Endoscopic variceal ligation is superior to combined ligation and sclerotherapy for esophageal varices: A multicenter prospective randomized trial |
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| Affiliation: | 1. Regional Institute of Gastroenterology and Hepatology “Octavian Fodor”, Hepatology Department and “Iuliu Hatieganu” University of Medicine and Pharmacy, 3rd Medical Clinic, Cluj-Napoca, Romania;2. Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clinic, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Health Care Provider of the European Reference Network on Rare Liver Disorders (ERN-Liver), Barcelona, Spain;3. Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi’an, China;4. Groupement Hospitalier Pitié-Salpêtrière-Charles Foix, Sorbonne University, Paris, France;5. Digestive Disease Department, Hospital Universitario Insular de Gran Canaria, Canary Islands;6. Medical Statistics Core Facility, Institut D’Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), Hospital Clinic Barcelona, Barcelona, Spain;8. Centro de Investigación Biomédica Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain;9. Hepatology, University Clinic for Visceral Surgery and Medicine, Inselspital, Bern University, Bern, Switzerland;11. Service d’Hépatogastro-entérologie, Centre Hospitalier Universitaire Purpan, Université 3 Paul Sabatier Toulouse, France;12. Department of Hepatology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium;13. Medizinische Klinik I, Klinikum Ludwigsburg, Ludwigsburg, Germany;14. Medical Department I, University of Bonn, Bonn, Germany;15. Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT), Palermo, Italy;16. Medizinische Klinik und Poliklinik für Gastroenterologie, Hepatologie, Infektiologie und Pneumologie, Universitätsklinikum Leipzig AöR, Leipzig, Germany;17. First Department of Internal Medicine, Martin Luther Universität Halle-Wittenberg Klinik, Halle, Germany;18. Department of lnterventional Radiology, Hospiral Universitario Insular de Gran Canaria, Canary Islands;19. Liver Hemodynamic Unit, Hospital Ramdn y Cajal, Madrid, Spain;20. Department of lnterventional Radiology, Hospital Ramdn y Cajal, Madrid, Spain;21. Digestive Diseases Department, IbiS, University Hospital Virgen del Rocío, Seville, Spain;22. Gastroenterology Unit, Ospedale A Cardarelli, Naples, Italy;23. Servei de Patologia Digestiva, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain;24. Servicio de Medicina de Aparato Digestivo Gregorio Marañón, Hospital General Universitario Gregorio Marañón, liSGM, Barcelona, Spain;25. Department of Gastroenterology, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), University of Alcalá, Madrid, Spain;26. Liver Unit, Hospital Universitari Vall d’Hebron, Vall d’Hebron Institute of Research (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain;27. European Foundation for the Study of Chronic Liver Failure (EF-Clif), Barcelona, Spain;28. Institute for Bioengineering of Catalonia, Barcelona, Spain;29. Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark;30. Liver Unit, Hospital U, Puerta de Hierro. Universidad Autònoma de Madrid, Madrid, Spain;31. Hospital General Universitario de Alicante, Alicante, Spain;32. Gastroenterology Department, Hepatology Unit, Hospital Universitari de Bellvitge, IDIBELL, Universitat de Barcelona, Barcelona, Spain;33. Gastroenterology and Hepatology Department, Centro Hospitalar São João, Porto, Portugal;34. Gastrounit, Medical Division, University Hospital of Hvidovre, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark;35. Serviço de Gastrenterologia e Hepatologia, Hospital de Santa Maria - Centro Hospitalar Lisboa Norte, Lisbon, Portugal;36. Liver Section, Gastroenterology Department, Hospital del Mar, Universitat Autònoma de Barcelona, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain;37. Department of Gastroenterology, Hospital Central de Asturias, Oviedo, Spain;38. St. John of God Hospital, Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria;39. Department of Gastroenterology, University Hospital San Cecilio, Granada, Spain;40. Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark;41. Gastroenterology Department, University Hospital of the Canary Islands, La Laguna, Tenerife, Spain;42. Unit of Gastroenterology and Digestive Endoscopy, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy;43. Gastroenterology Unit, ASST Fatebenefratelli Sacco, Department of Clinical and Biomedical Sciences, University of the Studies of Milan, Milan, Italy;44. Multivisceral Transplant Unit, Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University Hospital of Padua, Padua, Italy;45. Hepatology Unit, Hospital Universitario de Valme, Sevilla, Spain;46. Hepatology Unit, Digestive Disease Department Hospital de Sabadell, Universitat Autónoma de Barcelona, Sabadell, Spain;47. Hospital Universitari Germans Trias i Pujol, Universitat Autònoma Barcelona, Badalona, Spain;48. CRC “A. M. e A. Migliavacca” Center for Liver Disease Division of Gastroenterology and Hepatology IRCCS Ca'' Granda Maggiore Hospital FoundationUniversity of Milan, Milan, Italy;49. Department of gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, China;50. Department of Interventional Radiology, Nanfang Hospital, the Southern Medical University, Guangzhou, China;51. Department of Gastroenterology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China;52. Department of Interventional Radiology, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China;53. Department of Gastroenterology, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China;54. Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China;55. Hepatobiliary and Pancreatic Intervention Centre, Division of Hepatobiliary and Pancreatic Surgery, First affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China;56. Department of Vascular and Endovascular Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China;57. Department of Interventional Radiology, the First Affiliated Hospital of Xinjiang Medical University, Urumqi, China;58. Department of Interventional Radiology, the Second Affiliated Hospital of Kunming Medical University, Kunming, China;59. Department of Vascular Surgery, Henan Provincial People’s Hospital, Zhengzhou, China;60. Department of Interventional Radiology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China;61. State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi’an, China;1. Regional Institute of Gastroenterology and Hepatology “Octavian Fodor”, Hepatology Department and “Iuliu Hatieganu” University of Medicine and Pharmacy, 3rd Medical Clinic, Cluj-Napoca, Romania;2. Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clinic, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Health Care Provider of the European Reference Network on Rare Liver Disorders (ERN-Liver), Barcelona, Spain;3. Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi’an, China;4. Groupement Hospitalier Pitié-Salpêtrière-Charles Foix, Sorbonne University, Paris, France;5. Digestive Disease Department, Hospital Universitario Insular de Gran Canaria, Canary Islands;6. Medical Statistics Core Facility, Institut D’Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), Hospital Clinic Barcelona, Barcelona, Spain;7. Biostatistics Unit, Faculty of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain;8. Centro de Investigación Biomédica Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain;9. Hepatology, University Clinic for Visceral Surgery and Medicine, Inselspital, Bern University, Bern, Switzerland;10. State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi’an, China;1. Department of Gastroenterology, Hepatology, and Endocrinology, Cluster of Excellence RESIST (EXC 2155), Hannover, Germany;2. Hannover Medical School, Hannover, Germany;3. MYR GmbH, Bad Homburg, Germany;4. Department of Infectious Diseases and Molecular Virology, Heidelberg University Hospital, Heidelberg, Germany;5. Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany;6. Internal Medicine IV Gastroenterology, Heidelberg University Hospital, Heidelberg, Germany;7. Department of Internal Medicine I, Goethe University Hospital Frankfurt, Frankfurt, Germany;8. Hepatology Department, Moscow Regional Scientific Research, Clinic Institute MF Vladimirsky, Moscow, Russia;9. H-Clinic, Moscow, Russia;10. German Centre for Infection Research, Heidelberg, Germany;11. German Center for Infection Research (DZIF) partner site, Hannover-Braunschweig, Braunschweig, Germany;12. Modern Medicine Clinic, Moscow, Russia;13. Clinic of the South-Ural State Medical University, Chelyabinsk, Russia;14. Reference Centre for Viral Hepatitis, Central Research Institute of Epidemiology, Moscow, Russia;15. Novosibirsk State Medical University, Novosibirsk, Russia;p. Medical Company Hepatology, Samara, Russia;q. Stavropol State Medical University, Stavropol Regional Clinical Hospital, Stavropol, Russia;r. Department of Infectious Diseases, Physiology, Dermatology, and Venereology, Medical Institute of the North-Eastern Federal University MK Ammosov, Yakutsk, Russia;s. Gastroenterology and Dietology SM Riss, North-Western State Medical University, Mechnikov, Russia;t. Republican Clinical Infectious Diseases Hospital Professor AF Agafonov, Kazan, Russia;u. Infectious Clinical Hospital Number 1, Moscow City Department, Moscow, Russia;v. University Hospital Hamburg-Eppendorf, Centre for Internal Medicine, Medical Clinic and Polyclinic, Hamburg, Germany;w. German Centre for Infection Research, Hamburg-Lübeck-Borstel-Riems, Germany;x. Clinical Pharmacology, Dr Margarete Fischer-Bosch-Institute, Stuttgart, Germany;y. University of Tuübingen, Tuübingen, Germany;z. Departments of Clinical Pharmacology, Biochemistry, and Pharmacy, University Hospital Tübingen, Tübingen, Germany;1. Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy;2. CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy;3. AP-HP, Avicenne Hospital, Liver Unit, Sorbonne Paris Nord University, Bobigny, France;4. Inserm U955, Team 18, Paris-Est University, Créteil, France;5. Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover, Germany;6. Excellence Cluster RESIST, Hannover Medical School, Germany;7. German Center for Infection Research (DZIF), Partner Site Hannover-Braunschweig, Germany |
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| Abstract: | Patients who have bled from varices remain at risk for rebleeding. There is interest in methods that would enable rapid eradication of varices. The present trial was designed to study whether combining ligation with sclerotherapy will allow quicker eradication of varices than either modality alone. Patients with bleeding esophageal varices were randomized into ligation or combination therapy groups. Patients in the ligation group were treated with endoscopic rubber band ligation alone. In combination group patients, each variceal column was ligated distally and 1 mL of ethanolamine was injected proximal to each ligated site. Subsequent treatment sessions were at 7- to 14-day intervals until varices were eradicated. The clinical and endoscopic characteristics of 25 patients in the ligation group were similar to those of 22 patients in the combination group. Follow-up was up to 30 months. Active bleeding was controlled in 100% of patients in the ligation group and 75% of those in combination group (P = NS). It took 3.3 +/- .4 (range, 1-7) sessions to eradicate varices with ligation and 4.1 +/- .6 (1-7) with combination therapy (P = NS). Survival (four deaths in ligation group, 8 in combination group), rebleeding rate (25% vs. 36%), and varix recurrence (16% vs. 23%) also were similar. There were more complications with combination therapy, including deep ulcers (65% vs. 20%; P < .05); dysphagia (30% vs. 0%; P < .05), with three strictures requiring dilation; and pain (30% vs. 10%; P = NS). Our results show that sclerotherapy combined with ligation offers no benefit over ligation alone. The higher complication rate with combination therapy does not warrant this approach.(Hepatology 1997 Jan;25(1):71-4) |
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