Surgical Resection of an Upper Gastrointestinal MalignancyNCT02155140
Enteral Feeding in Discharged Patients
A study testing Jejunal feeding in people with Surgical Resection of an Upper Gastrointestinal Malignancy and Nutritional Supplementation Via a Jejunostomy Post Discharge From Hospital, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
Patients due to undergo surgery for oesophageal and gastric malignancy are often malnourished. Up to 10% of patients preoperative weight may also be lost during the early postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Resection of an Upper Gastrointestinal Malignancy, Nutritional Supplementation Via a Jejunostomy Post Discharge From Hospital
- What is being tested?
- Jejunal feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients able to give written informed consent,
- Have had a feeding jejunostomy placed at surgery,
- Competent (or their carer) to set up and use the jejunostomy feeding apparatus themselves.
Who cannot join
- Participating in another interventional trial,
- Age <18,
- Pre-operative BMI > 35,
- Pre-operative BMI <18,
- Oral intake at hospital discharge of > 90% of requirements,
- It is felt that they or their carers would not to cope with home tube feeding Patients unable to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8DH
About this study
Official title: Randomised Trial of Enteral Feeding in Patients Discharged From Hospital Following Surgical Resection of an Upper Gastrointestinal Malignancy
Patients due to undergo surgery for oesophageal and gastric malignancy are often malnourished. Up to 10% of patients preoperative weight may also be lost during the early postoperative period. Following discharge from hospital the mechanics of the surgery leads to a loss of gastric reservoir function, lack of appetite, altered intestinal motility and gastro-oesophageal reflux which usually results in reduced dietary intake and further weight loss. In patients who have undergone upper gastrointestinal resections there are no studies examining the benefit of nutritional supplementation following hospital discharge, however, studies in other groups of surgical patients have failed to show benefit. Despite patients who have undergone upper gastrointestinal surgery being 'at risk' nutritionally, there is no evidence demonstrating the value or not of nutritional supplementation following hospital discharge.
Hypothesis: The postoperative under nutrition seen after upper gastrointestinal surgery will exacerbate the reduced quality of life and fatigue patients' already experience. The investigators hypothesise that improving patient's nutritional intake following hospital discharge will improve their quality of life and fatigue levels.
Read the detailed description
For patients undergoing upper gastrointestinal (GI) surgery for cancer:
- Because of the nature of upper gastrointestinal surgery these patients have been shown to suffer undernutrition and weight loss after hospital discharge (up to 3 months) and to a greater extent than other groups of surgical patients. Quality of life and fatigue is a major issue after upper GI surgery.
- Nutritional supplementation via a jejunostomy after hospital discharge is only done routinely for all patients in 10%, and for selected patients in 20% of United Kingdom (UK) hospitals.
- Derriford hospital is very unusual in that 85% of patients are given home jejunal feeding.
- In Devon and Cornwall home enteral nutrition is delivered under contract by Fresenius Kabil (a global health care company).
- There are no studies of home nutritional supplementation in upper GI surgical patients.
- Studies of home nutritional supplementation in surgical patients having undergone colorectal surgery have not shown clinical or Quality of Life (QoL) benefit despite weight gain.
- The process of enteral nutrition may be associated with a reduction in quality of life.
- There is a need for a clinical trial to establish the benefit of home enteral nutritional supplementation. The results of any such trial may influence the highly variable nutritional present practice and may influence the surgeons desire to place a feeding jejunostomy (or not) at surgery which is associated with clinical complications.
- Conditions
- Surgical Resection of an Upper Gastrointestinal Malignancy, Nutritional Supplementation Via a Jejunostomy Post Discharge From Hospital
- Being tested
- Jejunal feeding
- Keywords
- enteral feeding, Discharged, surgical resection of an upper gastrointestinal malignancy, Nutritional supplementation via a jejunostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jejunal feedingDietary supplement
A feeding jejunostomy tube is inserted at the time of surgery to provide enteral nutritional support.
| Study group | Role | What they receive |
|---|---|---|
| Jejunal feeding | Active comparator | Nutritional supplementation via their jejunostomies for six weeks post hospital discharge, with continued assessment for a further 18 weeks. Receives: Dietary Supplement: Jejunal feeding |
| No jejunal feeding | No intervention | No jejunal feeding of patients for six weeks following hospital discharge, with continued assessment for a further 18 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
The primary outcome will therefore be fatigue as measured by the multidimensional fatigue inventory (MFI-20) score. The MFI-20 is divided into five scales: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue.
Measured: 18 weeks
Secondary outcomes (2)
Quality of life
We will use the oesophagus specific quality of life (QLQ-OES18) scale. The QLQ-OES18 scale is a disease specific Health-related quality of life (HRQL) questionnaire, designed to examine the influence of upper gastrointestinal pathology on patients and improvement in HRQL following treatment.
