{"title":"大容量乳酸林格氏液加人白蛋白与标准容量输注预防内镜后逆行胆管胰造影术胰腺炎：随机临床试验","authors":"Ekaphan Shatsnimitkul, Issaree Laopeamthong, Amarit Tansawet, Suphakarn Techapongsatorn, Wisit Kasetsermwiriya, Poramet Leungon, Pakkapol Sukhvibul","doi":"10.1093/bjsopen/zrae149","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Adverse events after endoscopic retrograde cholangiopancreatography (ERCP) are rare, and post-ERCP pancreatitis is a serious adverse event. This study aimed to determine the role of aggressive intravenous hydration with lactated Ringer's solution at a specific volume with 20% human albumin before ERCP in reducing the incidence of post-ERCP pancreatitis.</p><p><strong>Methods: </strong>This study was a single-centre randomized clinical trial. The participants were randomly assigned to two groups: those who received aggressive intravenous hydration with 20% human albumin and lactated Ringer's solution (intervention group), and those who received standard-volume intravenous hydration with lactated Ringer's solution (control group). The primary endpoint was post-ERCP pancreatitis. Participants and outcome assessors were blinded to treatment allocation. Comparison was performed using the chi-square, the Fisher's exact, the Student's t, or the Mann-Whitney U tests, where appropriate.</p><p><strong>Results: </strong>Of 300 randomized participants, 149 and 144 participants from the intervention and control group were included in the analysis. There was no significant difference in the post-ERCP pancreatitis rate (n = 10; 6.7% versus n = 9; 6.3%, P = 0.873) between the intervention and control groups. High-risk procedures (that is pancreatic duct wiring, pancreatic duct injection, precut sphincterotomy, and balloon dilation of the ampulla) were significantly associated with post-ERCP pancreatitis compared with low-risk procedures (n = 15; 15% versus n = 4; 2.1%, P < 0.001). In the high-risk procedures population, the intervention and control groups had increased post-ERCP pancreatitis rates (P = 0.716). Two participants in each group developed pulmonary congestion.</p><p><strong>Conclusion: </strong>Aggressive peri-ERCP intravenous hydration with lactated Ringer's solution combined with 50 ml of 20% human albumin did not prevent post-ERCP pancreatitis. None of the subgroups presented with prophylactic effects.</p><p><strong>Trial registration: </strong>Thai Clinical Trials Registry (TCTR20240405003).</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 1","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749547/pdf/","citationCount":"0","resultStr":"{\"title\":\"High-volume lactated Ringer's solution with human albumin versus standard-volume infusion as a prophylactic treatment for post-endoscopic retrograde cholangiopancreatography pancreatitis: randomized clinical trial.\",\"authors\":\"Ekaphan Shatsnimitkul, Issaree Laopeamthong, Amarit Tansawet, Suphakarn Techapongsatorn, Wisit Kasetsermwiriya, Poramet Leungon, Pakkapol Sukhvibul\",\"doi\":\"10.1093/bjsopen/zrae149\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Adverse events after endoscopic retrograde cholangiopancreatography (ERCP) are rare, and post-ERCP pancreatitis is a serious adverse event. This study aimed to determine the role of aggressive intravenous hydration with lactated Ringer's solution at a specific volume with 20% human albumin before ERCP in reducing the incidence of post-ERCP pancreatitis.</p><p><strong>Methods: </strong>This study was a single-centre randomized clinical trial. The participants were randomly assigned to two groups: those who received aggressive intravenous hydration with 20% human albumin and lactated Ringer's solution (intervention group), and those who received standard-volume intravenous hydration with lactated Ringer's solution (control group). The primary endpoint was post-ERCP pancreatitis. Participants and outcome assessors were blinded to treatment allocation. Comparison was performed using the chi-square, the Fisher's exact, the Student's t, or the Mann-Whitney U tests, where appropriate.