DOI: 10.1097/cm9.0000000000002820 ISSN:

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

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

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], χ 2 = 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], χ 2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ 2 = 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.

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