Malignant esophageal dysphagia palliation using insertion of a covered Ultraflex stent without fluoroscopy: a prospective observational study.

Background: This study aimed to investigate the efficacy and safety of placing self-expandable metal stents (SEMSs) without fluoroscopy for palliation of malignant esophageal or esophagogastric strictures.

Methods: From January 2003 to June 2008, a prospective observational study investigated the placement of covered proximal-release Ultraflex stents without fluoroscopy in nonoperable malignant esophageal and esophagogastric strictures. The technical success as well as the early and late complications (perforation, migration, severe gastroesophageal reflux, hematemesis, and reobstruction due to tissue ingrowth or overgrowth) were recorded. Dysphagia before and after stent placement was scored on a 5-point scale. All the patients were observed monthly in the outpatient clinic or by telephone contact until death.

Results: The study enrolled 89 patients (16 women; mean age, 69.54±7.1 years) with dysphagia due to inoperable esophageal or esophagogastric malignant strictures (29 squamous cell cancers, 52 adenocarcinomas, and 8 obstructive malignant extrinsic compressions). The mean stricture length was 6.2±2.8 cm. Endoscopic deployment was achieved for 83 patients (93.2%), with accurate stent positioning in all the patients except one. An adequate relief of symptoms was noted for 82 of the patients (92.1%). During the follow-up period, 36 patients (43.4%) had recurrent dysphagia, caused by tumor overgrowth in 32 cases and stent migration in 4 cases, after an average time of 82 days (range 67-216 days). A stent-in-stent procedure was performed in 27 cases. For two patients, a third stent-in-stent needed to be placed after 85 and 216 days, respectively.

Conclusion: In most cases, SEMSs can be accurately and safely positioned without fluoroscopy for palliative treatment of malignant esophageal dysphagia.