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临床试验/NCT06397430
NCT06397430已完成不适用

Nutritional Support for Patients Operated on for Malignant Tumors of the Hepatico-pancreato-duodenal (HPD) Zone in the Early Postoperative Period

Karaganda Medical University1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Total protein level in Blood

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Arm 1 - enteral nutrition

Experimental

patients receiving enteral nutrition (EN) after surgery

干预措施: enteral nutrition supplements (Dietary Supplement)

Arm 2 - parenteral nutrition

Experimental

patients receiving parenteral nutrition (PN)

干预措施: parenteral nutrition supplements (Dietary Supplement)

Arm 3 - mixed nutrition

Experimental

patients receiving mixed nutrition (MF)

干预措施: mixed nutrition supplements (Dietary Supplement)

结局指标

主要结局

Total protein level in Blood

时间窗: Day 0, Day 5, Day 10, Day15

Blood biochemical analysis: total protein in g/L

ALT in IU/L

时间窗: Day 0, Day 5, Day 10, Day15

Blood biochemical analysis: ALT in IU/L

AST in IU/L

时间窗: Day 0, Day 5, Day 10, Day15

Blood biochemical analysis: AST in IU/L

Number of Participants with changes of BMI in kg/m^2

时间窗: Day 0, Day 5, Day 10, Day15

Variables of Body mass index measured by Canadian Guidelines for Body Weight Classification in Adults

Serum transferrin in g/L

时间窗: Day 0, Day 5, Day 10, Day15

Blood biochemical analysis: serum transferrin in g/L

Serum albumin in g/L

时间窗: Day 0, Day 5, Day 10, Day15

Blood biochemical analysis: serum albumin in g/L

Total bilirubin in mmol/L

时间窗: Day 0, Day 5, Day 10, Day15

Blood biochemical analysis: total bilirubin in mmol/L

Direct bilirubin in mmol/L

时间窗: Day 0, Day 5, Day 10, Day15

Blood biochemical analysis: direct bilirubin in mmol/L

Basal Metabolic rate

时间窗: Day 0, Day 5, Day 10, Day15

basal metabolic rate according to the Harris-Benedict equation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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