Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy

NCT ID: NCT04704895

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-09-30

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 complications, and shorten the length of hospital stay

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 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.

Conditions

Enteral Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm A: 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

Group Type: ACTIVE_COMPARATOR

Total parenteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

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

Arm B: 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.

Group Type: EXPERIMENTAL

Enteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xian-Jun Yu

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

President of Pancreatic Cancer Institute

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Sahnghai, China

Countries

China

Central Contacts

Xianjun Yu, Phd

Role: CONTACT

yuxianjun@fudanpci.org

18019112906

Facility Contacts

Xianjun Yu, Phd

Role: primary

Other Identifiers

CSPAC-32

Identifier Type: -

Identifier Source: org_study_id