Safety and efficacy of a fully covered large-diameter self-expanding metal stent for the treatment of upper gastrointestinal perforations, anastomotic leaks, and fistula

Abstract

Upper gastrointestinal perforations, fistula, and anastomotic leaks are severe conditions with high mortality. Temporary endoscopic placement of fully covered self-expanding metal stent (fSEMS) has emerged as treatment option. Stent migration is a major drawback of currently used stents. Migration is often attributed to a relatively too small stent diameter as esophageal stents were initially intended for the treatment of strictures. This study aimed to investigate the safety and efficacy of a large-diameter fSEMS for treatment of these conditions. Data were retrospectively collected from patients who received this stent in the Netherlands between March 2011 and August 2013. Clinical success was defined as sufficient leak closure after stent removal as confirmed by endoscopy or X-ray with oral contrast without surgical intervention or placement of another type of stent. Adverse events were graded according a standardized grading system. Stent placement was performed in 34 patients for the following indications: perforation (n = 6), anastomotic leak (n = 26), and fistula (n = 2). Technical success rate was 97% (33/34). Clinical success rate was 44% (15/34) after one stent and 50% (17/34) after an additional stent. There were no severe adverse events and stent-related mortality. The overall adverse event rate was 50% (all graded 'moderate'). There were 14 (41%) stent migrations (complete n = 8, partial n = 6). Other adverse events were bleeding (n = 2) and aspiration pneumonia (n = 1). Reinterventions for failure of the large-diameter fSEMS were placement of another type of fSEMS (n = 4), surgical repair (n = 3), or esophagectomy (n = 1). Eleven patients (32%) died in-hospital because of persisting intrathoracic sepsis (n = 10) or preexistent bowel ischemia (n = 1). This study suggests that temporary placement of a large-diameter fSEMS for the treatment of upper gastrointestinal perforations, fistula, and anastomotic leaks is safe in terms of severe adverse events and stent-related mortality. The larger diameter does not seem to prevent stent migration.

Treatment of Postoperative Leaks of the Upper Gastrointestinal Tract with Colonic Self-Expandable Metal Stents

“…This advantage is of particular importance after upper GI surgery, especially after esophageal resections, where a larger postoperative lumen of the GI tract is found without an obstructive lesion to keep the stent in place. On the other hand, there may also be a greater risk of adverse events [4][5][6]10] . Our study suggests that placement and removal of colonic FSEMS are effective and safe in this particularly difficult group of patients.…”

“…In a multicenter study, van den Berg et al [10] evaluated the safety and efficacy of the placement of a Hanarostent ® CCI for the treatment of upper GI perforations, anastomotic leaks, and fistula; the same stent was used in our series. Of the 34 patients treated, there was technical success in 97% and clinical success in 50% of the patients.…”

“…It should be noted that for a successful endoscopic procedure, a complete drainage of fluid collections in the mediastinum or pleural cavity is fundamental [4-6, 10, 11] . There are 2 major drawbacks associated with stent placement, namely stent migration, which may occur in 13-46% of the patients [10] , and tissue in-or overgrowth. This latter complication has been reported to occur more commonly with PSEMS than with FSEMS or SEPS.…”

“…On the one hand, the reactive tissue growing into the stent meshes may reduce the risk of stent migration and provide a better watertight barrier to luminal contents, favoring fistula healing. On the other hand, severe tissue embedding may cause difficulties in endoscopic stent removal [4,7,10] .…”

“…Therefore, there is a discrepancy between the small diameters of commercially available stents and the larger diameter of the upper GI tract after surgery. This may preclude a desired watertight sealing in this particular group of patients and a higher risk of migration [10,11] . In the absence of stents specifically designed for altered postoperative anatomy, an option to prevent stent migration may be the utilization of a stent with a larger diameter, as is the case with stents designed for the colon.…”