NCT04704895

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

November 28, 2020

Last Update Submit

January 10, 2021

Conditions

Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Arm A: Total parenteral nutrition

ACTIVE COMPARATOR

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

Arm B: Enteral nutrition

EXPERIMENTAL

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

Interventions

Total parenteral nutritionDIETARY_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 A: Total parenteral nutrition
Enteral nutritionDIETARY_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.

Arm B: Enteral nutrition

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Sahnghai, 200032, China

Location

MeSH Terms

Interventions

Parenteral Nutrition, TotalEnteral Nutrition

Intervention Hierarchy (Ancestors)

Parenteral NutritionFeeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Central Study Contacts

Xianjun Yu, Phd

CONTACT

18019112906yuxianjun@fudanpci.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President of Pancreatic Cancer Institute

Study Record Dates

First Submitted

November 28, 2020

First Posted

January 12, 2021

Study Start

February 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 30, 2023

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

CN(1)