Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Esophageal Neoplasms

Intervention / Treatment
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* Dietary Supplement: Home jejunostomy feeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home jejunostomy feeding<br>Six weeks of post hospital discharge home enteral feeding | Dietary Supplement: Home jejunostomy feeding<br> <br> |
| No Intervention: Control<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized, Jejunostomy, Enteral, Nutrition, Esophagectomy, Gastrectomy