
immediately inform him of any kind of disturbance in my health or changes in my well-being. 
     I agree that the information obtained during the clinical trial will be used for scientific 
purposes. 
      I have been advised that if my health is harmed as a result of my participation in a clinical 
trial, I will be compensated by the investigator. The amount or terms of compensation may be 
revised if I am at fault for the deterioration in my health. 
    Received a signed and dated copy of the study participant's informed consent to participate in 
the clinical trial. 
On three (3) pages. 
 
Signature of study participant date 
 
I confirm that I have explained in detail the purpose and possible risks of the clinical trial to the 
participant 
research_______________________________________ 
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responsible researcher_________________________ 
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participant and the fact of signing the informed consent. 
 
FULL NAME. 

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Karaganda Medical University 
 
Report 
 
“Nutritional support for patients operated on with malignant tumors of the 
hepotopancreatoduodenal zone in the early postoperative period” 
 
 
Principal Investigator: Davanov Sh.K., PhD student KSMU 
Tel.: +7 701 5530298. 
e-mail: sherzad85@mail.ru. 
 
Scientific consultants:  
Ph.D., associate professor, Dmitry Vladimirovich Vasiliev 
Tel: +7014883294 
e-mail: dimavas176@mail.ru. 
Doctor of Medical Sciences, Professor Kani Zhumkenovich Musulmanbekov 
Foreign consultant: MD, PhD, professor Alexandra Dorota Tsialkovskaya-Rush (Poland) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Karaganda 2020 

Report 
№ MUK_NutS-HPD-PO_2017 from March 17, 2020 
Karaganda Medical University 
This study was approved by the Karaganda Medical University of the city of Karaganda of the Republic 
of Kazakhstan. Research and Ethics Committee of February 12, 2020 Protocol  №4. All methods were 
carried out in accordance with ethical principles and rules approved by the ethics committee. 
The clinical trial period was started in January 2017 and completed in March 2020 
Purpose of the study: To improve the nutritional status of cancer patients after operations performed in 
the hepatopancreotoduodenal zone in connection with malignant neoplasms, through a comprehensive 
comparative analysis of the effectiveness of isolated enteral, isolated parenteral and mixed type of 
nutritional support in the early postoperative period. 
Scientific hypothesis 
Complete and comprehensive nutritional support for patients operated on for malignant neoplasms of 
the hepatopancreatoduodenal zone, in the form of various approaches and methods of delivering 
nutrients to patients in the early postoperative period, allows to improve the functional activity of the 
gastrointestinal tract of patients, stabilize the level of carbohydrate, protein, basal metabolism, accelerate 
transfer to full enteral nutrition and reduce the length of stay in the intensive care unit and, ultimately, in 
the hospital. 
Research objectives: 
1. To conduct a comparative assessment of the dynamics of nutritional deficiency and nutritional status 
of patients operated on for malignant tumors of the hepatopancreatoduodenal zone in the early 
postoperative period during isolated enteral, isolated parenteral and mixed types of nutritional support. 
2. To analyze the dynamics of the state of protein and carbohydrate metabolism, the consistency of liver 
function in cancer patients operated on for malignant tumors of the hepatopancreatoduodenal zone, 
against the background of isolated enteral, isolated parenteral and mixed type of nutritional support in 
the early postoperative period. 
3. To determine the degree of effectiveness of these methods of nutritional support in this category of 
patients based on the totality of the results of assessing nutritional status and the dynamics of the level 
of basal metabolism in these patients in the early postoperative period. 
Researched 91 patients, will be divided into 3 groups:   
1. The first group (n=31) included patients who received enteral nutrition (EN) after surgery.  
2. The second group (n=30) included patients receiving parenteral nutrition (PN).  
3. The third group (n=30) receiving mixed nutrition (MN), as is commonly considered the method of 
partial parenteral nutrition, in the early postoperative period. 
Clinical research program: 
     The study was carried out on the basis of the KGP at the RVC “Multidisciplinary Hospital No. 3 of 
the city of Karaganda”. Venue: intensive care unit. 

   To identify nutritional deficiency, there are screening methods recommended by the international 
clinical nutrition associations ASPEN (American Society for Parenteral and Enteral Nutrition - ASPEN) 
and ESPEN (European Society for Parenteral and Enteral Nutrition - ESPEN), including questioning 
patients, using standard anthropometric and laboratory data, which makes it possible to assess 
nutritional status and the degree of its impairment. 
    At the first stage, the clinical condition of the patient was assessed using the Nutritional Risk 
Screening (NRS, 2002), Subjective Global Assessment (SGA) and Nutritional Risk Index (NRI) 
protocols before surgery and on the 5th, 10th, 15th day after surgery . 
A comparative assessment of the clinical effectiveness of the use of types of nutritional nutrition in a 
complex of therapeutic measures after these operations in the hepatopancreatoduodenal zone was carried 
out. 
     Some nutritional status indicators available for determination at the Oncology Clinic were assessed - 
body mass index (weight measurements were carried out before surgery, on the 5th, 10th and 15th 
days), basal metabolic rate (calculated using the Harris-Benedict equation, based on anthropometric data 
of the patient (gender, age, weight and height).), laboratory parameters: blood hemoglobin, 
lymphocytes, total protein, serum albumin, serum transferrin, total bilirubin and direct, ALT, AST, 
which are related to the traditional method for assessing nutritional status. 
Additionally, we assessed the duration of postoperative gastrostasis, the timing of the onset of intestinal 
motility, the appearance of stool, the return to a normal diet, the duration of patients' stay in the ICU, the 
repeated admission of patients to the ICU and the duration of the postoperative bed-day, and the 
incidence of complications was calculated. 
 
