Department of Surgery and Department of Research and Development, Central Hospital, Region Kronoberg, Växjö, Sweden.
Department of Clinical Sciences Lund, Lund University and Department of Surgery, Skåne University Hospital, Lund, Sweden.
Scand J Surg. 2022 Apr-Jun;111(2):14574969221102284. doi: 10.1177/14574969221102284.
The most common way of closing the cystic duct in laparoscopic cholecystectomy is by using metal clips (>80%). Nevertheless, bile leakage occurs in 0.4%-2.0% of cases, and thus causes significant morbidity. However, the optimal number of clips needed to avoid bile leakage has not been determined. The primary aim of this study was to evaluate bile leakage and post-procedural adverse events after laparoscopic cholecystectomy concerning whether two or three clips were used to seal the cystic duct.
Using a retrospective observational design, we gathered data from the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (ERCP) (GallRiks). From 2006 until 2019, 124,818 patients were eligible for inclusion. These were nested to cohorts of 75,322 (60.3%) for uncomplicated gallstone disease and 49,496 (39.7%) with complicated gallstone disease. The cohorts were grouped by the number (i.e. two or three) of metal clips applied to the proximal cystic duct. The main outcome was 30-day bile leakage and post-procedural adverse events.
No significant differences surfaced in the rate of bile leakage (0.8% vs 0.8%; = .87) or post-procedural adverse events (three clips, 5.7% vs two clips, 5.4%; = .16) for uncomplicated gallstone disease. However, for complicated disease, bile leakage (1.4% vs 1.0%; < .001) and post-procedural adverse events (10.2% vs 8.6%; < .001) significantly increased when the cystic duct was sealed with three clips compared with two.
Because no differences in the rates of bile leakage or adverse events emerged in uncomplicated gallstone disease when a third clip was applied, a third clip for additional safety is not recommended in such cases. On the contrary, bile leakage and adverse events increased when a third clip was used in patients with complicated gallstone disease. This finding probably indicates a more difficult cholecystectomy rather than being caused by the third clip itself.
腹腔镜胆囊切除术（LC）中最常用的方法是使用金属夹（>80%）来关闭胆囊管。然而，仍有 0.4%-2.0%的病例发生胆漏，从而导致显著的发病率。但是，尚未确定避免胆漏所需的最佳夹闭数量。本研究的主要目的是评估 LC 中使用两个或三个夹子来封闭胆囊管后胆漏和术后不良事件。
使用回顾性观察设计，我们从瑞典胆囊结石手术和内镜逆行胰胆管造影（ERCP）（GallRiks）登记处收集数据。从 2006 年到 2019 年，共有 124818 名患者符合纳入条件。将这些患者嵌套到两组队列中，75322 例（60.3%）为单纯胆囊结石病，49496 例（39.7%）为复杂胆囊结石病。这些队列按应用于近端胆囊管的金属夹数量（即两个或三个）进行分组。主要结局为 30 天胆漏和术后不良事件。
单纯胆囊结石病患者中，胆漏发生率（0.8% vs 0.8%； =.87）或术后不良事件（三个夹子，5.7% vs 两个夹子，5.4%； =.16）无显著差异。然而，对于复杂疾病，当使用三个夹子封闭胆囊管时，胆漏（1.4% vs 1.0%； <.001）和术后不良事件（10.2% vs 8.6%； <.001）显著增加。
在单纯胆囊结石病中，当使用第三个夹子时，胆漏或不良事件的发生率没有差异，因此不建议在这种情况下使用第三个夹子来增加额外的安全性。相反，在复杂胆囊结石病患者中使用第三个夹子时，胆漏和不良事件增加。这一发现可能表明胆囊切除术更困难，而不是由第三个夹子本身引起的。
