Enteral Nutrition After Pancreaticoduodenectomy

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150615
• Other study ID #: NMU-JSPH-PC-Nutrition
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: February 2018

Study information

• Verified date: July 2019
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ampulla of Vater Cancer
• Cancer of Duodenum
• Cancer of Pancreas
• Cholangiocarcinoma
• Duodenal Neoplasms
• Pancreatic Neoplasms

Intervention

Other:
• Early enteral nutrition
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.
• Saline
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.

Device:
• nasojejunal tube insertion

Other:
• Oral 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.

Locations

Country	Name	City	State
China	The first affiliated hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

Lu JW, Liu C, Du ZQ, Liu XM, Lv Y, Zhang XF. Early enteral nutrition vs parenteral nutrition following pancreaticoduodenectomy: Experience from a single center. World J Gastroenterol. 2016 Apr 14;22(14):3821-8. doi: 10.3748/wjg.v22.i14.3821. — View Citation

Perinel J, Mariette C, Dousset B, Sielezneff I, Gainant A, Mabrut JY, Bin-Dorel S, Bechwaty ME, Delaunay D, Bernard L, Sauvanet A, Pocard M, Buc E, Adham M. Early Enteral Versus Total Parenteral Nutrition in Patients Undergoing Pancreaticoduodenectomy: A Randomized Multicenter Controlled Trial (Nutri-DPC). Ann Surg. 2016 Nov;264(5):731-737. — View Citation

Rayar M, Sulpice L, Meunier B, Boudjema K. Enteral nutrition reduces delayed gastric emptying after standard pancreaticoduodenectomy with child reconstruction. J Gastrointest Surg. 2012 May;16(5):1004-11. doi: 10.1007/s11605-012-1821-x. Epub 2012 Jan 19. — View Citation

Shen Y, Jin W. Early enteral nutrition after pancreatoduodenectomy: a meta-analysis of randomized controlled trials. Langenbecks Arch Surg. 2013 Aug;398(6):817-23. doi: 10.1007/s00423-013-1089-y. Epub 2013 May 22. Review. — View Citation

Zhu XH, Wu YF, Qiu YD, Jiang CP, Ding YT. Effect of early enteral combined with parenteral nutrition in patients undergoing pancreaticoduodenectomy. World J Gastroenterol. 2013 Sep 21;19(35):5889-96. doi: 10.3748/wjg.v19.i35.5889. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative hospital stay length		60 days
Secondary	Overall morbidity rate		30 days
Secondary	Postoperative mortality rate		30 days
Secondary	Rehospitalization rate		60 days
Secondary	Infectious complications		30 days
Secondary	Evaluation of the severity of the complications	according to classification of Dindo-Clavien	30 days
Secondary	Pancreatic fistulas	evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients	30 days
Secondary	Hemorrhagic complications	evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients	30 days
Secondary	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