An interventional study of Early enteral nutrition and Saline in Cancer of Pancreas, Cancer of Duodenum and Ampulla of Vater Cancer, sponsored by Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-12.
Sponsored by Nanjing Medical University · Not applicable, Interventional, and Prevention
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.
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Patients underwent selective pancreaticoduodenectomy Patients ≥18 years old and ≤80 years old Having given written informed consent
Exclusion Criteria:
Previous gastric resection or intestinal reconstruction Preoperative complete parenteral or enteral feeding ASA score ≥4 Pregnant women Severe malnutrition Patient who cannot give written informed consent.
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
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
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
Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament. Standard enteral diet, administered through a nasojejunal tube, is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. After PD, enteral nutrition liquid regimen will be used step by step from postoperative day 1 to postoperative day 7.Patients are targeted to receive calories for 25 kcal/kg/day. Meanwhile, oral food intake was not restricted.
Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament. After PPPD,Only Normal Saline were given through nasojejunal tube. Entral nutrition was not administrated. Patients intake food orally at will.
Also known as: Naso-jejunal tube will be placed intraoperatively.
Patients was encouraged to drink water on postoperative day 1, to eat liquid diet on postoperative day 2, to eat semi-solid on postoperative day 3, to eat solid food on postoperative day 4.
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.
Time frame: 30 days
Postoperative hospital stay length
Time frame: 60 days
Overall morbidity rate
Time frame: 30 days
Postoperative mortality rate
Time frame: 30 days
Rehospitalization rate
Time frame: 60 days
Infectious complications
Time frame: 30 days
Evaluation of the severity of the complications
according to classification of Dindo-Clavien
Time frame: 30 days
Pancreatic fistulas
evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients
Time frame: 30 days
Hemorrhagic complications
evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients
Time frame: 30 days
Maximum Plasma Concentration fasting plasma GLP-1 level
Fasting plasma concentration GLP-1 level was monitored
Time frame: Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Nanjing Medical University