Clinical trial NCT03150615: Enteral Nutrition After Pancreaticoduodenectomy
Official title: Effect of Enteral Nutrition on Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Pancreas
Cancer of Duodenum
Ampulla of Vater Cancer
Cholangiocarcinoma
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incident rate of delayed gastric emptying
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative hospital stay length
timeFrame: 60 days
measure: Overall morbidity rate
timeFrame: 30 days
measure: Postoperative mortality rate
timeFrame: 30 days
measure: Rehospitalization rate
timeFrame: 60 days
measure: Infectious complications
timeFrame: 30 days
measure: Evaluation of the severity of the complications
timeFrame: 30 days
measure: Pancreatic fistulas
timeFrame: 30 days
measure: Hemorrhagic complications
timeFrame: 30 days
measure: Maximum Plasma Concentration fasting plasma GLP-1 level
timeFrame: Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The first affiliated hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
name: Yi Miao, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
name: Junli Wu, MD,PhD
role: STUDY_DIRECTOR
affiliation: Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
name: Jishu Wei, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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. doi: 10.1097/SLA.0000000000001896.
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.
citation: Liu X, Chen Q, Fu Y, Lu Z, Chen J, Guo F, Li Q, Wu J, Gao W, Jiang K, Dai C, Miao Y, Wei J. Early Nasojejunal Nutrition Versus Early Oral Feeding in Patients After Pancreaticoduodenectomy: A Randomized Controlled Trial. Front Oncol. 2021 Apr 29;11:656332. doi: 10.3389/fonc.2021.656332. eCollection 2021.