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Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy

Primary Purpose

Esophageal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Home jejunostomy feeding
Sponsored by
University Hospitals, Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Randomized, Jejunostomy, Enteral, Nutrition, Esophagectomy, Gastrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals of Leicester NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Home jejunostomy feeding

Control

Arm Description

Six weeks of post hospital discharge home enteral feeding

Standard care

Outcomes

Primary Outcome Measures

Participant recruitment and retention rates
This pilot study will inform the design and planning of a larger multi-centre study

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2013
Last Updated
December 3, 2014
Sponsor
University Hospitals, Leicester
Collaborators
University of Leicester, University of Sheffield, University of Warwick
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1. Study Identification

Unique Protocol Identification Number
NCT01870817
Brief Title
Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals, Leicester
Collaborators
University of Leicester, University of Sheffield, University of Warwick

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms
Keywords
Randomized, Jejunostomy, Enteral, Nutrition, Esophagectomy, Gastrectomy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Home jejunostomy feeding
Arm Type
Active Comparator
Arm Description
Six weeks of post hospital discharge home enteral feeding
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Dietary Supplement
Intervention Name(s)
Home jejunostomy feeding
Primary Outcome Measure Information:
Title
Participant recruitment and retention rates
Description
This pilot study will inform the design and planning of a larger multi-centre study
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
Variability in disease specific and generic quality of life measures will be assessed
Time Frame
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Title
Nutritional parameters
Description
Absolute body weight
Time Frame
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Title
Health economics
Description
Estimates of healthcare costs for the duration of the study will be calculated
Time Frame
7 months
Title
Readmission rates
Description
Readmission rate to hospital during the study period
Time Frame
7 months
Title
Qualitative analysis
Description
Interviews will be conducted with up to 10 participants and their carers & thematic qualitative analysis of interviews performed
Time Frame
8 weeks
Title
Food intake
Description
Self-completed 3 day food diaries will be assessed
Time Frame
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Title
Nutritional parameters
Description
Body mass index
Time Frame
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Title
Nutritional parameters
Description
Mid arm circumference
Time Frame
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Title
Nutritional parameters
Description
Triceps fold thickness
Time Frame
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Title
Nutritional parameters
Description
Grip strength
Time Frame
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Bowrey, MD
Organizational Affiliation
University Hospitals, Leicester
Official's Role
Study Director
Facility Information:
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28656968
Citation
Baker ML, Halliday V, Robinson P, Smith K, Bowrey DJ. Nutrient intake and contribution of home enteral nutrition to meeting nutritional requirements after oesophagectomy and total gastrectomy. Eur J Clin Nutr. 2017 Sep;71(9):1121-1128. doi: 10.1038/ejcn.2017.88. Epub 2017 Jun 28.
Results Reference
derived
PubMed Identifier
26590903
Citation
Bowrey DJ, Baker M, Halliday V, Thomas AL, Pulikottil-Jacob R, Smith K, Morris T, Ring A. A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study. Trials. 2015 Nov 21;16:531. doi: 10.1186/s13063-015-1053-y.
Results Reference
derived
PubMed Identifier
24885032
Citation
Bowrey DJ, Baker M, Halliday V, Thomas AL, Pulikottil-Jacob R, Smith K. Six weeks of home enteral nutrition versus standard care after esophagectomy or total gastrectomy for cancer: study protocol for a randomized controlled trial. Trials. 2014 May 24;15:187. doi: 10.1186/1745-6215-15-187.
Results Reference
derived
Links:
URL
http://www.ccf.nihr.ac.uk/RfPB/about/Pages/Abstract.aspx?ID=8046
Description
NHS National Institute for Health Research
URL
http://www.trialsjournal.com/content/15/1/187
Description
Published trial protocol

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Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy

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