Methods of statistical data analysis 
      All patients hospitalized for special treatment with a verified diagnosis of a malignant neoplasm 
were subjected to the study in the abdominal department of the KGP at the Regional Oncological 
Dispensary, Karaganda. 
The quantitative and qualitative indicators obtained during the study were analyzed using descriptive 
and analytical statistics methods. For statistical processing of qualitative (diagnosis codes, dichotomous 
data) and quantitative variables: symptom intensity, severity, frequency of occurrence, we used the 
calculation of the median level (Me) with 25%-75% quartiles (Q25; Q75) and the calculation of the 
arithmetic mean (M) with error (m) and 95% confidence interval (95% CI), standard deviation (s). 
Quantitative variables were checked for normality of distribution using the Kolmogorov-Smirnov test, 
as well as the module of Skewness and Kurtosis for quantitative variables ǀ≤2ǀ. Differences in the 3 
groups of patients for quantitative variables corresponding to a normal distribution were identified using 
the Student's t test for unrelated groups, first for 3 or more groups, and then in pairs for each pair using 
the Student's t test. Differences for rank variables, or quantitative but not normally distributed for 
unrelated groups, were determined by the Kruskal-Wallis test or median test for 3 groups, and then 
pairwise or non-parametric Mann-Whitney test for each of the 3 pairs (groups 1 and 2, groups 1 and 3, 
groups 2 and 3), and for related groups (dynamic observations) by the Kendall test for 3 groups and then 
by the Wilcoxon test (Wilcoxon) for each of the 3 pairs (baseline, after 5 days and after 10 days). 

Correlation was performed for quantitative variables according to Pearson and for rank variables 
according to Spearman. Statistical processing of the results was carried out using the Statistica program 
version 10. 
Results and discussion. The nutritional status of patients in all three groups before surgery and during 
the 10-12 days of the postoperative period according to the methods of assessing nutritional status NRS, 
SGA and NRI was assessed as normal, moderate and severe malnutrition 
As can be seen from the presented data, in the preoperative period, according to the SGA assessment, 24 
patients in the enteral group, 19 patients in the parenteral group, and 17 patients in the mixed group had 
normal nutritional status before surgery, with variations relative to patients with moderate to severe 
malnutrition. Assessment of nutritional status before surgery using the NRI scale allowed us to confirm 
the nutritional status of the vast majority of patients in all groups as relatively normal 
      Thus, in 62 of the 91 patients examined, the NRI was assessed as true negative (normal nutritional 
status), in 26 as true positive (moderate malnutrition), and in 3 as severe malnutrition. Data from the 
NRI method during this time period had a strong correlation with the results of the SGA scale (p < 
0.005). 
      On the 10-12th day of the postoperative period in patients of the “enteral” group, the results of the 
assessment on the SGA scale remained unchanged; according to the NRI rating scale, there was an 
increase in “moderate malnutrition” per patient (25%). 
With parenteral nutritional support, 17 patients had “normal nutrition”, 14 patients had moderate 
malnutrition, with regression of “severe malnutrition” in 1 patient. In the mixed nutrition group, there 
was a complete elimination of signs of “severe malnutrition” by 100% according to the given scales (p 
<0.005). 
      In patients of all study groups, throughout the entire period of nutritional support, fluctuations in the 
level of basal metabolism were observed in average values of 335.89±53.6 kcal/day (13.44%) from the 
initial value - 1-2 days of the postoperative period and were due to variability body mass index and the 
dynamics of the temperature curve after surgery. 
      In patients in the groups with enteral and parenteral nutrition, by the end of these types of energy 
subsidies (days 10-15), the level of basal metabolism was observed to approach its initial values - 
2500.1±353.4 kcal/day and 2350.0±330.5 kcal/day days accordingly. With a mixed type of nutrition, 
there was a statistically significant decrease in the level of basal metabolism by 6.78% (2250.0±105.2 
kcal/s), which allows us to conclude that patients’ energy costs are more effectively covered with this 
option of nutritional support in a comparative aspect with isolated types nutrition (p<0.03). 
This fact was obviously associated with the preservation/restoration of parietal digestion in the 
gastrointestinal tract in the early postoperative period, despite postoperative intestinal paresis of varying 
degrees, and the involvement of nutrients in anabolic processes with parallel “covering” of the required 
daily caloric intake by parenteral administration of mixtures. 
      Evaluation and subsequent analysis of the results of laboratory examination in groups of patients in a 
comparative aspect showed a relatively slow and gradual decrease in the level of total blood protein by 
the 5th day of the postoperative period, on average, by 6.8±0.95% of the initial values, which, 

