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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06397430
Enrollment
91
Registered
2024-05-02
Start date
2017-12-01
Completion date
2020-02-28
Last updated
2024-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepato-Biliary Neoplasm, Nutritional Support, Postoperative

Keywords

nutritional support, Hepato-Biliary Neoplasm, postoperative curation

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

Interventions

DIETARY_SUPPLEMENTparenteral nutrition supplements

parenteral nutrition

DIETARY_SUPPLEMENTenteral nutrition supplements

enteral nutrition

DIETARY_SUPPLEMENTmixed nutrition supplements

mixed nutrition

Sponsors

Karaganda Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

prospective, longitudinal, parallel study

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with changes of BMI in kg/m^2Day 0, Day 5, Day 10, Day15Variables of Body mass index measured by Canadian Guidelines for Body Weight Classification in Adults
Basal Metabolic rateDay 0, Day 5, Day 10, Day15basal metabolic rate according to the Harris-Benedict equation
Total protein level in BloodDay 0, Day 5, Day 10, Day15Blood biochemical analysis: total protein in g/L
Serum albumin in g/LDay 0, Day 5, Day 10, Day15Blood biochemical analysis: serum albumin in g/L
Serum transferrin in g/LDay 0, Day 5, Day 10, Day15Blood biochemical analysis: serum transferrin in g/L
Total bilirubin in mmol/LDay 0, Day 5, Day 10, Day15Blood biochemical analysis: total bilirubin in mmol/L
Direct bilirubin in mmol/LDay 0, Day 5, Day 10, Day15Blood biochemical analysis: direct bilirubin in mmol/L
ALT in IU/LDay 0, Day 5, Day 10, Day15Blood biochemical analysis: ALT in IU/L
AST in IU/LDay 0, Day 5, Day 10, Day15Blood biochemical analysis: AST in IU/L

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026