Home Jejunostomy Feeding Following Esophagectomy/Gastrectomy

Esophageal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870817
• Other study ID #: 34769
• Secondary ID: PB-PG-0610-22480
• Status: Completed
• Phase: N/A
• First received: May 28, 2013
• Last updated: December 3, 2014
• Start date: July 2012
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Dietary Supplement:
• Home jejunostomy feeding

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester	Leicestershire

Sponsors (4)

Lead Sponsor	Collaborator
University Hospitals, Leicester	University of Leicester, University of Sheffield, University of Warwick

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant recruitment and retention rates	This pilot study will inform the design and planning of a larger multi-centre study	7 months	No
Secondary	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	No
Secondary	Nutritional parameters	Absolute body weight	Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery	No
Secondary	Health economics	Estimates of healthcare costs for the duration of the study will be calculated	7 months	No
Secondary	Readmission rates	Readmission rate to hospital during the study period	7 months	No
Secondary	Qualitative analysis	Interviews will be conducted with up to 10 participants and their carers & thematic qualitative analysis of interviews performed	8 weeks	No
Secondary	Food intake	Self-completed 3 day food diaries will be assessed	Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery	No
Secondary	Nutritional parameters	Body mass index	Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery	No
Secondary	Nutritional parameters	Mid arm circumference	Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery	No
Secondary	Nutritional parameters	Triceps fold thickness	Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery	No
Secondary	Nutritional parameters	Grip strength	Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery	No

External Links

•   NHS National Institute for Health Research
•   Published trial protocol
•   UK Clinical Research Network Study Portfolio
•   UK Clinical Research Network Study Portfolio