|Study title||A multi-centre evaluation of the post-gastrostomy management in patients with motor neurone disease|
|UK Chief Investigator||Professor Chris McDermott|
|Research summary||Motor neurone disease (MND) is a devastating terminal illness, causing a progressive weakness of muscles controlling movement, swallowing and breathing. Malnutrition and weight loss in patients with motor neurone disease (pwMND) are associated with increased disability and shortened survival, especially for those experiencing swallowing difficulties. Long-term nutritional support for patients with severe swallowing problems can be achieved by placing a feeding tube, known as a PEG, RIG, PIG, g-tube or gastrostomy, directly into the stomach.
Evidence from our previous research suggested the optimal method, and timing for, gastrostomy insertion in pwMND; however, there is lack of evidence to indicate the optimal ways for the nutritional management of patients, following gastrostomy insertion. This may explain the worrying finding we (and other studies) identified; that the majority of patients continue to lose weight or make insignificant gains in weight, in the first 3 months following gastrostomy insertion.
The aim of this study is to understand the reasons behind the poor nutritional outcomes following gastrostomy in the majority of pwMND and provide evidence-based recommendations for the nutritional management of this patient group. We plan to observe a group of 200 patients who have undergone gastrostomy in 22 MND care centres and clinics in the UK. Each participant, depending on disease progression, will take part in the study for 9 months following gastrostomy. We will prospectively collect information about the different post-gastrostomy nutritional approaches and their effectiveness on the nutritional state of patients with motor neurone disease. We will measure the nutritional outcome for patients (in terms of weight percentage, body mass index and lean body mass variation at 3, 6 and 9 months following gastrostomy and identify factors that may influence this outcome. Assessments will include measurements of weight, height, upper arm length and skin thickness; and the completion of a short questionnaire booklet.
|Inclusion/exclusion criteria||Inclusion Criteria:
1. Age > 18 years. 2. A diagnosis of amyotrophic lateral sclerosis (as defined by the El-Escorial criteria), primary muscular atrophy or progressive lateral sclerosis. 3. A decision has been taken to refer the patient for a gastrostomy, regardless of indication. 4. Participant is willing and able to give informed consent for participation in the study. If the participant is unable to provide written consent due to physical disability, an independent witness will be present at the informed consent discussion and sign the consent form on the participant’s behalf.
1. Age < 18 years. 2. Patient declines gastrostomy. 3. Contraindication to gastrostomy. 4. Underlying significant co-morbidity (e.g., thyroid disease, cancer or other disease) that would affect survival or metabolic state, independent of MND. 5. Patients who have undergone a successful gastrostomy (or are enterally fed via a nasogastric tube) before the start of the study. 6. Significant decision-making incapacity preventing informed consent by the potential participant because of a major mental disorder, such as major depression or schizophrenia, or dementia.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
|Current status||Active – recruiting|
Guy's and St Thomas' NHS Foundation Trust
LOROS hospice, Leicester
Royal Free Hospital (Lancashire)
Royal Preston Hospital
|Contact details||Coordinating centre: Haris Stavroulakis
Tel: 0114 2222267 Email: firstname.lastname@example.org
|Recruitment group(s)||Patients with MND|
|Recruitment target(s)||200 patients across the UK.|
|Key dates||Study start date: 13 April 2017
Target recruitment completion date: July 2020
|Sponsor||Sheffield Teaching Hospitals NHS Foundation Trust|
|Intervention (if applicable)||N/A|
|Phase (if applicable)||N/A|
|Outcome measures||Primary outcome measures: Change in weight percentage (%) at M3 following gastrostomy insertion.|
|Publications / Results reports|
|Participant Information Sheet|