Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Feb 16, 2024; 16(2): 83-90
Published online Feb 16, 2024. doi: 10.4253/wjge.v16.i2.83
Coca-Cola consumption vs fragmentation in the management of patients with phytobezoars: A prospective randomized controlled trial
Fu-Guo Liu, De-Feng Meng, Xia Shen, Dan Meng, Ying Liu, Ling-Yun Zhang
Fu-Guo Liu, De-Feng Meng, Xia Shen, Dan Meng, Ying Liu, Department of Gastroenterology, The Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China
Ling-Yun Zhang, Endoscopy Center, The Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China
Author contributions: Liu FG designed the study and reviewed the manuscript. Liu Y and Shen X collected the data; Meng DF analyzed the data. Meng D and Zhang LY wrote and drafted the manuscript; all authors have read and approve the final manuscript.
Institutional review board statement: This study was approved by the Institutional Review Board of the Affiliated Hospital of Qingdao University (QYFYWZLL 26293).
Clinical trial registration statement: The study was registered in the ClinicalTrial.gov Protocol Registration System, registration No. NCT05645263.
Informed consent statement: All study participants or their legal guardian provided informed written consent about personal and medical data collection prior to study enrolment.
Conflict-of-interest statement: All the authors declare that they have no conflicts of interest regarding this work.
Data sharing statement: All data available from the corresponding author at zhanglingyun@qdu.edu.cn
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ling-Yun Zhang, MA, Adjunct Associate Professor, Endoscopy Center, The Affiliated Hospital of Qingdao University, No. 59 Haier Road, Qingdao 266000, Shandong Province, China. zhanglingyun@qdu.edu.cn
Received: October 28, 2023
Peer-review started: October 28, 2023
First decision: December 29, 2023
Revised: January 4, 2024
Accepted: January 16, 2024
Article in press: January 16, 2024
Published online: February 16, 2024
Processing time: 95 Days and 3 Hours
ARTICLE HIGHLIGHTS
Research background

With the publication of Ladas SD’s article (Systematic review: Coca-Cola can effectively dissolve gastric phetobezoars as a first-line treatment), Coca-Cola dissolution therapy in patients with gastric phytobezoars (GPBs) is gradually being accepted in clinical practice. However, existing studies on this subject are often case reports highlighting the successful dissolution of phytobezoars using Coca-Cola. Consequently, large-scale prospective investigations in this domain remain scarce. Therefore, we conducted a randomized controlled trial to examine the effects of Coca-Cola administration on GPBs.

Research motivation

This study evaluated the intervention treatment of patients with Coca-Cola dissolution therapy, including the complete resolution rate, gastric ulcer rate, medical expenses and endoscopic operation time. Additionally, this study aimed to find a treatment plan that can attain the expected results and minimize the side effects.

Research objectives

The aim was to evaluate the impact of Coca-Cola on GPBs, including the dissolution rate, medical expenses, ulcer rate, and operation time.

Research methods

In this study, a total of 160 consecutive patients diagnosed with GPBs were allocated into two groups (a control group and an intervention group) through computer-generated randomization. Patients in the intervention group were receive a Coca-Cola-based regimen (Coca-Cola 2000-4000 mL per day for 7 d), while those in the control group underwent emergency fragmentation.

Research results

Complete dissolution of GPBs was achieved in 100% of the patients in the intervention group. The disparity in expenses between the control group and intervention group (t = 25.791, P = 0.000) was statistically significant, and the difference in the gastric ulcer occurrence rate between the control group and intervention group (χ2 = 6.181, P = 0.013) was also statistically significant.

Research conclusions

Timely ingestion of Coca-Cola yields significant benefits, including a complete dissolution rate of 100%, a low incidence of gastric ulcers, no need for fragmentation and reduced expenses.

Research perspectives

This treatment is beneficial for relieving patients’ pain, reducing the need for emergency gastroscopy, decreasing medical expenses and lowering the gastric ulcer rate. Therefore, Coca-Cola dissolution therapy for GPBs is a safe, feasible, simple and effective method that is worthy of clinical application and promotion.