One-step percutaneous nephrolithotomy sheath versus standard two-step technique

Area of Science:

• Urology
• Minimally Invasive Surgery
• Medical Device Technology

Background:

• Percutaneous nephrolithotomy (PCNL) is the gold standard for large renal calculi.
• Traditional PCNL access involves a two-step dilation process, which can be time-consuming.
• A novel single-step device, the Pathway Access Sheath (PAS), has been developed to simplify PCNL access.

Purpose of the Study:

• To evaluate the safety and efficacy of the novel Pathway Access Sheath (PAS) for percutaneous nephrolithotomy.
• To compare the insertion time, blood loss, and cost of the PAS versus standard two-step access methods.
• To assess the potential of PAS to become a new standard for renal access.

Main Methods:

• A randomized study comparing two groups of patients undergoing PCNL.
• Group 1 (10 patients): Standard two-step access using a high-pressure balloon catheter.
• Group 2 (11 patients): Novel single-step Pathway Access Sheath (PAS).

Main Results:

• The PAS group demonstrated a statistically significant shorter average insertion time (3 minutes) compared to the high-pressure balloon catheter group (5 minutes, 42 seconds; P <0.01).
• Estimated blood loss and cost were comparable between the two techniques.
• The PAS's sheath flexibility was identified as a beneficial feature in certain cases.

Conclusions:

• The novel single-step Pathway Access Sheath (PAS) is a safe and effective device for percutaneous nephrolithotomy.
• PAS significantly reduces the time required for renal access.
• Further research is needed to determine if PAS will establish a new standard in renal access procedures.