Johansson Jan, Oberg Stefan, Wenner Jörgen, Zilling Thomas, Johnsson Folke, von Holstein Christer Staël, Walther Bruno
Department of Surgery, Lund University Hospital, S-22185 Lund, Sweden.
Ann Surg. 2009 Nov;250(5):667-73. doi: 10.1097/SLA.0b013e3181bcb139.
The primary aim of this study was to evaluate if the use of proton pump inhibitors (PPIs) reduced the prevalence of benign anastomotic strictures after uncomplicated esophagectomies with gastric tube reconstruction and circular stapled anastomoses.
Benign anastomotic strictures are associated with anastomotic leaks or conduit ischemia. Also patients without those complications develop benign anastomotic strictures. We hypothesize that patients without postoperative anastomotic complications may develop benign anastomotic strictures due to exposure of acid gastric tube contents to the anastomotic area, and that the formation of such strictures may be reduced by prophylactic use of PPIs.
Eighty patients without preoperative chemo- or radiotherapy, without clinical or radiological signs of anastomotic leaks were included in this clinical trial. The patients were randomized to b.i.d. PPIs or no treatment for 1 year. Benign anastomotic strictures were defined as anastomotic narrowing not allowing a standard diagnostic endoscope to pass without dilatation. The study was registered in the EudraCT database (2009-009997-28) for clinical trials.
: Seventy-nine patients were evaluated. Benign anastomotic strictures developed in 5/39 (13%) patients in the PPI group and in 18/40 (45%) in the control group (RR 5.6, 95% CI: 2.0-15.9, P = 0.001). The use of a narrower 25 mm cartridge as compared to a wider 28 or 31 mm cartridge significantly increased stricture formations (RR 2.9, 95% CI: 1.1-7.6, P = 0.025).
Prophylactic PPI treatment reduced the prevalence of benign anastomotic strictures following esophagectomy with gastric tube reconstruction and circular stapled anastomoses. Larger sized circular staple cartridges additionally reduced the stricture prevalence.
本研究的主要目的是评估质子泵抑制剂（PPI）的使用是否能降低在采用胃管重建和圆形吻合器吻合的无并发症食管切除术后良性吻合口狭窄的发生率。
良性吻合口狭窄与吻合口漏或管道缺血相关。而且没有这些并发症的患者也会出现良性吻合口狭窄。我们推测，没有术后吻合口并发症的患者可能由于胃酸反流至胃管内容物暴露于吻合口区域而出现良性吻合口狭窄，并且预防性使用PPI可能会减少此类狭窄的形成。
80例无术前化疗或放疗、无吻合口漏临床或影像学征象的患者纳入本临床试验。患者被随机分为每日两次服用PPI组或不治疗组，为期1年。良性吻合口狭窄定义为吻合口狭窄，不进行扩张则标准诊断性内窥镜无法通过。该研究已在欧洲临床试验数据库（EudraCT，2009 - 009997 - 28）中注册。
79例患者接受评估。PPI组39例患者中有5例（13%）发生良性吻合口狭窄，对照组40例患者中有18例（45%）发生（相对危险度5.6，95%置信区间：2.0 - 15.9，P = 0.001）。与使用更宽的28或31mm钉仓相比，使用更窄的25mm钉仓显著增加了狭窄的形成（相对危险度2.9，95%置信区间：1.1 - 7.6，P = 0.025）。
预防性PPI治疗降低了采用胃管重建和圆形吻合器吻合的食管切除术后良性吻合口狭窄的发生率。更大尺寸的圆形吻合器钉仓可进一步降低狭窄发生率。
