Nutritional Support for Patients Operated for Malignant Tumors in HPD Zone

NCT ID: NCT06397430

Last Updated: 2024-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-02-28

Brief Summary

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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

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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

Conditions

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Nutritional Support Hepato-Biliary Neoplasm Postoperative

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

prospective, longitudinal, parallel study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arm 1 - enteral nutrition

patients receiving enteral nutrition (EN) after surgery

Group Type EXPERIMENTAL

enteral nutrition supplements

Intervention Type DIETARY_SUPPLEMENT

enteral nutrition

Arm 2 - parenteral nutrition

patients receiving parenteral nutrition (PN)

Group Type EXPERIMENTAL

parenteral nutrition supplements

Intervention Type DIETARY_SUPPLEMENT

parenteral nutrition

Arm 3 - mixed nutrition

patients receiving mixed nutrition (MF)

Group Type EXPERIMENTAL

mixed nutrition supplements

Intervention Type DIETARY_SUPPLEMENT

mixed nutrition

Interventions

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parenteral nutrition supplements

parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

enteral nutrition supplements

enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

mixed nutrition supplements

mixed nutrition

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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parenteral nutrition enteral nutrition mixed nutrition

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karaganda Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sherzad Davanov, MD

Role: PRINCIPAL_INVESTIGATOR

Karaganda Medical University

Locations

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Karaganda Medical University

Karaganda, , Kazakhstan

Site Status

Countries

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Kazakhstan

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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MUK_NutS-HPD-PO_2017

Identifier Type: -

Identifier Source: org_study_id

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