Measured: 18 weeks
Health economic analysis
Health economic analysis will be based on the EuroQol (EQ 5D) scale 4 (this scale defines health in terms of five dimensions: mobility, self care, usual activities, pain and anxiety).
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startFeb 2011
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Failed to recruit full number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Resection of an Upper Gastrointestinal MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen J Lewis, MBBS, MD, Study director, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155140
- Sponsor's protocol ID
- R&D 11/P/022
- Other IDs
- 10/H0106/80
- Status last verified
- Jan 2015
- First submitted
- 2 Jun 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Enteral Feeding in Patients Discharged From Hospital Following Surgical Resection of an Upper Gastrointestinal Malignancy
- ClinicalTrials.gov ID
- NCT02155140
- Acronym / sponsor ID
- R&D 11/P/022
- Conditions
- Surgical Resection of an Upper Gastrointestinal Malignancy, Nutritional Supplementation Via a Jejunostomy Post Discharge From Hospital
- Keywords
- enteral feeding, Discharged, surgical resection of an upper gastrointestinal malignancy, Nutritional supplementation via a jejunostomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to recruit full number of patients
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients due to undergo surgery for oesophageal and gastric malignancy are often malnourished. Up to 10% of patients preoperative weight may also be lost during the early postoperative period. Following discharge from hospital the mechanics of the surgery leads to a loss of gastric reservoir function, lack of appetite, altered intestinal motility and gastro-oesophageal reflux which usually results in reduced dietary intake and further weight loss. In patients who have undergone upper gastrointestinal resections there are no studies examining the benefit of nutritional supplementation following hospital discharge, however, studies in other groups of surgical patients have failed to show benefit. Despite patients who have undergone upper gastrointestinal surgery being 'at risk' nutritionally, there is no evidence demonstrating the value or not of nutritional supplementation following hospital discharge.
Hypothesis: The postoperative under nutrition seen after upper gastrointestinal surgery will exacerbate the reduced quality of life and fatigue patients' already experience. The investigators hypothesise that improving patient's nutritional intake following hospital discharge will improve their quality of life and fatigue levels.
Detailed description
For patients undergoing upper gastrointestinal (GI) surgery for cancer:
- Because of the nature of upper gastrointestinal surgery these patients have been shown to suffer undernutrition and weight loss after hospital discharge (up to 3 months) and to a greater extent than other groups of surgical patients. Quality of life and fatigue is a major issue after upper GI surgery.
- Nutritional supplementation via a jejunostomy after hospital discharge is only done routinely for all patients in 10%, and for selected patients in 20% of United Kingdom (UK) hospitals.
- Derriford hospital is very unusual in that 85% of patients are given home jejunal feeding.
- In Devon and Cornwall home enteral nutrition is delivered under contract by Fresenius Kabil (a global health care company).
- There are no studies of home nutritional supplementation in upper GI surgical patients.
- Studies of home nutritional supplementation in surgical patients having undergone colorectal surgery have not shown clinical or Quality of Life (QoL) benefit despite weight gain.
- The process of enteral nutrition may be associated with a reduction in quality of life.
- There is a need for a clinical trial to establish the benefit of home enteral nutritional supplementation. The results of any such trial may influence the highly variable nutritional present practice and may influence the surgeons desire to place a feeding jejunostomy (or not) at surgery which is associated with clinical complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jejunal feeding | Active comparator | Dietary Supplement: Jejunal feedingNutritional supplementation via their jejunostomies for six weeks post hospital discharge, with continued assessment for a further 18 weeks. |
| No jejunal feeding | No intervention | –No jejunal feeding of patients for six weeks following hospital discharge, with continued assessment for a further 18 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients able to give written informed consent,
- Have had a feeding jejunostomy placed at surgery,
- Competent (or their carer) to set up and use the jejunostomy feeding apparatus themselves.
Key exclusion criteria (6 listed)
- Participating in another interventional trial,
- Age <18,
- Pre-operative BMI > 35,
- Pre-operative BMI <18,
- Oral intake at hospital discharge of > 90% of requirements,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jejunal feedingA feeding jejunostomy tube is inserted at the time of surgery to provide enteral nutritional support. | Dietary supplement | Jejunal feeding |
Primary outcome
Fatigue
Time frame: 18 weeks
The primary outcome will therefore be fatigue as measured by the multidimensional fatigue inventory (MFI-20) score. The MFI-20 is divided into five scales: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue.
2 secondary outcomes
Quality of life
Time frame: 18 weeks
Health economic analysis
Time frame: 18 weeks
Results and safety
The study was stopped early (reason given: Failed to recruit full number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Lewis, MBBS, MD study director
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jejunal feeding in people with Surgical Resection of an Upper Gastrointestinal Malignancy and Nutritional Supplementation Via a Jejunostomy Post Discharge From Hospital, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failed to recruit full number of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.