Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Enteral Nutrition
• Intervention / Treatment: Dietary supplement: Total parenteral nutrition; Dietary supplement: Enteral nutrition

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.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sahnghai
    • Shanghai, Sahnghai, China, 200032
      • Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	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
EXPERIMENTAL: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xian-Jun Yu

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: November 28, 2020
• First Submitted That Met QC Criteria: January 10, 2021
• First Posted (ACTUAL): January 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 10, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CSPAC-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No