Ampulla of Vater Cancer, Cancer of Duodenum, Cancer of Pancreas, Cholangiocarcinoma
Conditions
Brief summary
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.
Interventions
OTHERSaline
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.
DEVICEnasojejunal tube insertion
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.
OTHEROral intake
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.
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident rate of delayed gastric emptying | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall morbidity rate | 30 days | — |
| Postoperative mortality rate | 30 days | — |
| Rehospitalization rate | 60 days | — |
| Infectious complications | 30 days | — |
| Postoperative hospital stay length | 60 days | — |
| Pancreatic fistulas | 30 days | evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients |
| Hemorrhagic complications | 30 days | evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients |
| Maximum Plasma Concentration fasting plasma GLP-1 level | Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7 | Fasting plasma concentration GLP-1 level was monitored |
| Evaluation of the severity of the complications | 30 days | according to classification of Dindo-Clavien |
Countries
China
Outcome results
None listed