Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial-Reference-Cited by-同舟云学术

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

Published:2023-08-24 Issue: Volume: Page:
ISSN:0366-6999
Container-title:Chinese Medical Journal
language:en
Short-container-title:

Author:

Meng Wenbo¹²,Leung Joseph W.³,Wang Zhenyu⁴,Li Qiyong⁵,Zhang Leida⁶,Zhang Kai⁷,Wang Xuefeng⁸,Wang Meng⁹,Wang Qi¹⁰,Shao Yingmei¹¹,Zhang Jijun¹²,Yue Ping¹²,Zhang Lei¹²,Zhu Kexiang¹²,Zhu Xiaoliang¹²,Zhang Hui¹³,Hou Senlin¹⁴,Cai Kailin¹⁵,Sun Hao¹⁶,Xue Ping¹⁷,Liu Wei¹⁸,Wang Haiping²,Zhang Li⁴,Ding Songming⁵,Yang Zhiqing⁶,Zhang Ming⁷,Weng Hao⁸,Wu Qingyuan⁹,Chen Bendong¹⁰,Jiang Tiemin¹¹,Wang Yingkai¹²,Zhang Lichao¹⁴,Wu Ke¹⁵,Yang Xue¹⁶,Wen Zilong¹⁷,Liu Chun¹⁸,Miao Long¹²,Wang Zhengfeng¹²,Li Jiajia²,Yan Xiaowen²,Wang Fangzhao¹,Zhang Lingen¹,Bai Mingzhen¹⁹,Mi Ningning¹⁹,Zhang Xianzhuo¹⁹,Zhou Wence¹³,Yuan Jinqiu²⁰,Suzuki Azumi²¹,Tanaka Kiyohito²²,Liu Jiankang²³,Nur Ula²⁴,Weiderpass Elisabete²⁵,Li Xun¹²

Affiliation:

1. Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, Gansu 730000, China

2. Key Laboratory of Biological Therapy and Regenerative Medicine Transformation Gansu Province, Lanzhou, Gansu 730000, China

3. Division of Gastroenterology and Hepatology, UC Davis Medical Center, Sacramento, CA 95816, USA

4. Department of Minimally Invasive Surgery, Tianjin Nankai Hospital, Tianjin 300100, China

5. Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University, Hangzhou, Zhejiang 310000, China

6. Department of Hepatobiliary Surgery, Southwest Hospital, Army Medical University, Chongqing 400000, China

7. Hepatobiliary Surgery Department, Shandong Provincial Third Hospital, Jinan, Shandong 250000, China

8. Department of General Surgery, Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Biliary Tract Disease Research, Shanghai 200000, China

9. Department of Hepatobiliary and Pancreatic Surgery, The First Hospital of Jilin University, Changchun, Jilin 130000, China

10. Department of Hepatobiliary Surgery, The General Hospital of Ningxia Medical University, Yinchuan, Ningxia 750000, China

11. Department of Hepatobiliary & Hydatid, Digestive and Vascular Surgery Center, Xinjiang Key Laboratory of Echinococcosis and Liver Surgery Research, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang 830000, China

12. Department of Hepatobiliary and Pancreatic Surgery, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030000, China

13. Department of General Surgery, The Second Hospital of Lanzhou University, Lanzhou, Gansu 730000, China

14. Department of Biliopancreatic Endoscopic Surgery, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, China

15. Gastrointestinal Surgery Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430000, China

16. Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi 710000, China

17. Department of Hepatobiliary Surgery, the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510260, China

18. Division of Biliopancreatic Surgery, Department of General Surgery, Second Xiangya Hospital, Central South University, Changsha, Hunan 410000, China

19. The First Clinical Medical College of Lanzhou University, Lanzhou, Gansu 730000, China

20. Clinical Research Centre, Scientific Research Centre, The Seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen, Guangdong 518000 China

21. Department of Gastroenterology, Hamamatsu Medical Center, Hamamatsu 9800021, Japan

22. Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto 201101, Japan

23. Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA

24. Department of Public Health, College of Health Sciences, Qatar University, Doha 2713, Qatar

25. International Agency for Research on Cancer (IARC), Lyon 69000, France.

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

General Medicine,General Medicine

Reference31 articles.

1. Endoscopic cannulation of the ampulla of vater: A preliminary report;McCune;Ann Surg,1968

2. The future of endoscopic retrograde cholangiopancreatography;Yachimski;Gastroenterology,2017

3. Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: A multicentre, single-blinded, randomised controlled trial;Meng;Lancet Gastroenterol Hepatol,2019

4. Endoscopic retrograde cholangiopancreatography-related complications and their management strategies: A "scoping" literature review;Johnson;Dig Dis Sci,2020

5. Perioperative fasting: A review;Dorrance;J Perioper Pract,2020