US-guided trocar versus Seldinger technique for percutaneous cholecystostomy (TROSELC II trial)

Abstract

Objectives: The purpose of this study is to investigate the safety and effectiveness of the US-guided bedside trocar vs. the Seldinger technique for percutaneous cholecystostomy (PC) procedures.

Methods: This is a prospective single-center, randomized, controlled trial (RCT) comparing the trocar (group T; 50 patients [27 men]; mean [± SD] age, 74.16 ± 15.59 years) with the Seldinger technique for PC (group S; 50 patients [23 men]; mean [± SD] age, 80.78 ± 14.09 years) in consecutive patients undergoing the procedure in a bedside setting with the sole employment of US as a guidance modality. Primary outcomes consisted of technical success and complications associated with the procedure. Secondary outcome measures involved procedure duration, intra-/post-procedure pain evaluation, and clinical success.

Results: PC was technically successful for all 100 patients. Clinical success rates were similar between group T and S (94% vs. 92%, respectively; p = 0.34). Equal total procedure-related complications were noted in both groups (4% vs. 4%; p = 0.5). A minor bleeding event (bile mixed with blood) occurred in one patient (2%) in group T and one patient (2%) in group S; accidental catheter dislodgement in one patient (2%) from group T, and a small biloma in one patient (2%) from group S. No procedure-related deaths or major bleeding events were noted. PC was significantly faster in group T (1.41 ± 1.13 vs. 4.41 ± 2.68 min; p < 0.001). Mean pain score during PC was significantly lower in group T compared with group S at 12 h of follow-up (1.43 ± 1.45 vs. 3.36 ± 2.05; p < 0.01).

Conclusion: US-guided bedside trocar technique for PC was equally effective and safe as the Seldinger technique, but it was faster and simpler to perform and led to reduced pain following the procedure.

Keywords: Cholecystitis; Cholecystostomy; Complications; Gallbladder; Interventional ultrasonography.