Nikhil A Kumta1, Amy Tyberg2, Vicky H Bhagat2, Ali A Siddiqui3, Thomas E Kowalski3, David E Loren3, Amit P Desai4, Alex M Sarkisian4, Elizabeth G Brown4, Kunal Karia4, Monica Gaidhane2, Prashant Kedia5, Paul R Tarnasky5, Umangi Patel5, Douglas Adler6, Linda J Taylor6, Maria Petrone7, Paolo Arcidiacono7, Patrick S Yachimski8, Douglas Weine9, Subha Sundararajan9, Pierre H Deprez10, Christina Mouradides10, Sammy Ho11, Safeera Javed11, Jeffrey J Easler12, Isaac Raijman13, Enrique Vazquez-Sequeiros14, Mandeep Sawhney15, Tyler M Berzin15, Michel Kahaleh16. 1. Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, United States. 2. Division of Gastroenterology, Robert Wood Johnson Medical School Rutgers University, New Brunswick, New Jersey, United States. 3. Division of Gastroenterology, Thomas Jefferson University Hospital, Philadelphia, PA Medicine, New York, NY, United States. 4. Division of Gastroenterology, New York Presbyterian Hospital - Weill Cornell, United States. 5. Methodist Dallas Medical Center, Dallas, TX, United States. 6. Division of Gastroenterology, University of Utah School of Medicine, Salt Lake City, UT, United States. 7. Division of Pancreato-Biliary Endoscopy and Endosonography, San Raffaele Scientific Institute, Milan, Italy. 8. Division of Gastroenterology, Vanderbilt University Medical Center, Nashville, TN, United States. 9. Riverview Medical Center, Red Bank Gastroenterology, Red Bank, NJ, United States. 10. Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium. 11. Division of Gastroenterology, Montefiore Medical Center, Bronx, NY, United States. 12. Division of Gastroenterology, Indiana University School of Medicine, Indianapolis, IN, United States. 13. Digestive Associates of Houston, St. Luke's Episcopal Hospital, Houston, TX, United States. 14. Division of Gastroenterology, University Hospital Ramón y Cajal, Madrid, Spain. 15. Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, United States. 16. Division of Gastroenterology, Robert Wood Johnson Medical School Rutgers University, New Brunswick, New Jersey, United States. Electronic address: mkahaleh@gmail.com.
Abstract
INTRODUCTION: Lumen apposing metal stents (LAMS) have been used increasingly for drainage of pancreatic fluid collections (PFC). We present an international, multicenter study evaluating the safety and efficacy of LAMS in PFCs. METHODS: Consecutive patients undergoing LAMS placement for PFC at 12 international centers were included (ClinicalTrials.gov NCT01522573). Demographics, clinical history, and procedural details were recorded. Technical success was defined as successful LAMS deployment. Clinical success was defined as PFC resolution at three-month follow-up. RESULTS: 192 patients were included (140 males (72.9%), mean-age 53.8 years), with mean follow-up of 4.2 months ± 3.8. Mean PFC size was 11.9 cm (range 2-25). The median number of endoscopic interventions was 2 (range 1-14). Etiologies for PFC were gallstone (n = 82, 42.7%), alcohol (n = 50, 26%), idiopathic (n = 26, 13.5%), and other (n = 34, 17.7%). Technical success was achieved in 189 patients (98.4%). Clinical success was observed in 125 of 135 patients (92.6%). Adverse events included bleeding (n = 11, 5.7), infection (n = 2, 1%), and perforation (n = 2, 1%). Three or more endoscopy sessions were a positive predictor for PFC resolution and the only significant predictor for AEs. CONCLUSION: LAMS has a high technical and clinical success rate with a low rate of AEs. PFC drainage via LAMS provides a minimally invasive, safe, and efficacious procedure for PFC resolution.
INTRODUCTION: Lumen apposing metal stents (LAMS) have been used increasingly for drainage of pancreatic fluid collections (PFC). We present an international, multicenter study evaluating the safety and efficacy of LAMS in PFCs. METHODS: Consecutive patients undergoing LAMS placement for PFC at 12 international centers were included (ClinicalTrials.gov NCT01522573). Demographics, clinical history, and procedural details were recorded. Technical success was defined as successful LAMS deployment. Clinical success was defined as PFC resolution at three-month follow-up. RESULTS: 192 patients were included (140 males (72.9%), mean-age 53.8 years), with mean follow-up of 4.2 months ± 3.8. Mean PFC size was 11.9 cm (range 2-25). The median number of endoscopic interventions was 2 (range 1-14). Etiologies for PFC were gallstone (n = 82, 42.7%), alcohol (n = 50, 26%), idiopathic (n = 26, 13.5%), and other (n = 34, 17.7%). Technical success was achieved in 189 patients (98.4%). Clinical success was observed in 125 of 135 patients (92.6%). Adverse events included bleeding (n = 11, 5.7), infection (n = 2, 1%), and perforation (n = 2, 1%). Three or more endoscopy sessions were a positive predictor for PFC resolution and the only significant predictor for AEs. CONCLUSION: LAMS has a high technical and clinical success rate with a low rate of AEs. PFC drainage via LAMS provides a minimally invasive, safe, and efficacious procedure for PFC resolution.