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2016-09
2017-12
2018-02
120
NCT03150615
Nanjing Medical University
Nanjing Medical University
INTERVENTIONAL
Enteral Nutrition After Pancreaticoduodenectomy
Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer. PD is still associated with a relatively a high incidence of delayed gastric emptying. And, there are no acknowledged strategies to avoid DGE. Several feeding strategies have been investigated to cope with this problem. However, there is still no consensus concerning the best nutrition support method after pancreaticoduodenectomy. The purpose of this study is to determine the effect of nutrition support methods on DGE after pancreaticoduodenectomy: early enteral nutrition or total parenteral nutrition. Patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group), or Saline administration (Saline group), or oral intake only (Natural control). The EN group will receive standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The Saline group will receive saline administered through a nasojejunal tube beginning from the 1st postoperative day. Oral intake will not be restricted in all three group.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-03-26 | N/A | 2019-07-11 |
2017-05-10 | N/A | 2019-07-12 |
2017-05-12 | N/A | 2019-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Early enteral nutrition Nasojejunal tube insertion was done intraopratively. Early enteral nutrition with standard enteral formulas administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate. | OTHER: Early enteral nutrition
DEVICE: nasojejunal tube insertion OTHER: Oral intake
|
| PLACEBO_COMPARATOR: Saline Group Nasojejunal tube insertion was done intraopratively. Saline was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate. | OTHER: Saline
DEVICE: nasojejunal tube insertion |
| OTHER: ERAS Group Nasojejunal tube insertion was done intraopratively. None was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate. | DEVICE: nasojejunal tube insertion OTHER: Oral intake
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incident rate of delayed gastric emptying | DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS. | 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Postoperative hospital stay length | 60 days | |
| Overall morbidity rate | 30 days | |
| Postoperative mortality rate | 30 days | |
| Rehospitalization rate | 60 days | |
| Infectious complications | 30 days | |
| Evaluation of the severity of the complications | according to classification of Dindo-Clavien | 30 days |
| Pancreatic fistulas | evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients | 30 days |
| Hemorrhagic complications | evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients | 30 days |
| Maximum Plasma Concentration fasting plasma GLP-1 level | Fasting plasma concentration GLP-1 level was monitored | Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
