高碳水化合物液饮食 2 小时与非紧急内镜逆行胰胆管造影前 overnight fasting 的安全性：一项单盲、多中心、随机对照试验。
Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial.
机构信息
Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, Gansu 730000, China.
Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, Gansu 730000, China.
出版信息
Chin Med J (Engl). 2024 Jun 20;137(12):1437-1446. doi: 10.1097/CM9.0000000000002820. Epub 2023 Aug 24.
BACKGROUND
Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients' recovery.
METHODS
This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle.
RESULTS
The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t = 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26-0.71, P <0.001) and 0.76 (95% CI: 0.57-0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05-0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39-0.95, P = 0.028) in the multivariable models.
CONCLUSION
Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.
TRAIL REGISTRATION
ClinicalTrials.gov , No. NCT03075280.
背景
尽管推荐内镜逆行胰胆管造影术（ERCP）前进行隔夜禁食，但在 ERCP 前 2 小时摄入高碳水化合物饮食（CFD）的益处和安全性仍不清楚。本研究旨在分析 ERCP 前 2 小时摄入高 CFD 是否安全，并加速患者的康复。
方法
这是一项前瞻性、多中心、随机对照试验，涉及 15 个三级 ERCP 中心。共有 1330 名患者被随机分为 CFD 组（n=665）和禁食组（n=665）。CFD 组在 ERCP 前 2 小时口服 400 毫升麦芽糊精，而对照组在 ERCP 前禁食/饮水超过 6 小时。所有 ERCP 操作均采用静脉注射丙泊酚进行深度镇静。研究人员被蒙蔽，但患者未被蒙蔽。主要结局包括术后疲劳和腹痛评分，次要结局包括并发症和代谢指标的变化。根据修改后的意向治疗原则分析结果。
结果
CFD 组在术后 4 小时（4.1±2.6 与 4.8±2.8，t=4.23，P<0.001）和 20 小时（2.4±2.1 与 3.4±2.4，t=7.94，P<0.001）的术后疲劳评分显著降低，最小二乘均数差异分别为 0.48（95%置信区间[CI]：0.26-0.71，P<0.001）和 0.76（95%CI：0.57-0.95，P<0.001）。4 小时疼痛评分（2.1±1.7 与 2.2±1.7，t=2.60，P=0.009，最小二乘均数差异为 0.21[95%CI：0.05-0.37]）和阳性尿酮水平（7.7%[39/509]与 15.4%[82/533]，χ2=15.13，P<0.001）在 CFD 组较低。CFD 组胆管炎的发生率较低（2.1%[13/634]与 4.0%[26/658]，χ2=3.99，P=0.046），但胰腺炎的发生率无差异（5.5%[35/634]与 6.5%[43/658]，χ2=0.59，P=0.444）。亚组分析显示，在多变量模型中，CFD 降低了原发性乳头患者并发症的发生率（比值比[OR]：0.61，95%CI：0.39-0.95，P=0.028）。
结论
ERCP 前 2 小时摄入 400 毫升 CFD 是安全的，可减少术后疲劳、腹痛和恢复期间的胆管炎。
临床试验注册
ClinicalTrials.gov，编号 NCT03075280。
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