Nutritional Support for Patients Operated for Malignant Tumors in HPD Zone

Karaganda Medical University

Status: Completed

Conditions: Hepato-Biliary Neoplasm; Nutritional Support; Postoperative

Treatments: Dietary Supplement: enteral nutrition supplements; Dietary Supplement: mixed nutrition supplements; Dietary Supplement: parenteral nutrition supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT06397430

MUK_NutS-HPD-PO_2017

Details and patient eligibility

About

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.

Full 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

Enrollment: 91 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

Arm 1 - enteral nutrition

Experimental group

Description:

patients receiving enteral nutrition (EN) after surgery

Treatment:

Dietary Supplement: enteral nutrition supplements

Arm 2 - parenteral nutrition

Experimental group

Description:

patients receiving parenteral nutrition (PN)

Treatment:

Dietary Supplement: parenteral nutrition supplements

Arm 3 - mixed nutrition

Experimental group

Description:

patients receiving mixed nutrition (MF)

Treatment:

Dietary Supplement: mixed nutrition supplements