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NCT Number: NCT03150615

Enteral Nutrition After Pancreaticoduodenectomy

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.

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Key information

Conditions

Cancer of Pancreas Adenocarcinoma Ampulla of Vater Cancer Cancer of Duodenum Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Duodenal Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early enteral nutrition

Other

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

Other

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.

nasojejunal tube insertion

Device

Other names: Naso-jejunal tube will be placed intraoperatively.

Oral intake

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative hospital stay length

    Time frame: 60 days

  2. Overall morbidity rate

    Time frame: 30 days

  3. Postoperative mortality rate

    Time frame: 30 days

  4. Rehospitalization rate

    Time frame: 60 days

  5. Infectious complications

    Time frame: 30 days

  6. Evaluation of the severity of the complications

    Time frame: 30 days

    according to classification of Dindo-Clavien

  7. Pancreatic fistulas

    Time frame: 30 days

    evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients

  8. Hemorrhagic complications

    Time frame: 30 days

    evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients

  9. Maximum Plasma Concentration fasting plasma GLP-1 level

    Time frame: Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7

    Fasting plasma concentration GLP-1 level was monitored

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 12, 2017
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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