Carbonated soft drink for gastric preparation for magnetically controlled capsule endoscopy: An open-label randomized controlled trial

doi:10.3748/wjg.v31.i24.105823

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World Journal of Gastroenterology

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1007-9327

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Clinical Trials Study

World J Gastroenterol. Jun 28, 2025; 31(24): 105823
Published online Jun 28, 2025. doi: 10.3748/wjg.v31.i24.105823

Carbonated soft drink for gastric preparation for magnetically controlled capsule endoscopy: An open-label randomized controlled trial

Jia-Hui Zhu, Xiao Liu, Wei Zhou, Xiao-Nan Xu, Wen-Da Sheng, Yi-Lin Han, Xiao-Ou Qiu, Ya-Wei Liu, Yang-Yang Qian, Zhuan Liao, Zhao-Shen Li

Jia-Hui Zhu, Department of Gastroenterology and Endoscopy, Eastern Hepatobiliary Surgery Hospital, The Naval Medical University, Shanghai 200438, China

Jia-Hui Zhu, Xiao Liu, Wei Zhou, Xiao-Nan Xu, Wen-Da Sheng, Yi-Lin Han, Xiao-Ou Qiu, Yang-Yang Qian, Zhuan Liao, Zhao-Shen Li, Department of Digestive Diseases, National Clinical Research Center, Shanghai 200433, China

Xiao Liu, Wei Zhou, Xiao-Nan Xu, Wen-Da Sheng, Yi-Lin Han, Xiao-Ou Qiu, Yang-Yang Qian, Zhuan Liao, Zhao-Shen Li, Department of Gastroenterology, Changhai Hospital, The Naval Medical University, Shanghai 200433, China

Ya-Wei Liu, Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital/Chinese PLA Postgraduate Military Medical School, Beijing 100039, China

Co-first authors: Jia-Hui Zhu and Xiao Liu.

Co-corresponding authors: Yang-Yang Qian and Zhuan Liao.

Author contributions: Liao Z and Qian YY contributed to funding acquisition, conceptualization and project administration; Zhu JH, Liu X and Qian YY contributed to methodology and formal analysis; Zhu JH, Liu X, Zhou W, Xu XN, and Sheng WD contributed to data curation and investigation; Zhou W, Sheng WD and Liu YW contributed to visualization and software; Zhu JH, Han YL, Qiu XO, and Qian YY contributed to writing (original draft); Liao Z and Li ZS contributed to study supervision; All the authors contributed to writing (review & editing) and approved the final manuscript. Zhu JH and Liu X, as co-first authors, were integral to the study's execution. Zhu JH initiated the research protocol, handled participant recruitment and data collection, performed initial data organization and statistical analysis, and drafted the manuscript, also providing funding. Liu X conceived the research direction, collaborated on trial design specifics, supervised participant inclusion and procedures, proofread data, co-completed statistical analysis, and revised the final manuscript. Their combined efforts were crucial and indispensable. Qian YY and Liao Z, the corresponding authors, made significant and indispensable contributions. Qian YY finalized the study protocol, defined endpoints, provided technical expertise, interpreted statistical results, created figures and tables, and revised the initial draft. Liao Z, an MCE expert, validated the research protocol's scientific basis, monitored progress, ensured quality control, and approved the final conclusions and manuscript submission. Their collaboration is vital for this and future publications.

Supported by Shanghai Municipal Hospital Emerging Frontier Technology Joint Project, No. SHDC12019105; Shanghai Science and Technology Development Funds, No. 24YF2758200; and National Natural Science Foundation of China, No. 82100699.

Institutional review board statement: This study was approved by the Ethics Committee of Changhai Hospital, No. CHCE2020-117.

Clinical trial registration statement: The study was registered at ClinicalTrials.gov (NCT04479423).

Informed consent statement: All patients signed informed consent forms of this trial.

Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.

CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.

Data sharing statement: If requested, deidentified data collected for this trial, the study protocol, and informed consent form can be made available indefinitely. Please contact Zhuan Liao (liaozhuan@smmu.edu.cn), who will review all requests. Requests should fulfill the following access criteria: Research can only be conducted in collaboration with and after approval of this trial investigators, and with a signed data access and sharing agreement. The members of this trial investigators must approve all research done with the shared data.

Corresponding author: Zhuan Liao, MD, PhD, Chief Physician, Professor, Senior Researcher, Department of Gastroenterology, Changhai Hospital, The Naval Medical University, No. 168 Changhai Road, Shanghai 200433, China. zhuanleo@126.com

Received: February 14, 2025
Revised: April 14, 2025
Accepted: June 9, 2025
Published online: June 28, 2025
Processing time: 132 Days and 23.7 Hours

Abstract

BACKGROUND

The clinical effectiveness of magnetically controlled capsule endoscopy (MCE) is well established. However, problems, such as abdominal distension, insufficient gastric filling, and prolonged gastric retention time, persist with MCE gastric preparations.

AIM

To compare gastric filling using a carbonated soft drink with that using pure water during MCE.

METHODS

We performed an open-label randomised controlled trial at the Endoscopy Centre of Changhai Hospital in Shanghai. Patients aged 18-80 years, with or without gastrointestinal symptoms, scheduled for MCE were consecutively recruited. Those who provided informed consent were randomly assigned to the carbonated soft drink group (C group) or water group (W group) in a 1:1 ratio. For patients in the W group, 1000 mL of water was ingested to distend the stomach, whereas for patients in the C group, 550 mL of carbonated soft drink was provided, and patients were required to drink quickly while minimising burping. The primary endpoint was the number of patients with a gastric filling score of ≥ 4 within 5 minutes after the capsule entered the stomach.

RESULTS

From December 3, 2020 to May 17, 2021, 252 patients (141 men), aged 18-77 years, were assigned to the C (n = 126) and W (n = 126) groups. For the primary outcome, 123 patients in the C group achieved a gastric filling score of ≥ 4 (97.62% vs 80.16%, P < 0.0001). More patients in the C group had the highest gastric filling scores within the first 5 min (78.57% vs 29.37%, P < 0.0001) and 10 minutes (54.76% vs 13.49%, P < 0.0001) after the capsule entered the stomach. More patients in the W group required extra liquid for gastric refilling (1.59% vs 16.67%, P < 0.0001). Transpyloric passage of the capsule under magnetic control was successfully performed in 43 patients in the C group (P < 0.0001), accompanied by a shorter gastric transit time (53.27 ± 53.83 minutes vs 71.12 ± 52.19 minutes, P = 0.001).

CONCLUSION

Carbonated soft drinks demonstrated superior and more sustained gastric filling compared with those of water alone, with the potential to promote gastric emptying.

Keywords: Magnetically controlled capsule endoscopy; Gastric preparation; Gastric filling; Gastric emptying; Carbon dioxide; Clinical trial

Core Tip: Gastric preparation is closely related to the gastric visualisation, image quality, completion rate, and diagnostic efficacy in the widely used magnetically controlled capsule endoscopy (MCE). The gastric preparation method needs continuous optimisation. Drinking 550 mL of carbonated soft drink before MCE obtained a better gastric filling result for at least 10 minutes compared with drinking 1000 mL pure water, combined with a potential promotion of gastric emptying. This study provided a preliminary clinical assessment of a novel gastric preparation regimen for MCE. Carbonated soft drink performed better and sustained gastric filling compared with pure water for gastric preparation.