Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis: a Multicenter International Randomized Controlled Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Ideal 30-day outcome
研究概览
简要总结
The goal of this clinical trial is to learn if endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) works better than percutaneous gallbladder drainage (PT-GBD) for people with acute cholecystitis (inflammation of the gallbladder) who cannot undergo immediate surgery.
The main questions this study aims to answer are:
- Does EUS-GBD lead to fewer serious medical problems and fewer additional procedures within 30 days after treatment?
- Does EUS-GBD improve quality of life compared with PT-GBD?
Researchers will compare two methods of draining the gallbladder to see which treatment leads to better outcomes.
Participants will:
- Be randomly assigned to receive either EUS-GBD or PT-GBD.
- Receive gallbladder drainage performed by experienced specialists.
- Complete questionnaires about their health and quality of life before treatment and during follow-up.
- Have follow-up visits or telephone consultations at 7, 30, 182, and 365 days after the drainage procedure.
The study will include participants from hospitals in several (European) countries.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- ≥ 18 years
- Definite diagnosis of acute cholecystitis following the Tokyo guidelines
- Poor surgical patients, not eligible for acute cholecystectomy according to their surgeon, with indication for gallbladder drainage.b The reason for ineligibility is recorded.
- Possibility to obtain written informed consent from the patient or their legal representative.
- Drainage with both modalities is technically feasible (i.e. the gallbladder can be accessed with both techniques), as assessed by the treating physician and/or expert panel.
排除标准
- Presence of a non-sealed perforated gallbladder. In case of a sealed perforation, patients can be included after assessment of an expert panel.
- Need of dual treatment with both modalities, already established beforehand.
- Prior gallbladder drainage attempts.
- Surgically altered anatomy (i.e. alterations to the oesophagus, stomach and duodenum).
- The presence of contraindications to either drainage modality, unless it is a temporary problem that can be mitigated beforehand (i.e. ascites drainage prior to percutaneous drainage).
- Permanently incapacitated and therefore inability to fill out the quality of life surveys.
研究组 & 干预措施
PT-GBD
The control group will receive standard treatment, i.e. PT-GBD.
干预措施: Percutaneous gallbladder drainage (Procedure)
EUS-GBD
The intervention group will receive transduodenal EUS-GBD with a lumen apposing metal stent (LAMS) with a co-axial pigtail stent placed through the LAMS.
干预措施: Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS) (Procedure)
结局指标
主要结局
Ideal 30-day outcome
时间窗: 30 days after index drainage procedure
The primary outcome is the ideal 30-day outcome, consisting of the absence of severe adverse events (AGREE grade ≥ II) and non-elective reinterventions for drainage or pancreato-biliary events.
Health-related quality of life measured by the EQ-5D-5L
时间窗: At day 7 and 30 after index intervention
Health-related quality of life assessed using the EQ-5D-5L. The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five response levels. Responses are converted to a single index value using a country-specific value set. Index values are anchored at 1 (full health) and 0 (a state equivalent to death), with negative values possible for states considered worse than death; higher index values indicate better health-related quality of life. Assessments at day 7 and day 30 will be combined into a single cumulative value; the exact value set and method of aggregation will be prespecified in the Statistical Analysis Plan.
Quality of Life at day 7 and 30
时间窗: At day 7 and 30 after index intervention
Health-related quality of life assessed using the PROMIS Global-10 (Patient-Reported Outcomes Measurement Information System Global Health short form). Raw scores are converted to T-scores standardised to a mean of 50 and a standard deviation of 10 in the reference population; higher scores indicate better global physical and mental health. Assessments at day 7 and day 30 will be combined into a single cumulative value; the exact scoring and method of aggregation will be prespecified in the Statistical Analysis Plan.
次要结局
- Individual components of the ideal 30-day outcome(30 days after drainage procedure)
- Technical and clinical success of gallbladder drainage(During the index procedure and within 48 hours after drainage)
- Adverse events after gallbladder drainage(6 and 12 months after the drainage procedure)
- Number of reinterventions after gallbladder drainage(12 months after the drainage procedure)
- Length of intensive care unit and hospital stay(From diagnosis until 12 months follow-up)
- Recurrent (pancreato-)biliary events(12 months after the drainage procedure)
- Mortality(12 months after the drainage procedure)
- 30 post-operative adverse events after interval cholecystectomy graded by AGREE classification(30 days after interval cholecystectomy)
研究者
Rogier P. Voermans
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
标识符
- NCT 编号
- NCT07792486
- 其他研究编号
- NL-011026
日期
- 首次提交
- (2个月前)
- 首次发布
- (上个月)
- 主要完成日期
- (2年后)
- 研究完成日期
- (3年后)
- 最近核实
- (3个月前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否