Langenbeck's Archives of Surgery ( IF 2.1 ) Pub Date : 2023-12-29 , DOI: 10.1007/s00423-023-03212-9 Anubhav Harshit Kumar 1 , Viniyendra Pamecha 1 , Nilesh Sadashiv Patil 1 , Nihar Mohapatra 1 , Ragini Kilambi 1 , Piyush Kumar Sinha 1
|
Background
Post-operative hyperamylasemia (POH) following pancreatoduodenectomy (PD) may play a key role in pathogenesis of post-operative pancreatic fistula (POPF). Aim of the current study was to evaluate efficacy of perioperative administration of indomethacin in preventing POH.
Methods
Single-center, double-blind, randomized controlled trial (RCT) conducted on consecutive patients undergoing PD. Patients received either 100 mg of indomethacin per-rectally at induction of anesthesia or standard care. Primary endpoint was incidence of POH in the two arms. POH was defined as postoperative day (POD) 1 serum amylase (S. amylase) levels greater than the upper limit of normal.
Results
After exclusion 44 patients were randomized. The two arms were comparable for preoperative and intraoperative parameters. POH was noted in 20/44 (45.5%) with significantly lower incidence of POH (60.9% vs. 28.6%, p = 0.032) in intervention arm (IA). Median S. amylase, POD 1, 3, and 5 drain amylase, and incidence of clinically relevant POPF (CR-POPF) were lower in IA but failed to reach statistical significance (30.4% vs. 14.3%, p = 0.18). The severity of delayed gastric emptying (DGE) was significantly lower in the IA (grade B/C DGE 23.8% vs. 47.8%, p = 0.023). Evaluation of risk factors for POH showed IA to confer an independent protective effect and increased risk with soft pancreas.
Conclusion
Perioperative per-rectal indomethacin administration is effective in decreasing the incidence of POH following pancreatoduodenectomy.
中文翻译：
直肠吲哚美辛预防胰十二指肠切除术后高淀粉酶血症的功效：一项随机对照试验
背景
胰十二指肠切除术（PD）术后高淀粉酶血症（POH）可能在术后胰瘘（POPF）的发病机制中发挥关键作用。本研究的目的是评估围手术期给予吲哚美辛预防 POH 的效果。
方法
对连续接受 PD 的患者进行的单中心、双盲、随机对照试验 (RCT)。患者在麻醉诱导或标准护理时经直肠接受 100 毫克吲哚美辛。主要终点是两组 POH 的发生率。 POH被定义为术后第1天（POD）血清淀粉酶（S.淀粉酶）水平高于正常上限。
结果
排除后，44 名患者被随机分组。两组术前和术中参数具有可比性。干预组 (IA) 中 POH 的发生率为 20/44 (45.5%)，POH 发生率显着较低（60.9% 对比 28.6%， p = 0.032）。 IA 中 S. 淀粉酶、POD 1、3 和 5 排出淀粉酶以及临床相关 POPF (CR-POPF) 发生率的中位数较低，但未能达到统计学显着性（30.4% vs. 14.3%， p = 0.18）。 IA 中胃排空延迟 (DGE) 的严重程度显着较低（B/C 级 DGE 为 23.8% 对比 47.8%， p = 0.023）。对 POH 危险因素的评估表明，IA 具有独立的保护作用，并增加了软胰腺的风险。
结论
围手术期经直肠吲哚美辛给药可有效降低胰十二指肠切除术后 POH 的发生率。
京公网安备 11010802027423号