Department of Surgery, Emek Medical Center, 21 Izhak Rabin Blvd, 1834111, Afula, Israel.
The Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
Updates Surg. 2020 Dec;72(4):1125-1133. doi: 10.1007/s13304-020-00850-2. Epub 2020 Jul 14.
Although bariatric surgery (BS) predisposes patients to development of gallstone formation, a preventive strategy is still in debate.
To compare the incidence of gallstone formation between patients treated with ursodeoxycholic acid (UDCA) vs. placebo for a duration of 6 months following BS.
This multicenter randomized, double-blind controlled trial entails treatment with UDCA vs. an identical-looking placebo. The primary outcome was gallstone formation, as measured by abdominal ultrasound.
The data of 209 subjects were enrolled in the study, and 92 subjects completed the study and were analyzed (n = 46 for each study group). The high dropout rate was mainly due to difficulties in adding more medications and swallowing the pill. Among the subjects who completed the study, 77.2% were women, and their mean age and pre-surgery BMI were 42.2 ± 10.2 years and 44.4 ± 6.1 kg/m, respectively. Gallstone formation was recorded in 45.7% (n = 21) vs. 23.9% (n = 11) of subjects among placebo vs. UDCA groups, respectively, p = 0.029. Subgroup-analysis, according to surgery type, found that the results were significant only for SG subjects (p = 0.041), although the same trend was observed for OAGB/RYGB. Excess Weight Loss percent (%EWL) at 6 months post-surgery was 66.0 ± 17.1% vs. 71.8 ± 19.5% for the placebo and UDCA groups, respectively; p = 0.136. A trend towards a reduction in prescribed comorbidity medications was noted within-groups during the follow-up period, as compared to baseline, with no between-group differences (p ≥ 0.246). Moreover, no between-group differences were found for blood test results (p ≥ 0.063 for all).
Administration of UDCA significantly decreased gallstone formation at 6 months at following BS. CLINICALTRIALS.
NCT02319629.
尽管减重手术（BS）使患者易发生胆石形成，但预防策略仍存在争议。
比较 BS 后 6 个月内使用熊去氧胆酸（UDCA）与安慰剂治疗的患者胆石形成的发生率。
这项多中心随机、双盲对照试验包括使用 UDCA 与外观相同的安慰剂治疗。主要结局是通过腹部超声测量胆石形成。
共有 209 名受试者入组该研究，92 名受试者完成研究并进行分析（每组 n=46）。高脱落率主要是由于难以添加更多药物和吞咽药丸。在完成研究的受试者中，77.2%为女性，平均年龄和术前 BMI 分别为 42.2±10.2 岁和 44.4±6.1kg/m2。安慰剂组和 UDCA 组的胆石形成分别记录为 45.7%（n=21）和 23.9%（n=11），p=0.029。根据手术类型的亚组分析发现，结果仅在 SG 受试者中具有统计学意义（p=0.041），尽管 OAGB/RYGB 也存在同样趋势。术后 6 个月的 excess weight loss %（%EWL）分别为安慰剂组和 UDCA 组的 66.0±17.1%和 71.8±19.5%；p=0.136。与基线相比，在随访期间，每个组内的规定合并症药物用量呈减少趋势，但组间无差异（p≥0.246）。此外，组间血液检查结果无差异（p≥0.063）。
BS 后 6 个月内使用 UDCA 可显著降低胆石形成。临床试验。
NCT02319629。
