Aggressive hydration with lactated Ringer’s solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial
Introduction Endoscopic retrograde cholangiopancreatography (ERCP) plays an indispensable role in treating pancreato-biliary diseases but carries a risk of post-ERCP pancreatitis (PEP). Despite advances in the prevention strategies, prevention of PEP remains imperfect, necessitating more refined hyd...
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BMJ Publishing Group
2024-07-01
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| author | In Rae Cho Sang Hyub Lee Jin Ho Choi Joo Kyung Park Gunn Huh Woo Hyun Paik Do Hyun Park |
| author_facet | In Rae Cho Sang Hyub Lee Jin Ho Choi Joo Kyung Park Gunn Huh Woo Hyun Paik Do Hyun Park |
| author_sort | In Rae Cho |
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| description | Introduction Endoscopic retrograde cholangiopancreatography (ERCP) plays an indispensable role in treating pancreato-biliary diseases but carries a risk of post-ERCP pancreatitis (PEP). Despite advances in the prevention strategies, prevention of PEP remains imperfect, necessitating more refined hydration methods. This study investigates the effectiveness of lactated Ringer’s solution versus plasma solution in preventing PEP.Method and analysis This multicentre, double-blind, randomised controlled trial, will be initiated by the investigator-sponsor, and conducted in three tertiary centres in South Korea. The aim of this study is to assess the effectiveness of hydration in preventing PEP in patients with naïve papillae. It will target patients with naïve papillae, focusing on those at medium to high risk of PEP. Patients aged ≤18 years and those with serious comorbidities, acute/chronic pancreatitis and various other medical conditions will be excluded. Eligible participants will be randomly assigned into two arms in equal numbers: (1) PEP prevention using lactated Ringer’s solution and (2) PEP prevention using plasma solution. The primary outcome of this study will be the occurrence of PEP, and secondary outcomes will be additional risk factors and potential adverse events related to ERCP. With a total enrolment of 844 patients, the study will be able to detect significant differences between the intervention arms.Ethics and dissemination Ethical approval is obtained from each institution (Asan Medical Centre, 2023-0382; Seoul National University Hospital, H-2302-05-1404; Samsung Medical Centre, SMC 2023-02-001-009). All participants provided informed consent following clear explanation of the study procedures. The results of the study will be disseminated in peer-reviewed journals and research conferences.Trial registration number NCT05832047.Protocol version Ver 4.1 (2023). |
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| language | English |
| publishDate | 2024-07-01 |
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| spelling | doaj-art-a29fb1e27f4b420484aa1ed8770a201c2025-08-20T02:13:03ZengBMJ Publishing GroupBMJ Open2044-60552024-07-0114710.1136/bmjopen-2024-084052Aggressive hydration with lactated Ringer’s solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trialIn Rae Cho0Sang Hyub Lee1Jin Ho Choi2Joo Kyung Park3Gunn Huh4Woo Hyun Paik5Do Hyun Park6Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Jongno-gu, Seoul, Korea (the Republic of)Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Jongno-gu, Seoul, Korea (the Republic of)Department of Internal Medicine, Samsung Medical Center, Gangnam-gu, Seoul, Korea (the Republic of)Division of Gastroenterology, Deparent of Medicine, Samsung Medical Center, Seoul, Korea (the Republic of)Department of Gastroenterology, Asan Medical Center, Songpa-gu, Seoul, Korea (the Republic of)Division of Gastroenterology, Department of Internal Medicine, Seoul National University Hospital, Seoul, KoreaDepartment of Internal Medicine, Division of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Songpa-gu, Seoul, Korea (the Republic of)Introduction Endoscopic retrograde cholangiopancreatography (ERCP) plays an indispensable role in treating pancreato-biliary diseases but carries a risk of post-ERCP pancreatitis (PEP). Despite advances in the prevention strategies, prevention of PEP remains imperfect, necessitating more refined hydration methods. This study investigates the effectiveness of lactated Ringer’s solution versus plasma solution in preventing PEP.Method and analysis This multicentre, double-blind, randomised controlled trial, will be initiated by the investigator-sponsor, and conducted in three tertiary centres in South Korea. The aim of this study is to assess the effectiveness of hydration in preventing PEP in patients with naïve papillae. It will target patients with naïve papillae, focusing on those at medium to high risk of PEP. Patients aged ≤18 years and those with serious comorbidities, acute/chronic pancreatitis and various other medical conditions will be excluded. Eligible participants will be randomly assigned into two arms in equal numbers: (1) PEP prevention using lactated Ringer’s solution and (2) PEP prevention using plasma solution. The primary outcome of this study will be the occurrence of PEP, and secondary outcomes will be additional risk factors and potential adverse events related to ERCP. With a total enrolment of 844 patients, the study will be able to detect significant differences between the intervention arms.Ethics and dissemination Ethical approval is obtained from each institution (Asan Medical Centre, 2023-0382; Seoul National University Hospital, H-2302-05-1404; Samsung Medical Centre, SMC 2023-02-001-009). All participants provided informed consent following clear explanation of the study procedures. The results of the study will be disseminated in peer-reviewed journals and research conferences.Trial registration number NCT05832047.Protocol version Ver 4.1 (2023).https://bmjopen.bmj.com/content/14/7/e084052.full |
| spellingShingle | In Rae Cho Sang Hyub Lee Jin Ho Choi Joo Kyung Park Gunn Huh Woo Hyun Paik Do Hyun Park Aggressive hydration with lactated Ringer’s solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial BMJ Open |
| title | Aggressive hydration with lactated Ringer’s solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial |
| title_full | Aggressive hydration with lactated Ringer’s solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial |
| title_fullStr | Aggressive hydration with lactated Ringer’s solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial |
| title_full_unstemmed | Aggressive hydration with lactated Ringer’s solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial |
| title_short | Aggressive hydration with lactated Ringer’s solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial |
| title_sort | aggressive hydration with lactated ringer s solution versus plasma solution for the prevention of post endoscopic retrograde cholangiopancreatography ercp pancreatitis alps study protocol for a multicentre double blind randomised controlled trial |
| url | https://bmjopen.bmj.com/content/14/7/e084052.full |
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