Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS

October 20, 2016 updated by: Zheng Chen, Xuzhou Medical University

A Prospective, Randomized Trial of Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS

Early oral intake after Pancreaticoduodenectomy is recommended strongly according to the ERAS guideline, which was based on studies in patients with gastrointestinal cancer, mainly colorectal and gastric. Specific clinical study on early oral intake after PD is very limited. inadequate nutritional intake was significantly associated with a high incidence of postoperative complications. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Enhanced Recovery After Surgery (ERAS) is an interdisciplinary, multimodal concept and has become an important focus of Pancreaticoduodenectomy procedures following universal accepted and practice in gastrointestinal and colorectal surgeries. Early oral diet without restrictions after operation is recommended strongly according to ERAS guideline. However, several studies demonstrated that only half validated the true practice of the postoperative oral diet. Furthermore, Oral intake tolerance after PD is controversial. Only 23% of patients were able to take solid food at day 3. It appears that adequate nutritional intake only via oral diet is a severe challenge. Besides, Studies showed that insufficient amount of dietary intake was significantly associated with extended duration of postoperative hospitalization and parenteral nutrition. Importantly, Specific clinical study on early oral intake after PD is very limited. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suqian, Jiangsu, China, 223800
        • Suqian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Periampullar carcinoma
  • Pancreaticoduodenectomy
  • ERAS protocol implemented

Exclusion Criteria:

  • Preoperative Radiotherapy/chemotherapy
  • Unresectable primary cancer
  • Palliative surgery
  • New York Heart Association class>3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1 early oral intake
early oral intake since postoperative day 1.
Procedure: early oral intake
early oral intake is started within 24 hours after pancreaticoduodenectomies following to the ERAS guideline
EXPERIMENTAL: 2 jejunostomy tube feeding (JTF)
jejunostomy tube feeding (JTF) was carried out after PD
Procedure: jejunostomy tube feeding (JTF)
The jejunostomy tube was placed using the Flocare CH-10 tube with the longitudinal Witzel jejunostomy technique.nutrition is supplemented via JTF rather than early oral intake.Velocity is progressively increased by 20ml/hr until full nutritional goal (25Kcal/Kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance of Oral Intake
Time Frame: postoperative 1 to 7day
the amount of oral intake is recorded, including clear fluids, soft and solid food.
postoperative 1 to 7day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morbidity rate
Time Frame: postoperative 1day to discharge, up to 8 weeks
complications associated with surgery, early oral intake,and jejunostomy tube.Definitions used for specific complications are according to the International Study Group on Pancreatic Fistula (ISGPF) definition.
postoperative 1day to discharge, up to 8 weeks
length of stay
Time Frame: postoperative 1day to discharge,up to 8 weeks
postoperative length of stay
postoperative 1day to discharge,up to 8 weeks
Readmission rate
Time Frame: 30 days after discharge
30 days after discharge
Hospital costs
Time Frame: postoperative 1day to discharge,up to 8 weeks
postoperative 1day to discharge,up to 8 weeks
Albumin
Time Frame: postoperative 30d
serum albumin
postoperative 30d
weight
Time Frame: postoperative 30d
weight in kilograms
postoperative 30d
height
Time Frame: postoperative 30d
height in meters
postoperative 30d

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Medical University

Collaborators

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: zheng chen, MD;PHD, Suqian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

October 16, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (ESTIMATE)

October 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • XuzhouMedSch

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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