Milan S Bassan1, Praka Sundaralingam1, Scott B Fanning1, James Lau2, Jayaram Menon3, Evan Ong4, Rungsun Rerknimitr5, Dong-Wan Seo6, Eng Kiong Teo7, Hsiu-Po Wang8, D Nageshwar Reddy9, Khean Lee Goh10, Michael J Bourke11. 1. Department of Gastroenterology and Hepatology, Westmead Hospital, New South Wales, Australia. 2. Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China. 3. Department of Gastroenterology, Kota Kinabalu Hospital, Kota Kinabalu, Malaysia. 4. Gastroenterology Section, Metropolitan Medical Centre, Manila, Philippines. 5. Gastrointestinal Endoscopy Excellence Centre, Department of Medicine, Chulalongkorn University Hospital, Bangkok, Thailand. 6. Department of Gastroenterology, Asan Medical Centre, Seoul, South Korea. 7. Department of Gastroenterology, Changi General Hospital, Singapore. 8. Endoscopy Division, National Taiwan University Hospital, Taipei, Taiwan. 9. Asian Institute of Gastroenterology, Hyderabad, India. 10. Department of Gastroenterology and Hepatology, University of Malaya Medical Centre, Pantai Dalam, Kuala Lumpur, Malaysia. 11. Department of Gastroenterology and Hepatology, Westmead Hospital, New South Wales, Australia; The University of Sydney, Sydney, New South Wales, Australia.
Abstract
BACKGROUND AND AIMS: Wire-guided biliary cannulation has been demonstrated to improve cannulation rates and reduce post-ERCP pancreatitis (PEP), but the impact of wire caliber has not been studied. This study compares successful cannulation rates and ERCP adverse events by using a 0.025-inch and 0.035-inch guidewire. METHODS: A randomized, single blinded, prospective, multicenter trial at 9 high-volume tertiary-care referral centers in the Asia-Pacific region was performed. Patients with an intact papilla and conventional anatomy who did not have malignancy in the head of the pancreas or ampulla and were undergoing ERCP were recruited. ERCP was performed by using a standardized cannulation algorithm, and patients were randomized to either a 0.025-inch or 0.035-inch guidewire. The primary outcomes of the study were successful wire-guided cannulation and the incidence of PEP. Overall successful cannulation and ERCP adverse events also were studied. RESULTS:A total of 710 patients were enrolled in the study. The primary wire-guided biliary cannulation rate was similar in 0.025-inch and 0.035-inch wire groups (80.7% vs 80.3%; P = .90). The rate of PEP between the 0.025-inch and the 0.035-inch wire groups did not differ significantly (7.8% vs 9.3%; P = .51). No differences were noted in secondary outcomes. CONCLUSION: Similar rates of successful cannulation and PEP were demonstrated in the use of 0.025-inch and 0.035-inch guidewires. (Clinical trial registration number: NCT01408264.).
RCT Entities:
BACKGROUND AND AIMS: Wire-guided biliary cannulation has been demonstrated to improve cannulation rates and reduce post-ERCP pancreatitis (PEP), but the impact of wire caliber has not been studied. This study compares successful cannulation rates and ERCP adverse events by using a 0.025-inch and 0.035-inch guidewire. METHODS: A randomized, single blinded, prospective, multicenter trial at 9 high-volume tertiary-care referral centers in the Asia-Pacific region was performed. Patients with an intact papilla and conventional anatomy who did not have malignancy in the head of the pancreas or ampulla and were undergoing ERCP were recruited. ERCP was performed by using a standardized cannulation algorithm, and patients were randomized to either a 0.025-inch or 0.035-inch guidewire. The primary outcomes of the study were successful wire-guided cannulation and the incidence of PEP. Overall successful cannulation and ERCP adverse events also were studied. RESULTS: A total of 710 patients were enrolled in the study. The primary wire-guided biliary cannulation rate was similar in 0.025-inch and 0.035-inch wire groups (80.7% vs 80.3%; P = .90). The rate of PEP between the 0.025-inch and the 0.035-inch wire groups did not differ significantly (7.8% vs 9.3%; P = .51). No differences were noted in secondary outcomes. CONCLUSION: Similar rates of successful cannulation and PEP were demonstrated in the use of 0.025-inch and 0.035-inch guidewires. (Clinical trial registration number: NCT01408264.).
Authors: Muhammad Aziz; Amna Iqbal; Zohaib Ahmed; Saad Saleem; Wade Lee-Smith; Hemant Goyal; Faisal Kamal; Yaseen Alastal; Ali Nawras; Douglas G Adler Journal: Endosc Int Open Date: 2022-07-15