{"title":"围手术期氢化可的松或吲哚美辛能改善胰十二指肠切除术的疗效吗？三臂随机安慰剂对照试验。","authors":"Kislay Kant, Zeeshan Ahmed, Rohit Dama, Monish Karunakaran, Prateek Arora, Pradeep Rebala, Guduru Venkat Rao","doi":"10.14701/ahbps.24-021","DOIUrl":null,"url":null,"abstract":"<p><strong>Backgrounds/aims: </strong>This trial evaluated whether anti-inflammatory agents hydrocortisone (H) and indomethacin (I) could reduce major complications after pancreatoduodenectomy (PD).</p><p><strong>Methods: </strong>Between June 2018 and June 2020, 105 patients undergoing PD with > 40% of acini on the intraoperative frozen section were randomized into three groups (35 patients per group): 1) intravenous H 100 mg 8 hourly, 2) rectal I suppository 100 mg 12 hourly, and 3) placebo (P) from postoperative day (POD) 0-2. Participants, investigators, and outcome assessors were blinded. The primary outcome was major complications (Clavien-Dindo grades 3-5). Secondary outcomes were overall complications (Clavien-Dindo grades 1-5), Clinically relevant postoperative pancreatic fistula (CR-POPF), delayed gastric emptying (DGE), postpancreatectomy hemorrhage (PPH), surgical site infections (SSI), length of stay, POD-3 serum amylase, readmission rate, and mortality.</p><p><strong>Results: </strong>Major complications were comparable (8.6%, 5.7%, and 8.6% in groups H, I, and P, respectively). However, overall complications were significantly lower in group H than in group P (45.7% vs. 80.0%, <i>p</i> = 0.006). CR-POPF (14.3% vs. 25.7%, <i>p</i> = 0.371), PPH (8.6% vs. 14.3%, <i>p</i> = 0.710), DGE (8.6% vs. 22.9%, <i>p</i> = 0.188), and SSI (14.3% vs. 25.7%, <i>p</i> = 0.371) were comparable between groups H and P. Major complications and overall complications in group I were 5.7% and 60.0%, respectively, which were comparable to those in groups P and H. CR-POPF rates in groups H, I, and P were 14.3%, 17.1%, and 25.7%, respectively, which was comparable.</p><p><strong>Conclusions: </strong>H and I did not decrease major complications in PD.</p>","PeriodicalId":72220,"journal":{"name":"Annals of hepato-biliary-pancreatic surgery","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11341883/pdf/","citationCount":"0","resultStr":"{\"title\":\"Does perioperative hydrocortisone or indomethacin improve pancreatoduodenectomy outcomes? A triple arm, randomized placebo-controlled trial.\",\"authors\":\"Kislay Kant, Zeeshan Ahmed, Rohit Dama, Monish Karunakaran, Prateek Arora, Pradeep Rebala, Guduru Venkat Rao\",\"doi\":\"10.14701/ahbps.24-021\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Backgrounds/aims: </strong>This trial evaluated whether anti-inflammatory agents hydrocortisone (H) and indomethacin (I) could reduce major complications after pancreatoduodenectomy (PD).</p><p><strong>Methods: </strong>Between June 2018 and June 2020, 105 patients undergoing PD with > 40% of acini on the intraoperative frozen section were randomized into three groups (35 patients per group): 1) intravenous H 100 mg 8 hourly, 2) rectal I suppository 100 mg 12 hourly, and 3) placebo (P) from postoperative day (POD) 0-2. Participants, investigators, and outcome assessors were blinded. The primary outcome was major complications (Clavien-Dindo grades 3-5). Secondary outcomes were overall complications (Clavien-Dindo grades 1-5), Clinically relevant postoperative pancreatic fistula (CR-POPF), delayed gastric emptying (DGE), postpancreatectomy hemorrhage (PPH), surgical site infections (SSI), length of stay, POD-3 serum amylase, readmission rate, and mortality.