OBJECTIVES: A prospective randomised study of patients with irresectable oesophageal carcinoma treated withself-expandable covered metal Wallstent and plastic Procter Livingstone tubes was performed. The purpose was to compare the efficacy, cost effectiveness, ease of implantation, long-term patency and complications of the two different stents. METHODS: Data recorded included dysphagia score (0-4) the day before and after stent placement, location and length of stricture, procedural time and complications, and stent patency at 1 and 3 months' follow-up. A comparative costing of materials, theatre and anaesthetic time and hospital stay was undertaken. RESULTS:Forty patients were studied over 12 months (20 in each group). Strictures were located most commonly in the middle third of the oesophagus (75%), followed by the upper third (12.5%) and lower third (12.5%). Mean stricture length was 6 cm (2-12 cm); 10 patients (25%) had strictures 8 cm or longer. Five patients had tracheo-oesophageal fistulas (3 Wallstent; 2 Procter Livingstone tube). There was effective fistula sealing in all 3 Wallstent patients, and non-sealing in 1 of the Procter Livingstone patients. The mean pre-operative dysphagia score in both groups was 3, and immediately postoperatively the score was 0 in the Wallstent group and 2 in the plastic tube group. Initial stent placement was satisfactory in all Wallstent patients, with 2 patients requiring 2 stents each for adequate tumour coverage, and in 15 patients (75%) having plastic stents. Immediate complications were chest pain in 2 patients with Wallstents and oesophageal perforation in 2 patients (10%) with plastic stents. Wallstent patency at 1 and 3 months was 90% and 88%, respectively, and plastic stent patency was 66% and 50%. Four patients (10%), 2 in each group, died during the study from massive tumour load or metastatic disease. Comparative costing of the Wallstent versus the plastic tube stent was R4 123 versus R2 146 or a factor of 1.9. CONCLUSION: Palliation with the Wallstent is effective, with excellent 1- and 3-month patency. The Wallstent is superior to the conventional plastic stent in terms of ease of implantation, better long-term patency and fewer complications. It is particularly useful for the treatment of patients with fistulas and long strictures. Accurate placement is critical in order to prevent stent migration and tumour overgrowth. However, it costs almost twice as much to implant the Wallstent as it does to implant the plastic tube.
RCT Entities:
OBJECTIVES: A prospective randomised study of patients with irresectable oesophageal carcinoma treated with self-expandable covered metal Wallstent and plastic Procter Livingstone tubes was performed. The purpose was to compare the efficacy, cost effectiveness, ease of implantation, long-term patency and complications of the two different stents. METHODS: Data recorded included dysphagia score (0-4) the day before and after stent placement, location and length of stricture, procedural time and complications, and stent patency at 1 and 3 months' follow-up. A comparative costing of materials, theatre and anaesthetic time and hospital stay was undertaken. RESULTS: Forty patients were studied over 12 months (20 in each group). Strictures were located most commonly in the middle third of the oesophagus (75%), followed by the upper third (12.5%) and lower third (12.5%). Mean stricture length was 6 cm (2-12 cm); 10 patients (25%) had strictures 8 cm or longer. Five patients had tracheo-oesophageal fistulas (3 Wallstent; 2 Procter Livingstone tube). There was effective fistula sealing in all 3 Wallstent patients, and non-sealing in 1 of the Procter Livingstone patients. The mean pre-operative dysphagia score in both groups was 3, and immediately postoperatively the score was 0 in the Wallstent group and 2 in the plastic tube group. Initial stent placement was satisfactory in all Wallstent patients, with 2 patients requiring 2 stents each for adequate tumour coverage, and in 15 patients (75%) having plastic stents. Immediate complications were chest pain in 2 patients with Wallstents and oesophageal perforation in 2 patients (10%) with plastic stents. Wallstent patency at 1 and 3 months was 90% and 88%, respectively, and plastic stent patency was 66% and 50%. Four patients (10%), 2 in each group, died during the study from massive tumour load or metastatic disease. Comparative costing of the Wallstent versus the plastic tube stent was R4 123 versus R2 146 or a factor of 1.9. CONCLUSION: Palliation with the Wallstent is effective, with excellent 1- and 3-month patency. The Wallstent is superior to the conventional plastic stent in terms of ease of implantation, better long-term patency and fewer complications. It is particularly useful for the treatment of patients with fistulas and long strictures. Accurate placement is critical in order to prevent stent migration and tumour overgrowth. However, it costs almost twice as much to implant the Wallstent as it does to implant the plastic tube.
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