Clinical Trial: Enteral Nutrition After Pancreaticoduodenectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Enteral Nutrition on Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial

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.


Detailed Summary:
Sponsor: Nanjing Medical University

Current Primary Outcome: Incident rate of delayed gastric emptying [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Postoperative hospital stay length [ Time Frame: 30 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 [ Time Frame: 30 days ]
    according to classification of Dindo-Clavien
  • Pancreatic fistulas [ Time Frame: 30 days ]
    evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients
  • Hemorrhagic complications [ Time Frame: 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 [ Time Frame: Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7 ]


Original Secondary Outcome: Same as current

Information By: Nanjing Medical University

Dates:
Date Received: March 26, 2017
Date Started: September 2016
Date Completion: June 2017
Last Updated: May 10, 2017
Last Verified: August 2016