胰十二指肠切除术后胰管黏膜对套入式胰肠吻合术随机临床试验。
Randomized clinical trial of duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy.
机构信息
Department of Gastroenterological Surgery, Aichi Cancer Centre Hospital, Nagoya, Japan.
Division of Molecular Medicine, Aichi Cancer Centre Research Institute, Nagoya, Japan.
出版信息
Br J Surg. 2018 Jan;105(1):48-57. doi: 10.1002/bjs.10727.
BACKGROUND
The postoperative pancreatic fistula (POPF) rate for duct-to-mucosa and invagination anastomosis after pancreatoduodenectomy is still debated. The aim of this RCT was to investigate the POPF rate for duct-to-mucosa versus invagination pancreaticojejunostomy.
METHODS
Patients were stratified by pancreatic texture and diameter of the main pancreatic duct and randomized to the duct-to-mucosa or invagination group. The primary endpoint was the rate of clinically relevant POPF (defined as grade B or C). Secondary endpoints were suture material cost for pancreaticojejunostomy, drain insertion duration and duration of postoperative hospital stay.
RESULTS
Some 120 patients undergoing pancreatoduodenectomy were included following consent. Clinically relevant POPF developed in six of 59 patients (10 per cent) in the invagination group and in 14 of 61 patients (23 per cent) in the duct-to-mucosa group (P = 0·077). Duration of drain insertion (6 versus 7 days respectively; P = 0·027) and postoperative hospital stay (19 versus 24 days; P = 0·015) were shorter in the invagination group. Subgroup analysis for 61 patients with a soft pancreas revealed a lower rate of clinically relevant POPF in the invagination group (10 per cent versus 42 per cent in the duct-to-mucosa group; P = 0·010). Among 20 patients with a clinically relevant POPF, the six patients in the invagination group had a shorter duration of drain insertion (38·5 days versus 49 days for 14 patients in the duct-to-mucosa group; P = 0·028) and postoperative hospital stay (42 versus 54·5 days respectively; P = 0·028).
CONCLUSION
This study did not demonstrate a superiority of invagination over duct-to-mucosa pancreaticojejunostomy in the risk of POPF. However, in high-risk patients with a soft pancreas, invagination may reduce the risk of clinically relevant POPF compared with duct-to-mucosa. Registration number: UMIN000005890 (http://www.umin.ac.jp).
背景
胰十二指肠切除术后采用黏膜对黏膜吻合与套入式吻合的胰瘘（POPF）发生率仍存在争议。本 RCT 的目的是比较胰肠黏膜吻合与套入式吻合预防胰瘘的效果。
方法
患者根据胰腺质地和主胰管直径进行分层，并随机分为黏膜对黏膜组或套入式组。主要终点为临床相关 POPF（定义为 B 级或 C 级）的发生率。次要终点为胰肠吻合的缝线材料成本、引流管放置时间和术后住院时间。
结果
同意后共纳入 120 例行胰十二指肠切除术的患者。在套入式组的 59 例患者中有 6 例（10%）和黏膜对黏膜组的 61 例患者中有 14 例（23%）发生了临床相关的 POPF（P=0·077）。套入式组引流管放置时间（分别为 6 天和 7 天；P=0·027）和术后住院时间（分别为 19 天和 24 天；P=0·015）较短。在胰腺质地柔软的 61 例患者的亚组分析中，套入式组的临床相关 POPF 发生率较低（10%比黏膜对黏膜组的 42%；P=0·010）。在 20 例临床相关 POPF 患者中，套入式组的 6 例患者引流管放置时间（42·5 天比黏膜对黏膜组的 49 天；P=0·028）和术后住院时间（42 天比黏膜对黏膜组的 54·5 天；P=0·028）较短。
结论
本研究未证明套入式与黏膜对黏膜吻合预防 POPF 的风险存在优势。然而，在胰腺质地柔软的高危患者中，与黏膜对黏膜吻合相比，套入式可能降低临床相关 POPF 的风险。注册号：UMIN000005890（http://www.umin.ac.jp）。
Zotero 插件