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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

July 1, 2012

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed

9 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed

Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

May 28, 2013

Last Update Submit

December 3, 2014

Conditions

Esophageal Neoplasms

Keywords

RandomizedJejunostomyEnteralNutritionEsophagectomyGastrectomy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (10)

Quality of life
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Nutritional parameters
Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Health economics
7 months
Readmission rates
7 months
Qualitative analysis
8 weeks
+5 more secondary outcomes

Study Arms (2)