CClinicalTrials.gg
CompletedNCT06397430Updated May 2, 2024

Nutritional Support for Patients Operated for Malignant Tumors in HPD Zone

An interventional study of parenteral nutrition supplements and enteral nutrition supplements in Nutritional Support, Hepato-Biliary Neoplasm and Postoperative, sponsored by Karaganda Medical University. Completed at 1 site in Kazakhstan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Karaganda Medical University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 years 4 months after the study started (first participant enrolled Dec 2017, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Non-randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Nutritional Support
  • Hepato-Biliary Neoplasm
  • Postoperative

Keywords

  • nutritional support
  • Hepato-Biliary Neoplasm
  • postoperative curation
03

In context

Biliary Tract Neoplasms

484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.

This study's enrollment of 91 is above the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.

Browse Biliary Tract Neoplasms studies →

Lead sponsor

Karaganda Medical University is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • patients in age of up to 20 and older than 75
  • pregnant and breastfeeding women
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • Experimental
    Arm 1 - enteral nutrition

    patients receiving enteral nutrition (EN) after surgery

    Dietary Supplement: enteral nutrition supplements

  • Experimental
    Arm 2 - parenteral nutrition

    patients receiving parenteral nutrition (PN)

    Dietary Supplement: parenteral nutrition supplements

  • Experimental
    Arm 3 - mixed nutrition

    patients receiving mixed nutrition (MF)

    Dietary Supplement: mixed nutrition supplements

Interventions

  • Dietary supplementparenteral nutrition supplements

    parenteral nutrition

    Also known as: parenteral nutrition

  • Dietary supplemententeral nutrition supplements

    enteral nutrition

    Also known as: enteral nutrition

  • Dietary supplementmixed nutrition supplements

    mixed nutrition

    Also known as: mixed nutrition

06

What researchers measure

Primary outcomes

  1. 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

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

  2. Basal Metabolic rate

    basal metabolic rate according to the Harris-Benedict equation

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

  3. Total protein level in Blood

    Blood biochemical analysis: total protein in g/L

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

  4. Serum albumin in g/L

    Blood biochemical analysis: serum albumin in g/L

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

  5. Serum transferrin in g/L

    Blood biochemical analysis: serum transferrin in g/L

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

  6. Total bilirubin in mmol/L

    Blood biochemical analysis: total bilirubin in mmol/L

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

  7. Direct bilirubin in mmol/L

    Blood biochemical analysis: direct bilirubin in mmol/L

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

  8. ALT in IU/L

    Blood biochemical analysis: ALT in IU/L

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

  9. AST in IU/L

    Blood biochemical analysis: AST in IU/L

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

07

Study locations

1 site
  • Karaganda Medical University
    Karaganda, 100008, Kazakhstan
08

References and documents

Study documents

  • Protocol, analysis plan and consent form · Mar 17, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06397430
Lead sponsor
Karaganda Medical University
Responsible party
Sponsor
First posted
May 2, 2024
Start date
Dec 1, 2017
Primary completion
Feb 28, 2020
Completion
Feb 28, 2020
Last update
May 2, 2024

Study contacts

Sherzad Davanov, MD
principal investigator · Karaganda Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion