Sundeep Lakhtakia1, Nageshwar Reddy1, Werner Dolak2, Thierry Ponchon3, Marco J Bruno4, Michael J Bourke5, Horst Neuhaus6, André Roy7, Ferrán González-Huix Lladó8, Paul P Kortan9, Joyce Peetermans10, Matthew Rousseau11, Guido Costamagna12, Jacques Devière13. 1. Gastroenterology and Therapeutic Endoscopy, Asian Institute of Gastroenterology, Hyderabad, India. 2. Klinische Abteilung für Gastroenterologie und Hepatologie, Universitätsklinik für Innere Medizin III, Medizinische Universität Wien, Vienna, Austria. 3. Service de Gastroentérologie et d'Endoscopie Digestive, Hôpital Edouard Herriot, Lyon, France. 4. Maag-, Darm- en Leverziekten, Erasmus Universitair Medisch Centrum, Rotterdam, The Netherlands. 5. Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, New South Wales, Australia. 6. Medizinische Klinik, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany. 7. Département de Chirurgie, Hôpital Saint-Luc, Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada. 8. Unidad de Endoscopia, Servicio de Aparato Digestivo, Hospital Universitari Doctor Josep Trueta, Girona, Catalunya, Spain. 9. Division of Gastroenterology, Centre for Therapeutic Endoscopy and Endoscopic Oncology, St Michael's Hospital, Toronto, Ontario, Canada. 10. Maag-, Darm- en Leverziekten, Erasmus Universitair Medisch Centrum, Rotterdam, The Netherlands; Endoscopy Division, Boston Scientific Corp, Marlborough, Massachusetts, USA. 11. Endoscopy Division, Boston Scientific Corp, Marlborough, Massachusetts, USA. 12. Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli - IRCCS, Catholic University, Rome, Italy; Digestive Endoscopy, IHU-USIAS, University of Strasbourg, Strasbourg, France. 13. Service de Gastro-Entérologie et d'Hépato Pancréatologie, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
Abstract
BACKGROUND AND AIMS: Temporary single, fully covered self-expanding metal stent (FCSEMS) placement for benign biliary strictures (BBSs) associated with chronic pancreatitis (CP) may require fewer interventions than endotherapy with multiple plastic stents and may carry less morbidity than biliary diversion surgery. This study aimed to assess long-term outcomes in CP-associated BBSs after FCSEMS placement and removal. METHODS: In this open-label, multinational, prospective study, subjects with CP and a BBS treated with FCSEMS placement with scheduled removal at 10 to 12 months were followed for 5 years after FCSEMS indwell. Kaplan-Meier analyses assessed BBS resolution and cumulative probability of freedom from recurrent stent placement to 5 years after FCSEMS indwell. RESULTS: One hundred eighteen patients were eligible for FCSEMS removal. At a median of 58 months (interquartile range, 44-64) post-FCSEMS indwell, the probability of remaining stent-free was 61.6% (95% confidence interval [CI], 52.5%-70.7%). In 94 patients whose BBSs resolved at the end of FCSEMS indwell, the probability of remaining stent-free 5 years later was 77.4% (95% CI, 68.4%-86.4%). Serious stent-related adverse events occurred in 27 of 118 patients (22.9%); all resolved with medical therapy or repeated endoscopy. Multivariate analysis identified severe CP (hazard ratio, 2.4; 95% CI, 1.0-5.6; P = .046) and longer stricture length (hazard ratio, 1.2; 95% CI, 1.0-1.4; P = .022) as predictors of stricture recurrence. CONCLUSION: In patients with symptomatic BBSs secondary to CP, 5 years after placement of a single FCSEMS intended for 10 to 12 months indwell, more than 60% remained asymptomatic and stent-free with an acceptable safety profile. Temporary placement of a single FCSEMS may be considered as first-line treatment for patients with CP and BBSs. (Clinical trial registration number: NCT01014390.).
BACKGROUND AND AIMS: Temporary single, fully covered self-expanding metal stent (FCSEMS) placement for benign biliary strictures (BBSs) associated with chronic pancreatitis (CP) may require fewer interventions than endotherapy with multiple plastic stents and may carry less morbidity than biliary diversion surgery. This study aimed to assess long-term outcomes in CP-associated BBSs after FCSEMS placement and removal. METHODS: In this open-label, multinational, prospective study, subjects with CP and a BBS treated with FCSEMS placement with scheduled removal at 10 to 12 months were followed for 5 years after FCSEMS indwell. Kaplan-Meier analyses assessed BBS resolution and cumulative probability of freedom from recurrent stent placement to 5 years after FCSEMS indwell. RESULTS: One hundred eighteen patients were eligible for FCSEMS removal. At a median of 58 months (interquartile range, 44-64) post-FCSEMS indwell, the probability of remaining stent-free was 61.6% (95% confidence interval [CI], 52.5%-70.7%). In 94 patients whose BBSs resolved at the end of FCSEMS indwell, the probability of remaining stent-free 5 years later was 77.4% (95% CI, 68.4%-86.4%). Serious stent-related adverse events occurred in 27 of 118 patients (22.9%); all resolved with medical therapy or repeated endoscopy. Multivariate analysis identified severe CP (hazard ratio, 2.4; 95% CI, 1.0-5.6; P = .046) and longer stricture length (hazard ratio, 1.2; 95% CI, 1.0-1.4; P = .022) as predictors of stricture recurrence. CONCLUSION: In patients with symptomatic BBSs secondary to CP, 5 years after placement of a single FCSEMS intended for 10 to 12 months indwell, more than 60% remained asymptomatic and stent-free with an acceptable safety profile. Temporary placement of a single FCSEMS may be considered as first-line treatment for patients with CP and BBSs. (Clinical trial registration number: NCT01014390.).
Authors: Marko Murruste; Ülle Kirsimägi; Karri Kase; Tatjana Veršinina; Peep Talving; Urmas Lepner Journal: World J Clin Cases Date: 2022-08-06 Impact factor: 1.534