Randomized Controlled Trial for Paclitaxel-coated Balloon versus Plain Balloon Angioplasty in Dysfunctional Hemodialysis Vascular Access: 12-month Outcome from a Nonsponsored Trial.

BACKGROUND: Plain balloon angioplasty is regarded as the mainstay of treatment for failing vascular access with high success rate, but the poor treatment durability creates significant workload and increases patient morbidity. The study aims to compare target lesion primary patency rate at 12 months between paclitaxel-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for treatment of dysfunctional vascular access. METHODS: This nonsponsored-randomized trial enrolled 40 patients with dysfunctional dialysis access at a single center. Patients were randomized into In.Pact Admiral Paclitaxel DCB or POBA after lesion crossing regardless of lesion type. Patients are followed up under surveillance protocol. Patients, hemodialysis staff, and sonographer are blinded to the treatment arms. Twelve-month primary patency rate in both arms are evaluated. RESULTS: 40 patients were recruited since June 2016 and were allocated to the DCB or POBA group. The mean age is 58 and 57 years with comparable demographic parameters. The locations of target lesion were comparable in both groups (juxta and arteriovenous anastomosis, cannulation site, and fistula/graft), with similar mean target lesion stenosis 69.8 +/- 15.8% for DCB and 69.5 +/- 13.6% for POBA (P = 0.95), and the lesion length for DCB is 45.8 +/- 38.4 mm and 50.2 +/- 33.5 mm for POBA (P = 0.70). Patients in DCB performed significantly better in terms of primary patency at 6 months 85% versus 55% (P = 0.007). The superiority in primary patency in DCB group exists at 12 months 65% versus 30% (P = 0.007). CONCLUSIONS: Paclitaxel balloon angioplasty approach provides significant better primary patency in dysfunctional arteriovenous access at 12 months in our nonsponsored-randomized trial.

Prospective randomized comparative study of single incision laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy.

BACKGROUND: This study aimed to compare the outcomes of single-incision laparoscopic cholecystectomy (SILC) versus conventional 4-port laparoscopic cholecystectomy (LC). METHODS: From November 2009 to August 2010, 51 patients with symptomatic gallstone or gallbladder polyps were randomized to SILC (n = 24) or 4-port LC (n = 27). RESULTS: Mean surgical time (43.5 vs 46.5 min), median blood loss (1 vs 1 mL) and mean hospital stay (1.5 vs 1.8 d) were similar for both the SILC and 4-port LC group. There were no open conversions and no major complications. The mean total wound length of the SILC group was significantly shorter (1.76 vs 2.25 cm). The median visual analogue pain score at 6 hours after surgery was similar (4.5 vs 4.0) but the SILC group had a significantly worse pain score on day 7 (1 vs 0). There was no difference in time to resume usual activity (mean, 5.6 vs 5.0 d). The median cosmetic score of SILC was significantly higher than at 3 months after surgery (7 vs 6). CONCLUSIONS: SILC was feasible and safe for properly selected patients in experienced hands.