</p><p><strong>Results: </strong>Of 300 randomized participants, 149 and 144 participants from the intervention and control group were included in the analysis. There was no significant difference in the post-ERCP pancreatitis rate (n = 10; 6.7% versus n = 9; 6.3%, P = 0.873) between the intervention and control groups. High-risk procedures (that is pancreatic duct wiring, pancreatic duct injection, precut sphincterotomy, and balloon dilation of the ampulla) were significantly associated with post-ERCP pancreatitis compared with low-risk procedures (n = 15; 15% versus n = 4; 2.1%, P < 0.001). In the high-risk procedures population, the intervention and control groups had increased post-ERCP pancreatitis rates (P = 0.716). Two participants in each group developed pulmonary congestion.</p><p><strong>Conclusion: </strong>Aggressive peri-ERCP intravenous hydration with lactated Ringer's solution combined with 50 ml of 20% human albumin did not prevent post-ERCP pancreatitis. None of the subgroups presented with prophylactic effects.</p><p><strong>Trial registration: </strong>Thai Clinical Trials Registry (TCTR20240405003).</p>\",\"PeriodicalId\":9028,\"journal\":{\"name\":\"BJS Open\",\"volume\":\"9 1\",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2024-12-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749547/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BJS Open\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/bjsopen/zrae149\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BJS Open","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/bjsopen/zrae149","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
摘要
背景：内镜逆行胰胆管造影（ERCP）后的不良事件是罕见的，ERCP后胰腺炎是一个严重的不良事件。本研究旨在确定ERCP前以20%人白蛋白的特定体积乳酸林格氏液积极静脉补水在减少ERCP后胰腺炎发生率中的作用。方法：本研究为单中心随机临床试验。参与者被随机分为两组：一组接受20%人白蛋白加乳酸林格液的积极静脉补水（干预组），另一组接受标准体积乳酸林格液静脉补水（对照组）。主要终点为ercp后胰腺炎。参与者和结果评估者对治疗分配不知情。在适当的情况下，使用卡方检验、Fisher精确检验、Student t检验或Mann-Whitney U检验进行比较。结果：300名随机受试者中，干预组149人，对照组144人纳入分析。ercp后胰腺炎发生率无显著差异(n = 10；6.7% vs n = 9；6.3%, P = 0.873)。与低风险手术相比，高风险手术（即胰管连接、胰管注射、切开前括约肌切开术和壶腹球囊扩张）与ercp后胰腺炎显著相关(n = 15；15% vs n = 4；2.1%, p < 0.001)。在高危手术人群中，干预组和对照组ercp后胰腺炎发生率增高（P = 0.716）。每组两名参与者出现肺充血。结论：ercp围期积极静脉补液乳酸林格氏液联合50ml 20%人白蛋白不能预防ercp后胰腺炎。没有一个亚组表现出预防作用。试验注册：泰国临床试验注册中心（TCTR20240405003）。
High-volume lactated Ringer's solution with human albumin versus standard-volume infusion as a prophylactic treatment for post-endoscopic retrograde cholangiopancreatography pancreatitis: randomized clinical trial.
Background: Adverse events after endoscopic retrograde cholangiopancreatography (ERCP) are rare, and post-ERCP pancreatitis is a serious adverse event. This study aimed to determine the role of aggressive intravenous hydration with lactated Ringer's solution at a specific volume with 20% human albumin before ERCP in reducing the incidence of post-ERCP pancreatitis.
Methods: This study was a single-centre randomized clinical trial. The participants were randomly assigned to two groups: those who received aggressive intravenous hydration with 20% human albumin and lactated Ringer's solution (intervention group), and those who received standard-volume intravenous hydration with lactated Ringer's solution (control group). The primary endpoint was post-ERCP pancreatitis. Participants and outcome assessors were blinded to treatment allocation. Comparison was performed using the chi-square, the Fisher's exact, the Student's t, or the Mann-Whitney U tests, where appropriate.
Results: Of 300 randomized participants, 149 and 144 participants from the intervention and control group were included in the analysis. There was no significant difference in the post-ERCP pancreatitis rate (n = 10; 6.7% versus n = 9; 6.3%, P = 0.873) between the intervention and control groups. High-risk procedures (that is pancreatic duct wiring, pancreatic duct injection, precut sphincterotomy, and balloon dilation of the ampulla) were significantly associated with post-ERCP pancreatitis compared with low-risk procedures (n = 15; 15% versus n = 4; 2.1%, P < 0.001). In the high-risk procedures population, the intervention and control groups had increased post-ERCP pancreatitis rates (P = 0.716). Two participants in each group developed pulmonary congestion.
Conclusion: Aggressive peri-ERCP intravenous hydration with lactated Ringer's solution combined with 50 ml of 20% human albumin did not prevent post-ERCP pancreatitis. None of the subgroups presented with prophylactic effects.
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