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

Abstract

IntroductionGallbladder 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 analysisThe 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.