Effect of Same-session Endoscopic Ultrasonography on Endoscopic Retrograde Cholangiopancreatography in Pancreaticobiliary Diseases: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- ERCP strategy modification rate
研究概览
简要总结
This is a single-center randomized controlled trial. Eligible subjects meeting inclusion/exclusion criteria will be randomized 1:1 to EUS+ERCP group or ERCP group. Clinical data and patient-reported outcomes are regularly collected at baseline and during follow-up periods. A comparative analysis was conducted to assess the impact of same-session EUS on ERCP strategy modification between two groups, utilizing a structured questionnaire.Secondarily, the safety and efficacy of same-session EUS will be comprehensively evaluated by comparing complication rates, technical success rate and hospitalization costs, length of stay, and radiation exposure between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patients aged ≥18 years;
- •Patients with pancreaticobiliary diseases definitively indicated for ERCP (as confirmed by HBP Specialists );
- •No prior history of ERCP;
- •No pancreaticobiliary EUS examinations within the preceding 3 months.
排除标准
- •Patients with clinically confirmed malignant lesions deemed surgically unresectable by multidisciplinary evaluation and requiring pathological diagnosis exclusively for chemotherapy/radiotherapy guidance;
- •Patients with confirmed diagnosis requiring only palliative biliary/pancreatic stent placement for obstructive jaundice ;
- •Patients with anatomical alterations or surgical history affecting EUS feasibility;
- •Severe systemic illness including severe hepatic, renal, cardiopulmonary and cerebrovascular diseases with high risk for endoscopic procedures;
- •Contraindication to iodinated contrast media (allergy or renal impairment preventing ERCP);
- •Pregnancy or lactation;
- •Patients with severe coagulopathy;
- •Declined informed consent;
- •Severe psychiatric disorder/non-cooperation precluding safe procedure.
研究组 & 干预措施
EUS+ERCP group
EUS and ERCP were performed during the same session under continuous sedation/anesthesia in the intervention group.
干预措施: EUS+ERCP (Procedure)
ERCP group
Only ERCP was performed in the control group
干预措施: ERCP (Procedure)
结局指标
主要结局
ERCP strategy modification rate
时间窗: From enrollment to 6 months after the end of treatment
Concordance rate between anticipated and actual ERCP procedural strategies and the rate of avoiding unnecessary ERCP procedures.
次要结局
- Procedure outcomes(From enrollment to 6 months after the end of treatment)
- Incidence of complications(From enrollment to 6 months after the end of treatment)
- Radiation-related situation(From enrollment to 6 months after the end of treatment)
- Healthcare utilization measures(From enrollment to 6 months after the end of treatment)