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临床试验/NCT06278090
NCT06278090进行中(未招募)不适用

Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution. Prospective Cohort Study

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
36
试验地点
2
主要终点
Reducing gallbladder polyp size by 2mm or more

研究概览

简要总结

The goal of this observational study is to learn about the impact of ursodeoxycholic acid treatment on the gallbladder polyp evolution in patients with gallbladder polyps that undergo follow up. The main question it aims to answer is:

• Whether ursodeoxycholic acid could decrease the gallbladder polyp size and therefore spare unnecessary follow up or surgical interventions

Participants will be managed according to the standard practice of the department they are attended:

  • According to the established practice in the Department of Surgery, patients that either do not have an indication for cholecystectomy or decline the offered intervention, and are subjects for a follow up, are usually prescribed Ursodeoxycholic Acid, at 10-15 mg/kg/day for at least 6 months.
  • According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines.

Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differs significantly.

详细描述

Gallbladder polyps are common findings on abdominal ultrasound studies. Most of them are cholesterol polyps. However, often they require a prolonged follow up due to impossibility to efficiently rule out the presence of a real adenomatous polyps with potential of malignization.

Ursodeoxycholic Acid is a well-studied and long known drug that has been used for conservative treatment of bile stones with high cholesterol concentration (most of them), but also for bile sludge and gallbladder polyps, that are considered precursors of the gallbladder stones. It has been found in several studies that prevent from recurrent idiopathic acute pancreatitis and from gallbladder stone formation after gastric (including bariatric) surgery.

Participants will be managed according to the standard practice of the department they are attended:

  • According to the established practice in the Department of Surgery, patients that either do not have an indication for cholecystectomy or decline the offered intervention, and are subjects for a follow up, are usually prescribed ursodeoxycholic acid, at 10-15 mg/kg/day for at least 6 months.
  • According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines.

Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differ significantly during the studied period of 1 year. The small size changes could have a great impact on the management of the gallbladder polyps as for a 2mm increase could be a reason to indicate a surgical intervention and a 2mm decrease could cause the discontinuation of the follow up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with gallbladder polyps eligible for standard follow up (without indication for cholecystectomy or patient decline surgery or polyps < 5mm without risk factors such as age>60 years, primary sclerosing cholangitis, asian ethnicity, sessile polypoid lesion)

排除标准

  • Patients with gallbladder polyps that received ursodeoxycolic acid doses lower than 10mg/kg/day

研究组 & 干预措施

Patients treated with Ursodeoxycholic acid

Patients that recieved prescription for Ursodeoxycholic acid, 10-15 mg/kg for at least 6 months.

干预措施: Ursodeoxycholic Acid Only Product (Drug)

Patients not treated with Ursodeoxycholic acid

Patients without prescription of Ursodeoxycholic acid

结局指标

主要结局

Reducing gallbladder polyp size by 2mm or more

时间窗: 6 and 12 months

Reducing the polyp size by 2mm or more, at the usual ultrasonographic controls at 6 and 12 months.

次要结局

  • Modification of the expected follow up(12 months)

研究者

发起方
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tihomir Georgiev Hristov

Principal Investigator

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

研究点 (2)

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