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NCT Number: NCT06397430

Nutritional Support for Patients Operated for Malignant Tumors in HPD Zone

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.

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Key information

Conditions

Nutritional Support Hepato-Biliary Neoplasm Postoperative

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karaganda Medical University

Karaganda, 100008, Kazakhstan

About this study

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:

  • resection of various segments of the liver;
  • hemihepatectomy;
  • transhepatic drainage of the right and left hepatic duct;
  • bypass gastroenteroanastomosis or cholecystenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
  • gastro-pancreato-duodenal resection;
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • resection of various segments of the liver;
  • hemihepatectomy;
  • transhepatic drainage of the right and left hepatic duct;
  • bypass gastroenteroanastomosis or cholecystoenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;
  • gastro-pancreatoduodenal resection;
  • corporecaudal resection of the pancreas with splenectomy.

Exclusion criteria

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

Treatment and study plan

parenteral nutrition supplements

Dietary Supplement

parenteral nutrition

Other names: parenteral nutrition

enteral nutrition supplements

Dietary Supplement

enteral nutrition

Other names: enteral nutrition

mixed nutrition supplements

Dietary Supplement

mixed nutrition

Other names: mixed nutrition

Primary outcomes

  1. Number of Participants with changes of BMI in kg/m^2

    Time frame: Day 0, Day 5, Day 10, Day15

    Variables of Body mass index measured by Canadian Guidelines for Body Weight Classification in Adults

  2. Basal Metabolic rate

    Time frame: Day 0, Day 5, Day 10, Day15

    basal metabolic rate according to the Harris-Benedict equation

  3. Total protein level in Blood

    Time frame: Day 0, Day 5, Day 10, Day15

    Blood biochemical analysis: total protein in g/L

  4. Serum albumin in g/L

    Time frame: Day 0, Day 5, Day 10, Day15

    Blood biochemical analysis: serum albumin in g/L

  5. Serum transferrin in g/L

    Time frame: Day 0, Day 5, Day 10, Day15

    Blood biochemical analysis: serum transferrin in g/L

  6. Total bilirubin in mmol/L

    Time frame: Day 0, Day 5, Day 10, Day15

    Blood biochemical analysis: total bilirubin in mmol/L

  7. Direct bilirubin in mmol/L

    Time frame: Day 0, Day 5, Day 10, Day15

    Blood biochemical analysis: direct bilirubin in mmol/L

  8. ALT in IU/L

    Time frame: Day 0, Day 5, Day 10, Day15

    Blood biochemical analysis: ALT in IU/L

  9. AST in IU/L

    Time frame: Day 0, Day 5, Day 10, Day15

    Blood biochemical analysis: AST in IU/L

Sponsors and collaborators

Lead sponsor

Karaganda Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 2, 2024
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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