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Enteral Nutrition After Pancreaticoduodenectomy

Primary Purpose

Cancer of Pancreas, Cancer of Duodenum, Ampulla of Vater Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Early enteral nutrition
Saline
nasojejunal tube insertion
Oral intake
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer of Pancreas

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The first affiliated hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Early enteral nutrition

Saline Group

ERAS Group

Arm 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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative hospital stay length
Overall morbidity rate
Postoperative mortality rate
Rehospitalization rate
Infectious complications
Evaluation of the severity of the complications
according to classification of Dindo-Clavien
Pancreatic fistulas
evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients
Hemorrhagic complications
evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients
Maximum Plasma Concentration fasting plasma GLP-1 level
Fasting plasma concentration GLP-1 level was monitored

Full Information

First Posted
March 26, 2017
Last Updated
July 11, 2019
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03150615
Brief Title
Enteral Nutrition After Pancreaticoduodenectomy
Official Title
Effect of Enteral Nutrition on Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Pancreas, Cancer of Duodenum, Ampulla of Vater Cancer, Cholangiocarcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early enteral nutrition
Arm Type
Experimental
Arm 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.
Arm Title
Saline Group
Arm Type
Placebo Comparator
Arm 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.
Arm Title
ERAS Group
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Early enteral nutrition
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
nasojejunal tube insertion
Other Intervention Name(s)
Naso-jejunal tube will be placed intraoperatively.
Intervention Type
Other
Intervention Name(s)
Oral intake
Intervention Description
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 Outcome Measure Information:
Title
Incident rate of delayed gastric emptying
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Postoperative hospital stay length
Time Frame
60 days
Title
Overall morbidity rate
Time Frame
30 days
Title
Postoperative mortality rate
Time Frame
30 days
Title
Rehospitalization rate
Time Frame
60 days
Title
Infectious complications
Time Frame
30 days
Title
Evaluation of the severity of the complications
Description
according to classification of Dindo-Clavien
Time Frame
30 days
Title
Pancreatic fistulas
Description
evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients
Time Frame
30 days
Title
Hemorrhagic complications
Description
evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients
Time Frame
30 days
Title
Maximum Plasma Concentration fasting plasma GLP-1 level
Description
Fasting plasma concentration GLP-1 level was monitored
Time Frame
Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Miao, Prof.
Organizational Affiliation
Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Junli Wu, MD,PhD
Organizational Affiliation
Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jishu Wei, MD,PhD
Organizational Affiliation
Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23695769
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.
Results Reference
background
PubMed Identifier
27076767
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.
Results Reference
background
PubMed Identifier
24124335
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.
Results Reference
background
PubMed Identifier
27429039
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.
Results Reference
background
PubMed Identifier
22258876
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.
Results Reference
background
PubMed Identifier
33996579
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.
Results Reference
derived

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Enteral Nutrition After Pancreaticoduodenectomy

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