apparently , was due to increased catabolism and ongoing protein losses (exudation, drainage, etc.) with 
a fairly significant increase by the end of nutritional support. 
      Thus, a statistically significant increase in the level of total blood protein was noted in the mixed 
nutrition group (p = 0.004). In the groups with enteral and parenteral nutrition, differences in the 
dynamics of total protein levels were found at the level of a statistical trend: p=0.108 and p=0.129, 
respectively. 
       When analyzing changes in the number of blood lymphocytes, it should be noted that before the 
operation the relative value of lymphocytes in the groups was significantly reduced (25.9±3.7%), but 
taking into account the methods and volumes of the operation, the tension of the cellular and humoral 
parts of the immune system, the dynamics of their level was expressed in the form of a statistically 
significant increase in the level of lymphocytes in the postoperative period by 10-12 days. 
      Thus, there was a steady increase in the level of blood lymphocytes by the 10th day of the 
postoperative period in all groups, on average by 8.95% (p = 0.000), by 10.35% (p = 0.003), by 10.91% 
(p = 0.000) respectively. 
      This dynamics reflects the positive effect on the immune status of patients of the combined use of 
parenteral and enteral types of nutritional support in the postoperative period in this group of patients. 
      A comparative analysis of the dynamics of ALT and ASAT values in all patients in the study groups 
on the 2-3, 6-8, 10-12 days of the postoperative period reflected an excess of their normal values after 
surgery in some patients tens of times in the first day of the postoperative period. These changes can be 
explained, first of all, by the surgical intervention itself and its volume, the underlying disease of the 
hepatopancreatoduodenal zone and the associated cytolytic syndrome against the background of 
cholestasis [9,10,11]. 
      In terms of assessing the dynamics of blood transaminase levels, in the majority of patients in the 
first group (78.2%), by the 5th and 10th days there was a decrease in ALT and AST values, on average, 
by 32.1 and 40.15%, respectively. 
      In the overwhelming number of patients in the second group (81.6%, n=26), a statistically 
significant decrease in the level of these blood transaminases was also recorded, on average by 72.2% 
by the fifth day and 66.7% by the 10th day of the postoperative period from level of their initial 
indicator. 
      With a mixed type of nutritional support, by the 5th day of the postoperative period, the average 
significant decrease in transaminases was, on average, up to 72.6% of the initial values (p = 0.000); by 
the 10th day of the postoperative period, their level decreased to 63.8% from the previous achieved 
value of 5 days (p=0.008). 
      When comparing analyzes of the level of total blood bilirubin in patients of all nutrition groups, 
there was a strong direct correlation with a decrease in the level of blood transaminases, which, 
apparently, was also due to the creation of sufficient intraoperative bile outflow due to drainage of the 
biliary tract and elimination of the cause of obstructive jaundice (tumor). 

However, high values of total blood bilirubin that persisted on the first day after surgery were due to 
temporary swelling of the biliary tract, which caused the excess of the norm by more than 10 times (p = 
0.000). 
      On days 5-7, there was a tendency towards a 5-6 fold decrease in its level from the initial values, 
which gradually decreased to normal values by days 10-12 and in some patients persisted until discharge 
from the hospital (p = 0.004). 
      In comparative quantitative terms, in patients of the first group, a decrease in the level of total 
bilirubin was recorded, on average, by 12.7% only by the 10th day after surgery (p = 0.187). In the 
second group, there was a decrease in the level of total blood bilirubin by the 5th day, on average, by 
40.09% and by the 10th day by 45.0% from its initial values (preoperative period), (p = 0.002). 
      In patients of group 3, there was a slower regression of this indicator: a decrease, on average, by 
20.0% by the 5th day and by 44.0% by the 10th day of the postoperative period [1,5,12]. 
     
Conclusion: 
1. According to the NRI nutritional status assessment scales, the SGA mixed type of nutritional support 
at the time of transfer of patients to the specialized department and upon completion of this area of 
intensive therapy in the specialized department by 12-15 days of the postoperative period showed higher 
effectiveness in stabilizing the condition and maintaining the patients’ caloric intake in a comparative 
aspect with the group of isolated enteral nutrition and parenteral nutrition. 
  2. Throughout the entire period of isolated enteral, parenteral and mixed nutritional support, all patients 
(100%) showed a relatively constant level of total blood protein. 
  3. In patients of all three groups, throughout the entire period of nutritional support, fluctuations in the 
level of basal metabolism were observed, which was due to the variability of body mass index and the 
dynamics of the temperature curve after surgery. In patients in the groups with enteral and parenteral 
nutrition, by the end of nutritional support (days 15-20), the level of basal metabolism was observed to 
approach its initial values. With a mixed type of nutrition, a statistically significant decrease in the level 
of basal metabolic rate was observed, which suggests a more effective coverage of the energy costs of 
patients with this option of replenishing nutritional ingredients.