Endoscopically placed stents have been demonstrated to successfully treat anastomotic and staple line leaks after bariatric surgery; nonetheless this remains an off-label indication for use in bariatric surgery as determined by the Food and Drug Administration (FDA). The extent to which stents have been adopted for the off-label management of bariatric complications in the United States remains unknown.
Data from the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) public use file (PUF) was analyzed for all postoperative interventions related to anastomotic or staple line leaks. These interventions were further evaluated for use of an endoscopically placed stent as a part of the management pathway. Patient and procedure level data, including preoperative demographics, comorbidities and procedure type, were compared between those who did and did not undergo stent placement. Categorical variables were compared using chi-squared analysis and Fisher’s Exact test, continuous variables were compared using student’s t-test, and ordinal values were compared using Wilcoxon rank-sum test.
In 2015, data from a total of 168,093 cases were collected for the MBSAQIP PUF. 3,126 (1.9%) patients required a postoperative intervention, including 330 (0.2%) for an anastomotic or staple line leak. Of these 330 patients, 143 (43.3%) had a stent placed. The median number of interventions for the all patients with leaks was 1, however the maximum was 8 for those treated with stents, and 4 for those without. In comparing leaks managed with stents to those without, we found that patients requiring a stent were more likely to have undergone a laparoscopic sleeve gastrectomy and less likely to have undergone a laparoscopic gastric bypass (63.6% vs 45.5% and 8.4% vs 33.7%, respectively, p<0.001). All other patient characteristics, including age, BMI and comorbidity status were statistically similar between the two groups.
Despite its off-label use classification, placement of stents for postoperative management of bariatric complications is commonplace and has become widely adopted throughout the United States. This is particularly true for patients with a staple line leak after sleeve gastrectomy. The off-label use designation; however, can have significant legal and financial implications. The widespread adoption coupled with robust clinical data demonstrating efficacy and safety, calls into question the need for policy change to expand the FDA approved indication of stents to include the management of complications following bariatric surgery.