Enteral Nutrition After Pancreaticoduodenectomy

Nanjing Medical University

Status: Completed

Conditions: Ampulla of Vater Cancer; Cancer of Pancreas; Cholangiocarcinoma; Cancer of Duodenum

Treatments: Other: Early enteral nutrition; Device: nasojejunal tube insertion; Other: Oral intake; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03150615

NMU-JSPH-PC-Nutrition

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups, including a placebo group

Early enteral nutrition

Experimental group

Description:

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.

Treatment:

Other: Early enteral nutrition

Other: Oral intake

Device: nasojejunal tube insertion

Saline Group

Placebo Comparator group

Description:

Nasojejunal tube insertion was done intraopratively. Saline was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.

Treatment:

Device: nasojejunal tube insertion

Other: Saline

ERAS Group

Other group

Description:

Nasojejunal tube insertion was done intraopratively. None was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.

Treatment:

Other: Oral intake

Device: nasojejunal tube insertion