Clinical trial NCT01870817: 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
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Neoplasms
Keywords: Randomized
Jejunostomy
Enteral
Nutrition
Esophagectomy
Gastrectomy
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: University of Leicester
name: University of Sheffield
name: University of Warwick
First posted: 2013-06-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Participant recruitment and retention rates
timeFrame: 7 months
Secondary outcomes:
measure: Quality of life
timeFrame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
measure: Nutritional parameters
timeFrame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
measure: Health economics
timeFrame: 7 months
measure: Readmission rates
timeFrame: 7 months
measure: Qualitative analysis
timeFrame: 8 weeks
measure: Food intake
timeFrame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
measure: Nutritional parameters
timeFrame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
measure: Nutritional parameters
timeFrame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
measure: Nutritional parameters
timeFrame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
measure: Nutritional parameters
timeFrame: Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
state: Leicestershire
Study officials:
affiliation: University Hospitals, Leicester
name: David J Bowrey, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.