</p><p><strong>Results: </strong>Major complications were comparable (8.6%, 5.7%, and 8.6% in groups H, I, and P, respectively). However, overall complications were significantly lower in group H than in group P (45.7% vs. 80.0%, <i>p</i> = 0.006). CR-POPF (14.3% vs. 25.7%, <i>p</i> = 0.371), PPH (8.6% vs. 14.3%, <i>p</i> = 0.710), DGE (8.6% vs. 22.9%, <i>p</i> = 0.188), and SSI (14.3% vs. 25.7%, <i>p</i> = 0.371) were comparable between groups H and P. Major complications and overall complications in group I were 5.7% and 60.0%, respectively, which were comparable to those in groups P and H. CR-POPF rates in groups H, I, and P were 14.3%, 17.1%, and 25.7%, respectively, which was comparable.</p><p><strong>Conclusions: </strong>H and I did not decrease major complications in PD.</p>\",\"PeriodicalId\":72220,\"journal\":{\"name\":\"Annals of hepato-biliary-pancreatic surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2024-08-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11341883/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of hepato-biliary-pancreatic surgery\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.14701/ahbps.24-021\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/4/29 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of hepato-biliary-pancreatic surgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14701/ahbps.24-021","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/4/29 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景/目的：该试验评估了抗炎药氢化可的松（H）和吲哚美辛（I）能否减少胰十二指肠切除术（PD）后的主要并发症：2018年6月至2020年6月期间，105名接受胰十二指肠切除术且术中冰冻切片显示尖头>40%的患者被随机分为三组（每组35名患者）：1）静脉注射 H 100 毫克，每小时 8 次；2）直肠 I 栓剂 100 毫克，每小时 12 次；3）安慰剂（P），从术后第 0-2 天（POD）开始。参与者、研究人员和结果评估人员均为盲人。主要结果是主要并发症（Clavien-Dindo 3-5 级）。次要结果是总体并发症（Clavien-Dindo 1-5级）、临床相关术后胰瘘（CR-POPF）、胃排空延迟（DGE）、胰腺切除术后出血（PPH）、手术部位感染（SSI）、住院时间、POD-3血清淀粉酶、再入院率和死亡率：主要并发症的发生率相当（H、I 和 P 组分别为 8.6%、5.7% 和 8.6%）。然而，H 组的总体并发症明显低于 P 组（45.7% 对 80.0%，P = 0.006）。H组和P组的CR-POPF（14.3% vs. 25.7%，P = 0.371）、PPH（8.6% vs. 14.3%，P = 0.710）、DGE（8.6% vs. 22.9%，P = 0.188）和SSI（14.3% vs. 25.7%，P = 0.371）相当。H组、I组和P组的CR-POPF率分别为14.3%、17.1%和25.7%，具有可比性：结论：H组和I组并没有减少腹腔镜手术的主要并发症。
Does perioperative hydrocortisone or indomethacin improve pancreatoduodenectomy outcomes? A triple arm, randomized placebo-controlled trial.
Backgrounds/aims: This trial evaluated whether anti-inflammatory agents hydrocortisone (H) and indomethacin (I) could reduce major complications after pancreatoduodenectomy (PD).
Methods: Between June 2018 and June 2020, 105 patients undergoing PD with > 40% of acini on the intraoperative frozen section were randomized into three groups (35 patients per group): 1) intravenous H 100 mg 8 hourly, 2) rectal I suppository 100 mg 12 hourly, and 3) placebo (P) from postoperative day (POD) 0-2. Participants, investigators, and outcome assessors were blinded. The primary outcome was major complications (Clavien-Dindo grades 3-5). Secondary outcomes were overall complications (Clavien-Dindo grades 1-5), Clinically relevant postoperative pancreatic fistula (CR-POPF), delayed gastric emptying (DGE), postpancreatectomy hemorrhage (PPH), surgical site infections (SSI), length of stay, POD-3 serum amylase, readmission rate, and mortality.
Results: Major complications were comparable (8.6%, 5.7%, and 8.6% in groups H, I, and P, respectively). However, overall complications were significantly lower in group H than in group P (45.7% vs. 80.0%, p = 0.006). CR-POPF (14.3% vs. 25.7%, p = 0.371), PPH (8.6% vs. 14.3%, p = 0.710), DGE (8.6% vs. 22.9%, p = 0.188), and SSI (14.3% vs. 25.7%, p = 0.371) were comparable between groups H and P. Major complications and overall complications in group I were 5.7% and 60.0%, respectively, which were comparable to those in groups P and H. CR-POPF rates in groups H, I, and P were 14.3%, 17.1%, and 25.7%, respectively, which was comparable.
Conclusions: H and I did not decrease major complications in PD.
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