Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy

December 3, 2014 updated by: University Hospitals, Leicester

A Pilot Study Investigating the Effect of Post-operative Home Jejunostomy Feeding on Quality of Life and Nutritional Parameters in Patients With Oesophago-gastric Cancer

After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in hospital. Current practice is to stop feeding once the patient leaves hospital, although the tube is left in place for the first 6 weeks. Most patients lose weight after surgery and have to learn to adjust to new eating habits and behaviours. A few patients have the JEJ feed restarted because of nutritional problems and this requires a further inpatient stay.

It is unknown whether every patient would benefit from this type of feeding at home. Previous studies have only assessed the value of JEJ feeding while patients are still in hospital. There is little known about the benefit of continuing JEJ feeding after discharge from hospital, although home feeding is not uncommon in other patient groups (eg. after a stroke).

The proposed study will provide initial information on patients' well being by measuring quality of life and factors such as change in body weight and dietary intake following a period of home JEJ feeding after surgery. Subjects recruited into the study will be placed, randomly, into a control group who receive current nutritional care (based on dietary advice and oral nutritional supplement drinks) or an intervention group who will receive home JEJ feeding for 6 weeks after hospital discharge, in addition to current treatment.

If subjects in the control group are experiencing problems eating at home, home feeding through the JEJ tube will be started as needed.

The study will also examine how surgery and JEJ feeding at home impact on the patient and carer(s) by means of questionnaires and interviews conducted in the patients' home.

Information obtained will assist in the design of a multicentre study. This intervention is considered important because it has the potential to benefit thousands of patients each year at a modest cost.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

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

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • University Hospitals of Leicester NHS Trust

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • planned esophagectomy or total gastrectomy for adenocarcinoma or squamous carcinoma
  • suitable for home enteral nutrition

Exclusion Criteria:

  • inability to provide written informed consent

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard care
Active Comparator: Home jejunostomy feeding
Six weeks of post hospital discharge home enteral feeding
Dietary supplement: Home jejunostomy feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant recruitment and retention rates
Time Frame: 7 months
This pilot study will inform the design and planning of a larger multi-centre study
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Variability in disease specific and generic quality of life measures will be assessed
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Time Frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Absolute body weight
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Health economics
Time Frame: 7 months
Estimates of healthcare costs for the duration of the study will be calculated
7 months
Readmission rates
Time Frame: 7 months
Readmission rate to hospital during the study period
7 months
Qualitative analysis
Time Frame: 8 weeks
Interviews will be conducted with up to 10 participants and their carers & thematic qualitative analysis of interviews performed
8 weeks
Food intake
Time Frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Self-completed 3 day food diaries will be assessed
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Time Frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Body mass index
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Time Frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Mid arm circumference
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Time Frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Triceps fold thickness
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Time Frame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Grip strength
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery

Collaborators and Investigators

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

Sponsor

University Hospitals, Leicester

Collaborators

University of Sheffield
University of Warwick
University of Leicester

Investigators

  • Study Director: DAVID J BOWREY, MD, University Hospitals, Leicester

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

Helpful Links

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

July 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34769
  • PB-PG-0610-22480 (Other Grant/Funding Number: UK NIHR Research for Patient Benefit)
  • 12447 (Other Identifier: UKCRN)

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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