Haraldsplass Deaconal Hospital, University of Bergen, Bergen, Norway.
Dig Surg. 2011;28(4):270-6. doi: 10.1159/000329464. Epub 2011 Jul 9.
BACKGROUND/AIMS: Cholecystectomy is considered the treatment of choice for symptomatic gallstone disease. Some patients abstain from surgery and provide the opportunity to study the natural history of cholelithiasis. The aim of the present study was to examine the feasibility and safety of observation after extended long-term follow-up in a randomized controlled trial.
A total of 137 patients (40.5% of those assessed) were randomized to observation or cholecystectomy and followed up for 14 years. The prevalence of symptomatic events or major complications after treatment was the primary end point. A secondary end point was completion of randomized treatment.
There were no differences in outcome between the observation group and the surgical group (p = 0.298). Virtually no cholecystectomy was performed after 5 years of follow-up, and no clear escalation in the severity of the disease was observed. A total of 50.7% of patients from the observation group and 88.2% from the surgical group underwent surgery. The group randomized to surgery completed their designated treatment significantly more often (p < 0.001), especially among patients younger than 70 years of age (p = 0.005).
Cholecystectomy was the preferred treatment after extended long-term follow-up, but conservative management for symptomatic gallstone disease is an alternative to surgery in the elderly.
背景/目的：胆囊切除术被认为是治疗有症状的胆囊疾病的首选方法。有些患者选择不手术，并为研究胆石病的自然病程提供了机会。本研究旨在在一项随机对照试验中检查长期随访后观察的可行性和安全性。
共有 137 名患者（评估患者的 40.5%）被随机分配到观察组或胆囊切除术组，并随访 14 年。治疗后出现症状性事件或主要并发症的发生率为主要终点。次要终点是完成随机治疗。
观察组和手术组之间的结果无差异（p = 0.298）。几乎没有在随访 5 年后进行胆囊切除术，也没有观察到疾病严重程度的明显加重。观察组和手术组分别有 50.7%和 88.2%的患者接受了手术。随机接受手术的组完成指定治疗的比例显著更高（p < 0.001），尤其是在 70 岁以下的患者中（p = 0.005）。
在长期随访后，胆囊切除术是首选治疗方法，但对于老年患者，症状性胆石病的保守治疗是手术的替代方法。
