Медицинская библиотека · Chinese medical journal · 2023

Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial.

Meng Wenbo, Leung Joseph W, Wang Zhenyu, Li Qiyong, Zhang Leida, Zhang Kai, Wang Xuefeng, Wang Meng, Wang Qi, Shao Yingmei, Zhang Jijun, Yue Ping, Zhang Lei, Zhu Kexiang, Zhu Xiaoliang, Zhang Hui, Hou Senlin, Cai Kailin, Sun Hao, Xue Ping, Liu Wei, Wang Haiping, Zhang Li, Ding Songming, Yang Zhiqing, Zhang Ming, Weng Hao, Wu Qingyuan, Chen Bendong, Jiang Tiemin, Wang Yingkai, Zhang Lichao, Wu Ke, Yang Xue, Wen Zilong, Liu Chun, Miao Long, Wang Zhengfeng, Li Jiajia, Yan Xiaowen, Wang Fangzhao, Zhang Lingen, Bai Mingzhen, Mi Ningning, Zhang Xianzhuo, Zhou Wence, Yuan Jinqiu, Suzuki Azumi, Tanaka Kiyohito, Liu Jiankang, Nur Ula, Weiderpass Elisabete, Li Xun

СтатьяРандомизированное исследованиеМногоцентровое исследованиеПеревод в очереди

Аннотация

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.

Для цитирования: Meng Wenbo, Leung Joseph W, Wang Zhenyu, Li Qiyong, Zhang Leida, Zhang Kai, Wang Xuefeng, Wang Meng, Wang Qi, Shao Yingmei, Zhang Jijun, Yue Ping, Zhang Lei, Zhu Kexiang, Zhu Xiaoliang, Zhang Hui, Hou Senlin, Cai Kailin, Sun Hao, Xue Ping, Liu Wei, Wang Haiping, Zhang Li, Ding Songming, Yang Zhiqing, Zhang Ming, Weng Hao, Wu Qingyuan, Chen Bendong, Jiang Tiemin, Wang Yingkai, Zhang Lichao, Wu Ke, Yang Xue, Wen Zilong, Liu Chun, Miao Long, Wang Zhengfeng, Li Jiajia, Yan Xiaowen, Wang Fangzhao, Zhang Lingen, Bai Mingzhen, Mi Ningning, Zhang Xianzhuo, Zhou Wence, Yuan Jinqiu, Suzuki Azumi, Tanaka Kiyohito, Liu Jiankang, Nur Ula, Weiderpass Elisabete, Li Xun. Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial.. Chinese medical journal. 2023. DOI: 10.1097/cm9.0000000000002820.

Предметные рубрики MeSH

Humans Cholangiopancreatography, Endoscopic Retrograde Male Female Middle Aged Prospective Studies Fasting Adult Aged Single-Blind Method

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