Objective: To compare modified Gianturco metal stents with plastic Atkinson tubes in the palliation of malignant dysphagia.
Design: Patient single-blind, multi-centre prospective, randomized trial.
Setting: Three district general hospitals in the Wessex region.
Participants: Thirty one consecutive patients with inoperable malignant oesophageal stenosis causing dysphagia and suitable for treatment with an endoprosthesis.
Interventions: Patients were randomized to receive either a modified Gianturco metal stent or a plastic Atkinson tube. Sedation was similar and patients were given identical dietary advice. Data were collected after insertion until the patients' death.
Main outcome measures: Procedural mortality/morbidity; hospital stay; weight loss; quality of life (Nottingham Health Profile, Spitzer QL index and specific questions about dysphagia and enjoyment of food); duration of survival after insertion; cost effectiveness of each intervention.
Results: Overall complication rates were similar in the two groups. Compared with Atkinson tubes, patients with Gianturco stents had better palliation of dysphagia (median dysphagia score 1 vs 2, P = 0.04), maintained their weight longer (median percent weight loss 0.66 vs 6.51, P = 0.007), enjoyed food more (enjoyment score 2 vs 1, P = 0.03) and survived longer (log rank P < 0.025). Patients with metal stents were discharged from hospital earlier (Gianturco 4 days, Atkinson 10 days, P = 0.001), and initial treatment cost was lower if the cost of hospital stay exceeded pound sterling 120 per day.
Conclusion: Gianturco stents are superior to Atkinson tubes in the palliation of malignant oesophageal stenosis.