Status:
UNKNOWN
Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy
Lead Sponsor:
Xian-Jun Yu
Conditions:
Enteral Nutrition
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To prove that early enteral nutrition after pancreaticoduodenal operation is of great significance to improve the immune response, reduce the incidence of postoperative infection and other related com...
Detailed Description
Arm A: Total parenteral nutrition. TPN also started from POD 1 and was delivered through a central venous catheter. Target energy of 1.5 amino acids/kg/day reached 30 kcal/kg/day. Arm B: NJEEN was de...
Eligibility Criteria
Inclusion
- Age between 18 and 80 years old, gender is not limited;
- All patients underwent pancreaticoduodenectomy;
- ECOG 0 \~ 2 for physical condition score;
- Imaging examination found pancreatic head, periampullary space, no distant metastasis and ascites;
- No bone marrow dysfunction;
- Those without obvious surgical contraindications;
- Expected postoperative survival ≥3 months;
- The study visit plan and other programme requirements are now available;
- Voluntary participation and signing of informed consent.
Exclusion
- Patients with stage II and IV periampullary carcinoma of head of pancreas and periampullary carcinoma;
- Active infected persons;
- Distant metastasis or ascites were found in imaging examination;
- Patients with serious impairment of heart, liver and kidney function (grade 3 to 4, ALT and/or AST more than 3 times the normal upper limit, Cr more than the normal upper limit);
- patients with other malignant tumors or blood diseases;
- Pregnancy, planned pregnancy and lactation female patients (urine HCG \>02500 iu /L, diagnosed as early pregnancy);
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04704895
Start Date
February 1 2021
End Date
September 30 2023
Last Update
January 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Sahnghai, China, 200032