Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy

Xian-Jun Yu

Status: Unknown

Conditions: Enteral Nutrition

Treatments: Dietary Supplement: Total parenteral nutrition; Dietary Supplement: Enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT04704895

CSPAC-32

Details and patient eligibility

About

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 complications, and shorten the length of hospital stay

Full 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 defined as providing at least 50% of the nutritional requirements through the nasojejunal tube prior to the 5th day after surgery (POD) and having no parenteral nutrition for 72 h or more.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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);

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Arm A: Total parenteral nutrition

Active Comparator group

Description:

Total parenteral nutrition, TPN also starts from POD 1 and is delivered through a central venous catheter, with a target energy of 1.5 amino acids/kg/day reaching 30 kcal/kg/day

Treatment:

Dietary Supplement: Total parenteral nutrition

Arm B: Enteral nutrition

Experimental group

Description:

NJEEN was defined as providing at least 50% of the nutritional requirements through the nasojejunal tube prior to the 5th day after surgery (POD) and having no parenteral nutrition for 72 hours or more.

Treatment:

Dietary Supplement: Enteral nutrition