An interventional study of 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber and Dietary mission in Liver Neoplasms, Nutrition Therapy and Hepatectomy, sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-01-06.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Prevention
Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection.
Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 200 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
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Exclusion Criteria:
300 or 500 calories nutritional support before operation according to the level of malnutrition
Dietary Supplement: 300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber · Behavioral: Dietary mission
Dietary education was conducted according to preoperative nutritional requirements
Behavioral: Dietary mission
300 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for Mild malnutrition, or 500 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for moderate to severe malnutrition. The degree of malnutrition is determined by Patient-Generated Subjective Global Assessment (PG-SGA).
Dietary education was conducted according to preoperative nutritional requirements
Incidence of complications at 30 days after surgery
Postoperative complications were defined by Clavien-Dindo. Grade 1： Any deviation from the normal postoperative course without the need for pharmacologic treatment or surgical, endoscopic, and radiologic interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgetics, and diuretics, and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade 2： Requiring pharmacologic treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade 3： Requiring surgical, endoscopic, or radiologic intervention 3a： Intervention not under general anesthesia 3b： Intervention under general anesthesia Grade 4：Life-threatening complication (including CNS complications) requiring IC/ICU management. 4a： Single organ dysfunction (including dialysis) 4b： Multiple organ dysfunction Grade 5： Death as a result of complications
Time frame: up to 30 days after surgery
Postoperative hospital stay
from the date of the operation to the date of discharge
Time frame: up to 90 days after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital