Clinical trial NCT06397430: Nutritional Support for Patients Operated for Malignant Tumors in HPD Zone
Official title: Nutritional Support for Patients Operated on for Malignant Tumors of the Hepatico-pancreato-duodenal (HPD) Zone in the Early Postoperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Support
Hepato-Biliary Neoplasm
Postoperative
Keywords: nutritional support
Hepato-Biliary Neoplasm
postoperative curation
Lead sponsor: Karaganda Medical University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, longitudinal, parallel study
Primary purpose: OTHER

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with changes of BMI in kg/m^2
timeFrame: Day 0, Day 5, Day 10, Day15
measure: Basal Metabolic rate
timeFrame: Day 0, Day 5, Day 10, Day15
measure: Total protein level in Blood
timeFrame: Day 0, Day 5, Day 10, Day15
measure: Serum albumin in g/L
timeFrame: Day 0, Day 5, Day 10, Day15
measure: Serum transferrin in g/L
timeFrame: Day 0, Day 5, Day 10, Day15
measure: Total bilirubin in mmol/L
timeFrame: Day 0, Day 5, Day 10, Day15
measure: Direct bilirubin in mmol/L
timeFrame: Day 0, Day 5, Day 10, Day15
measure: ALT in IU/L
timeFrame: Day 0, Day 5, Day 10, Day15
measure: AST in IU/L
timeFrame: Day 0, Day 5, Day 10, Day15
Secondary outcomes:
Other outcomes:
Locations:
city: Karaganda
country: Kazakhstan
facility: Karaganda Medical University
Study officials:
affiliation: Karaganda Medical University
name: Sherzad Davanov, MD
role: PRINCIPAL_INVESTIGATOR
References: