Treatment of malignant gastroduodenal obstruction with a nitinol self-expanding metal stent: an international prospective multicentre registry.

BACKGROUND: Duodenal stenting has become a broadly accepted first line of treatment for patients with advanced malignant gastroduodenal obstruction as these patients are difficult to treat and are poor surgical candidates. AIMS: To document duodenal stent performance for palliative management of malignant gastroduodenal obstruction. METHODS: Multicentre, single arm, prospective registry documenting peroral endoscopic duodenal stenting procedures in 202 patients. RESULTS: Technical success achieved in 98% (CI, 95%, 99%) of stent placements. Increase of Gastric Outlet Obstruction Score by at least 1 point compared to baseline was achieved in 91% (CI, 86%, 95%) of patients persisting for a median of 184 days (CI, 109, 266). By day 5 (CI, 4, 6) after stent placement, 50% of patients experienced a score increase of at least 1 point. Improvement from 14% of patients at baseline tolerating soft solids or low residue/normal diet to 84% at 15 days, 86% at 30 days, 81% at 90 days, 79% at 180 days, and 70% at 270 days. Complications included stent ingrowth and/or overgrowth (12.4%), transient periprocedural symptoms (3%), bleeding (3%), stent migration (1.5%), and perforation (0.5%). CONCLUSIONS: Safety and effectiveness of duodenal stenting for palliation of malignant gastroduodenal obstruction was confirmed in the largest international prospective series to date.

A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia.

OBJECTIVES: Self-expanding metal stents (SEMS) provide effective palliation in patients with malignant dysphagia, although severe complications and mortality may result. We performed a prospective controlled trial to compare a new self-expanding polyester mesh stent (Polyflex) with SEMS (Ultraflex). METHODS: One hundred one patients with unresectable esophageal carcinoma were randomized to placement of a Polyflex (N=47) or a partially covered Ultraflex (N=54) stent. Patients with esophagogastric junction (EGJ) malignancy were excluded. RESULTS: Placement was successful in 46 (98%) patients with the Polyflex and 54 (100%) patients with the Ultraflex stent. In one patient, the Polyflex stent could not be placed. After 1 wk, dysphagia was improved by at least 1 grade in 100% of the Polyflex group and in 94% of the Ultraflex group. Major complications were observed in 48% of the Polyflex group and 33% of the Ultraflex group. Intraprocedural perforation occurred in 1 Polyflex and 1 Ultraflex patient. Two Polyflex patients had postprocedural hemorrhage. Twenty (44%) patients with a Polyflex stent and 18 (33%) with an Ultraflex stent had recurrent dysphagia because of tumor overgrowth, stent migration, hyperplastic granulomatous reaction, or food bolus impaction. Multivariate analysis showed a significantly higher complication rate with Polyflex than with Ultraflex stents (odds ratio 2.3, 95% CI 1.2-4.4). However, median survival was 134 days with Polyflex and 122 days with Ultraflex stents (P=NS). CONCLUSIONS: No difference was seen in palliation of dysphagia between the two stents. Significantly more complications, especially late stent migration, were observed in the Polyflex group.

Polyflex stents for malignant oesophageal and oesophagogastric stricture: a prospective, multicentric study.

OBJECTIVE: Dysphagia is the most distressing symptom in patients with cancer-related oesophageal obstruction. Endoscopic palliation aims to restore swallowing, avoid reintervention and to reduce hospitalization. This study reports an experience with a new self-expandable plastic stent (Polyflex) in patients with unresectable oesophageal and oesophagogastric junction cancer. METHODS: Sixty patients were prospectively collected. The cause of obstruction was oesophageal squamous cell carcinoma (44) and adenocarcinoma (eight), lung cancer (seven) and thyroid tumour (one). RESULTS: The stent was successfully placed in 59 patients. Early minor complications occurred in 19 patients (32%), and major complications in 13 (22%). Death occurred in three patients owing to pulmonary embolism (one) and massive haemorrhage (two). Recurrent dysphagia for early stent migration was observed in seven patients. Delayed stent migration occurred in five patients and tumour overgrowth in eight patients. The mean dysphagia score of 2.8 improved to a mean score of 1.0 after stenting (P<0.001). Overall median survival time was 4.6 months. CONCLUSIONS: Our study suggests that Polyflex stents are competitive with metal stents, with similar efficacy but lower cost. Technical improvements, however, are required to make these stents more user friendly. Large randomized clinical studies are needed to guide in the choice among the different available stents.