Construction and Application of an AI Model for Guided TIPS Surgical Puncture: a Prospective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Number of punctures
研究概览
简要总结
The goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (TIPS)-guided AI model can guide TIPS procedure in adults better than conventional TIPS procedure (artificially blinded TIPS). TIPS surgical outcomes and intraoperative and postoperative complications will also be observed. The main questions it aims to answer are:
- Does the AI model lower the number of punctures, radiation dose, and complications of participants undergo TIPS?
- Does the AI model improve the efficacy of TIPS for participants?
Participants will:
- Take the TIPS by the guidance of the AI model or conventional manually blinded penetration (placebo)
- The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications within 3 months will be recorded
- Intraoperative portal pressure gradient drop values, symptoms of ascites and rebleeding within 3 months after TIPS will be reported
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.
- •Participants whose physical condition is suitable for TIPS.
排除标准
- •Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
- •Participants are pregnant or breastfeeding.
- •Participants are unwilling or unable to sign informed consent.
研究组 & 干预措施
AI guided TIPS
TIPS procedure will be conducted under the guidance of AI model
干预措施: AI guided TIPS (Other)
Artificially blinded TIPS
TIPS will be conducted based on the experience of operators.
干预措施: Artificially blinded TIPS (Other)
结局指标
主要结局
Number of punctures
时间窗: From the beginning to the end of the TIPS procedure.
The number of punctures is defined as the number of punctures to the liver during the establishment of the puncture channel during the TIPS procedure.
次要结局
- Radiation dose(From the beginning to the end of the TIPS procedure.)
- Surgical success rate(From the beginning to the end of the TIPS procedure.)
- Complications(From enrollment to the end of the TIPS procedure at 3 months.)