Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy

Enteral Nutrition Clinical Trial

Official title:

A Prospective RCT Study of Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04704895
• Other study ID #: CSPAC-32
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2021
• Source: Fudan University
• Contact: Xianjun Yu, Phd
• Phone: 18019112906
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 complications, and shorten the length of hospital stay

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: September 30, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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);

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

Dietary Supplement:
• Total parenteral nutrition
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
• Enteral nutrition
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.

Locations

Country	Name	City	State
China	Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Sahnghai

Sponsors (1)

Lead Sponsor	Collaborator
Xian-Jun Yu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with one or more postoperative complications (time range: 90 days) was observed, and data were recorded during the hospital stay (expected average of 3 weeks) and during control visits 3 months postoperatively.	The percentage of patients with one or more postoperative complications (time range: 90 days) was observed, and data were recorded during the hospital stay (expected average of 3 weeks) and during control visits 3 months postoperatively.	3month