A prospective randomized noninferiority study to evaluate the safety and effectiveness of steerable ureteroscopic renal evacuation compared with standard ureteroscopy 30 day … Michael Levin Research Paper Summary

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What Was Observed? (Introduction)

  • The study compared two methods for treating kidney stones: SURE (Steerable Ureteroscopic Renal Evacuation) and URS (Ureteroscopy).
  • The main goal was to see if SURE was as good as or better than URS at removing kidney stones, with fewer stone fragments left behind after the procedure.
  • The study found that SURE was just as effective as URS at removing stones, but it cleared stones more efficiently with less leftover stone material (residual stone volume).

What is Ureteroscopy (URS)?

  • URS is a common method to treat kidney stones. It uses a thin, flexible tube with a camera (ureteroscope) inserted into the urethra, bladder, and into the ureter to reach the kidney.
  • The procedure can break stones into smaller pieces using lasers, but sometimes small fragments remain behind, which can cause further problems.

What is Steerable Ureteroscopic Renal Evacuation (SURE)?

  • SURE is a newer, improved version of URS that uses a special steerable catheter (CVAC Aspiration System) to not only break stones with a laser but also remove fragments as they are created.
  • The system uses suction to clear the stone debris, preventing pressure from building up in the kidney during the procedure.
  • SURE allows for more precise control and cleaner removal of stone fragments, improving the likelihood of being “stone-free” at the end of the procedure.

Who Were the Patients? (Patients and Methods)

  • The study included adults over 18 years old who had kidney stones between 7 mm and 20 mm in size.
  • Participants were randomly assigned to either the SURE or URS group.
  • The main measurement used to compare success between the two methods was the “stone-free rate” (SFR), which is the percentage of people who had no visible fragments remaining 30 days after the procedure.
  • Secondary measurements included stone clearance (how much of the stone was removed) and residual stone volume (how much stone remained).

What Were the Key Results? (Study Results)

  • There was no significant difference in the primary outcome between SURE and URS, meaning both methods had nearly the same “stone-free rate” after 30 days (48% for SURE vs 49% for URS).
  • SURE performed better in secondary outcomes:
    • SURE cleared more stone volume than URS (96.9% vs 92.9%).
    • SURE left less residual stone material (14.3 mm³ vs 70.2 mm³).
  • For patients with larger stone volumes, SURE performed better, whereas URS effectiveness decreased as stone size increased.
  • Both procedures had similar safety outcomes with no major complications in either group.

How Were the Procedures Done? (Treatment Process)

  • Both groups first underwent laser treatment to break the stones into smaller pieces.
  • In the SURE group, a special suction catheter was introduced to remove stone fragments while continuing to break them apart with the laser. This made the procedure more effective at clearing stones.
  • The URS group had stones broken up and removed manually, using a technique known as “basketing” to grab and remove fragments.
  • In both groups, a stent was placed in the ureter to help with healing after the procedure.

What Were the Outcomes? (Results and Recovery)

  • Both groups showed no significant differences in safety, with mild adverse events such as minor bleeding or discomfort.
  • The SURE group had better outcomes for stone clearance and left less stone material behind.
  • Overall, the SURE procedure achieved better stone removal efficiency, regardless of the initial stone size.
  • There were no major complications in either group, and all adverse events were mild and resolved on their own.

Key Conclusions (Study Conclusion)

  • SURE showed similar effectiveness to URS in achieving stone-free outcomes, but it removed more stone material with fewer leftover fragments.
  • SURE’s improved performance was independent of the stone size, making it more reliable for larger stones, unlike URS which struggled with larger stones.
  • While both methods had low complication rates, SURE’s better stone clearance and lower residual stone volume may offer long-term benefits, particularly for patients with larger stones.
  • More research is needed to understand the full benefits of SURE over longer periods and with different patient populations.

研究观察到的结果 (引言)

  • 本研究比较了两种治疗肾结石的方法:SURE(可调式输尿管肾脏清除术)和URS(输尿管镜检查)。
  • 主要目标是查看SURE是否与URS一样有效,或者比URS更有效,能够在治疗后留下更少的结石碎片。
  • 研究发现,SURE与URS在清除结石方面效果相当,但SURE在清除结石碎片方面更高效,且残留的结石物质(残留结石体积)更少。

什么是输尿管镜检查 (URS)?

  • URS是一种常见的肾结石治疗方法,使用一根细长、灵活的管子(输尿管镜)插入尿道、膀胱,进入输尿管,最终到达肾脏。
  • 该过程可以使用激光将结石击碎,但有时仍会留下小碎片,这可能导致进一步的问题。

什么是可调式输尿管肾脏清除术 (SURE)?

  • SURE是一种新型的输尿管镜检查,使用特殊的可调管道(CVAC吸引系统),不仅使用激光击碎结石,还在结石破碎过程中立即清除碎片。
  • 该系统使用吸力清除结石碎片,避免在治疗过程中肾脏内压力过高。
  • SURE提供了更精确的控制,并能更彻底地清除结石碎片,增加了手术后无结石的概率。

患者是谁? (患者和方法)

  • 研究纳入了18岁以上的成人,肾结石大小在7mm到20mm之间的患者。
  • 参与者被随机分配到SURE组或URS组。
  • 主要衡量标准是“无结石率”(SFR),即治疗后30天没有可见碎片的患者百分比。
  • 次要衡量标准包括结石清除率(去除的结石量)和残余结石体积(剩余结石量)。

关键结果是什么? (研究结果)

  • 主要结果显示,SURE和URS之间没有显著差异,30天后的无结石率几乎相同(SURE为48%,URS为49%)。
  • 在次要结果上,SURE表现得更好:
    • SURE清除了更多的结石体积(96.9% vs 92.9%)。
    • SURE留下的残余结石物质更少(14.3 mm³ vs 70.2 mm³)。
  • 对于石块较大的患者,SURE表现更好,而URS的效果随着石块大小的增加而降低。
  • 两种方法的安全性相似,没有重大并发症。

手术过程如何进行? (治疗过程)

  • 两组患者首先接受激光治疗,将结石打碎成小块。
  • SURE组使用特殊的吸引导管将碎片移除,同时继续使用激光进行碎石,使得该过程更加高效。
  • URS组使用“篮式取出”方法手动去除碎片。
  • 两组患者都在治疗后放置了导尿管以帮助愈合。

结果如何? (结果与恢复)

  • 两组的安全性没有显著差异,所有的不良事件都是轻微的,并且自行解决。
  • SURE组在结石清除和残留结石体积方面表现更好。
  • 总体来说,SURE提供了更好的结石去除效率,且无论石块大小如何都更可靠。
  • 没有重大并发症,所有的不良事件都很轻微,并迅速恢复。

主要结论 (研究结论)

  • SURE在治疗肾结石方面与URS同样有效,但它能更高效地去除结石碎片,且留下的残余结石物质较少。
  • SURE的效果与石块大小无关,这使得它在处理大结石时比URS更可靠。
  • 尽管两种方法的并发症率较低,SURE的结石清除率和残留结石体积较低可能提供长期的好处,尤其对于石块较大的患者。
  • 需要更多的研究来了解SURE在更长时间内的效果,以及不同患者群体中的应用。