Gallbladder Cryoablation for Calculous Cholecystitis Initially Treated with Percutaneous Drainage: A Prospective Trial in High-Risk Patients

Purpose: To prospectively evaluate the safety and effectiveness of gallbladder cryoablation in patients with calculous cholecystitis initially treated with percutaneous drainage. Materials and Methods: High–operative risk patients with calculous cholecystitis treated with cholecystostomy tube drainage underwent gallbladder cryoablation. The primary end points were safety, defined as the absence of procedure-related adverse events during the follow-up period, and clinical success, defined as the absence of symptoms after cholecystostomy tube removal. The secondary end point was imaging success, defined as gallbladder involution on computed tomography (CT) or magnetic resonance (MR) imaging. Results: Ten patients underwent gallbladder cryoablation. Mean age was 71 years (SD ± 10; range, 53–90 years). Mean American Society of Anesthesiologists score was 3 (SD ± 1; range, 2–4), and mean modified Frailty Index was 4 (SD ± 2; range, 1–6). Cholecystostomy tubes were in situ for a mean of 60 days (SD ± 26; range, 18–94 days) prior to cryoablation. Mean duration of clinical follow-up was 563 days (SD ± 152; range, 326–799 days) and of imaging follow-up was 368 days (SD ± 235; range, 66–792 days). One infection and 1 mortality occurred, both in patients with gallstones >20 mm in size, prior pseudomonas infection, and iceball volumes >150 cm³. Institutional review board (IRB) review concluded that the cause of the mortality was a medication allergy. Clinical and imaging success was achieved in 9 of 10 patients. Conclusions: Gallbladder cryoablation may be an effective treatment for high-operative risk patients with calculous cholecystitis initially treated with percutaneous drainage, with 90% clinical and imaging success. Optimization of patient selection is indicated, with particular reference to gallstone size and bacterial colonization.