Nutritional Support for Patients Operated for Malignant Tumors in HPD Zone

Nutritional Support for Patients Operated on for Malignant Tumors of the Hepatico-pancreato-duodenal (HPD) Zone in the Early Postoperative Period

A comprehensive comparative analysis of the effectiveness of isolated enteral, isolated parenteral and mixed type of nutritional support in the early postoperative period in patients after operations performed on the malignant neoplasms of hepatico-pancreatico-duodenal zone.

Study Overview

• Status: Completed
• Conditions: Postoperative; Nutritional Support; Hepato-Biliary Neoplasm
• Intervention / Treatment: Dietary supplement: enteral nutrition supplements; Dietary supplement: parenteral nutrition supplements; Dietary supplement: mixed nutrition supplements

Detailed Description

A prospective, longitudinal, parallel study and retrospective analysis of the results of treatment of 91 patients with malignant tumors of the hepatico-pancreato-duodenal zone who underwent the following operations:

1. resection of various segments of the liver;
2. hemihepatectomy;
3. transhepatic drainage of the right and left hepatic duct;
4. bypass gastroenteroanastomosis or cholecystenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
5. gastro-pancreato-duodenal resection;
6. corpore-caudal resection of the pancreas with splenectomy.

The first group (n=31) included patients who received enteral nutrition (EN) after surgery. The second group (n=30) included patients who received parenteral nutrition (PN) and the third group (n=30) who received mixed nutrition (MN), as a variation of the partial parenteral nutrition technique, in the early postoperative period.

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, alanine aminotransferase (ALT), aspartate aminotransferase (AST), which are related to the traditional method for assessing nutritional status

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kazakhstan
  • Karaganda, Kazakhstan, 100008
    • Karaganda Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

female and male patients in age of 20-75 with malignant tumors of the hepato-pancreato-duodenal zone who have undergone any of the following operations:

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.

Exclusion Criteria:

• patients in age of up to 20 and older than 75
• pregnant and breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - enteral nutrition; patients receiving enteral nutrition (EN) after surgery	Dietary supplement: enteral nutrition supplements; enteral nutrition; Other Names: enteral nutrition
Experimental: Arm 2 - parenteral nutrition; patients receiving parenteral nutrition (PN)	Dietary supplement: parenteral nutrition supplements; parenteral nutrition; Other Names: parenteral nutrition
Experimental: Arm 3 - mixed nutrition; patients receiving mixed nutrition (MF)	Dietary supplement: mixed nutrition supplements; mixed nutrition; Other Names: mixed nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with changes of BMI in kg/m^2	Variables of Body mass index measured by Canadian Guidelines for Body Weight Classification in Adults	Day 0, Day 5, Day 10, Day15
Basal Metabolic rate	basal metabolic rate according to the Harris-Benedict equation	Day 0, Day 5, Day 10, Day15
Total protein level in Blood	Blood biochemical analysis: total protein in g/L	Day 0, Day 5, Day 10, Day15
Serum albumin in g/L	Blood biochemical analysis: serum albumin in g/L	Day 0, Day 5, Day 10, Day15
Serum transferrin in g/L	Blood biochemical analysis: serum transferrin in g/L	Day 0, Day 5, Day 10, Day15
Total bilirubin in mmol/L	Blood biochemical analysis: total bilirubin in mmol/L	Day 0, Day 5, Day 10, Day15
Direct bilirubin in mmol/L	Blood biochemical analysis: direct bilirubin in mmol/L	Day 0, Day 5, Day 10, Day15
ALT in IU/L	Blood biochemical analysis: ALT in IU/L	Day 0, Day 5, Day 10, Day15
AST in IU/L	Blood biochemical analysis: AST in IU/L	Day 0, Day 5, Day 10, Day15

Collaborators and Investigators

• Sponsor: Karaganda Medical University
• Investigators: Principal Investigator: Sherzad Davanov, MD, Karaganda Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Estimated): May 2, 2024

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: nutritional support; Hepato-Biliary Neoplasm; postoperative curation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: MUK_NutS-HPD-PO_2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No