NCT06397430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

April 11, 2024

Last Update Submit

April 29, 2024

Conditions

Nutritional SupportHepato-Biliary NeoplasmPostoperative

Keywords

nutritional supportHepato-Biliary Neoplasmpostoperative curation

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (3)

Arm 1 - enteral nutrition

EXPERIMENTAL

patients receiving enteral nutrition (EN) after surgery

Dietary Supplement: enteral nutrition supplements

Arm 2 - parenteral nutrition

EXPERIMENTAL

patients receiving parenteral nutrition (PN)

Dietary Supplement: parenteral nutrition supplements

Arm 3 - mixed nutrition

EXPERIMENTAL

patients receiving mixed nutrition (MF)

Dietary Supplement: mixed nutrition supplements

Interventions

parenteral nutrition supplementsDIETARY_SUPPLEMENT

parenteral nutrition

Also known as: parenteral nutrition
Arm 2 - parenteral nutrition
enteral nutrition supplementsDIETARY_SUPPLEMENT

enteral nutrition

Also known as: enteral nutrition
Arm 1 - enteral nutrition
mixed nutrition supplementsDIETARY_SUPPLEMENT

mixed nutrition

Also known as: mixed nutrition
Arm 3 - mixed nutrition

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaganda Medical University

Karaganda, 100008, Kazakhstan

Location

MeSH Terms

Interventions

Parenteral NutritionEnteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Sherzad Davanov, MD

    Karaganda Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: prospective, longitudinal, parallel study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2024

First Posted

May 2, 2024

Study Start

December 1, 2017

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KA(1)