Aug 4 2015
By Eleanor McDermid, Senior medwireNews Reporter
The ProGas study results show that three methods of gastrostomy are equally good in terms of complications and survival in patients with amyotrophic lateral sclerosis.
“In the absence of data from randomised trials, our findings might help neurologists, patients with amyotrophic lateral sclerosis, and the carers of patients with amyotrophic sclerosis to make decisions about the timing and method of gastrostomy”, write Christopher McDermott (University of Sheffield, UK) and colleagues.
The study researchers enrolled 330 patients who required gastrostomy. The type of procedure chosen was “based on practical and clinical considerations”, with 163 undergoing percutaneous endoscopic gastrostomy, 121 having radiologically inserted gastrostomy and 63 per-oral image-guided gastrostomy. Just three patients had surgical gastrostomy, so were not included in the analysis.
Complications were similar for the three procedures, except for more periprocedural distress in patients who underwent percutaneous endoscopic gastrostomy and more tube-related complications in those who received balloon-retention tubes, the team reports in The Lancet Neurology.
The main primary outcome, of 30-day mortality, did not significantly differ between the groups, at 3% each of the percutaneous endoscopic and radiologically inserted gastrostomy groups, and 7% of the per-oral image-guided gastrostomy patients. The median survival time after gastrostomy was 325 days, and also did not vary between the different procedures after accounting for treatment centre and other variables.
Instead, survival was independently determined by age at diagnosis and the degree of weight loss between diagnosis and gastrostomy. Indeed, the 30-day mortality risk was elevated 10.7-fold for patients who had lost more than 10% of their bodyweight, compared with those who had lost less weight. And the overall mortality risk was increased 2.5-fold, with median survival times of 12.0 and 7.7 months, respectively.
“These results suggest that patients might benefit from early gastrostomy, before substantial weight loss that might not be reversible”, says the team.
They suggest that a 5% bodyweight loss might be a better trigger for gastrostomy than the current guideline-recommended 10%. “Another recently suggested approach is to consider gastrostomy based on the ability of an individual to meet their total daily energy requirements.”
Regardless of the gastrostomy method, 49% of the 170 patients who were weighed 3 months after the procedure continued to lose weight, losing at least 1 kg. A quarter remained within 1 kg of their bodyweight at gastrostomy and a quarter gained weight, although the researchers say the median gain of 3.1 kg was “small and of doubtful clinical benefit”.
The team puts forward several possible reasons for the poor nutritional outcomes, including refractory cachexia, in which a patient with more than 5% weight loss has irreversible metabolic changes that render artificial nutritional support ineffective.
“This idea is well recognised in oncology but has not been explored in patients with amyotrophic lateral sclerosis”, they say.
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