Nutritional Support for Patients Operated for Malignant Tumors in HPD Zone

Not Applicable

Completed

• Conditions: Postoperative; Hepato-Biliary Neoplasm; Nutritional Support
• Interventions: Dietary Supplement: parenteral nutrition supplements; Dietary Supplement: enteral nutrition supplements; Dietary Supplement: mixed nutrition supplements

• Registration Number: NCT06397430
• Lead Sponsor: Karaganda Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2017-12-01
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2024-04
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Study First Posted: 2024-05-02
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 - parenteral nutrition	parenteral nutrition supplements	patients receiving parenteral nutrition (PN)
Arm 1 - enteral nutrition	enteral nutrition supplements	patients receiving enteral nutrition (EN) after surgery
Arm 3 - mixed nutrition	mixed nutrition supplements	patients receiving mixed nutrition (MF)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Karaganda Medical University; 🇰🇿 Karaganda, Kazakhstan