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Protocol | Open Access

Danning tablets for the treatment of multiple gallbladder polyps: Study protocol of multicentre, randomised, open-labelled, controlled trial

Tian Yanga,1( )Ming-Da Wanga,1Gui-Lin Xieb,1Xiong-Hua WangcLiu ZhengdLi-Min WangeGuang-Fa XiaofYong-Qing YanggChao LiaAlfred Wei Chieh KowhFeng Shena( )
Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai 200438, China
Department of Hepatobiliary Pancreatic Surgery, Affiliated Hospital of Shaoxing University, Shaoxing 312099, China
Department of Hepatobiliary Surgery, Ningbo Hospital of Traditional Chinese Medicine, Ningbo 315010, China
Department of Hepatobiliary Surgery, The Sixth People’s Hospital of Chengdu, Chengdu 610051, China
Department of Hepatobiliary Surgery, Tangshan Central Hospital, Tangshan 063016, China
Department of Hepatobiliary Surgery, Xiangya Changde Hospital, Changde 415009, China
Department of Hepatobiliary Surgery, Loudi Central Hospital, Loudi 417099, China
Division of Hepatopancreaticobiliary Surgery and Liver Transplantation, Department of Surgery, National University Health System Singapore, Singapore 119615, Singapore

1 These authors contributed equally to this work and are joint first authors.

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Abstract

Introduction

Gallbladder polyps (GPs) are protrusions of the gallbladder wall into the lumen, and are commonly detected during ultrasound examinations. Traditional management of multiple GPs (MGPs) has been conservative, including lifestyle interventions, regular monitoring, and surgical intervention in certain cases, but this approach poses risks of polyps enlargement and increase of number, as well as patients’ psychological burdens. Danning Tablets, a traditional Chinese medicine, have emerged as a potential non-surgical treatment for GPs, showing promise in reducing polyp size and alleviating symptoms, backed by their anti-inflammatory and antitumor properties demonstrated in preclinical studies. This suggests the need for further research into Danning Tablets as an alternative treatment for MGPs.

Methods and analysis

The study is designed as a prospective, randomized, controlled, open-label trial. The study will be conducted across multiple centres specializing in gastroenterology and hepatology. Participants will be recruited from these centres, ensuring a diverse patient demographic. Adult patients diagnosed with MGPs, based on ultrasound findings, will be included. Exclusion criteria include patients with a history of gallbladder cancer, previous gallbladder surgery, or serious comorbid conditions. The control group will receive standard care, including dietary and lifestyle advice, while the intervention group will receive Danning Tablets and standard care. The dosage and administration of Danning Tablets will follow established clinical guidelines. The primary outcome will be the change in size of the largest gallbladder polyps on week 24 ± 1, measured by ultrasound. The secondary outcomes will include symptom improvement and recording of any adverse events. The study will span over a period of 6 months, with periodic assessments at baseline, 4, 8, 12, and 24 weeks.

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iLIVER
Article number: 100127
Cite this article:
Yang T, Wang M-D, Xie G-L, et al. Danning tablets for the treatment of multiple gallbladder polyps: Study protocol of multicentre, randomised, open-labelled, controlled trial. iLIVER, 2024, 3(4): 100127. https://doi.org/10.1016/j.iliver.2024.100127

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Received: 25 October 2024
Revised: 28 October 2024
Accepted: 29 October 2024
Published: 06 November 2024
© 2024 The Author(s). Tsinghua University Press.

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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