AIM: To prospectively compare partially covered vs uncovered sphincterotome use on post-endoscopic biliary sphincterotomy (ES) hemorrhage and other complications. METHODS:All patients referred for therapeutic endoscopic retrograde cholangiopancreatography (ERCP) were randomly assigned to undergo ES either with a partially covered or an uncovered sphincterotome. Both patient and technical risk factors contributing to the development of post-ES bleeding were recorded and analyzed. The characteristics of bleeding was recorded during and after ES. Other complications were also compared. RESULTS:Three-hundred and eighty-seven patients were recruited in this study; 194 patients underwent ES with a partially covered sphincterotome and 193 with conventional uncovered sphincterotome. No statistical difference was noted in the baseline characteristics and risk factors for post-ES induced hemorrhage between the 2 groups. No significant difference in the incidence and pattern of visible bleeding rates was found between the 2 groups (immediate bleeding in 24 patients with the partially covered sphincterotome vs 19 patients with the uncovered sphincterotome, P = 0.418). Delayed bleeding was observed in 2 patients with a partially covered sphincterotome and in 1 patient with an uncovered sphincterotome (P = 0.62). No statistical difference was noted in the rate of other complications. CONCLUSION: The partially covered sphincterotome was not associated with a lower frequency of bleeding. Also, there was no difference in the incidence of other significant complications between the 2 types of sphincterotome.
RCT Entities:
AIM: To prospectively compare partially covered vs uncovered sphincterotome use on post-endoscopic biliary sphincterotomy (ES) hemorrhage and other complications. METHODS: All patients referred for therapeutic endoscopic retrograde cholangiopancreatography (ERCP) were randomly assigned to undergo ES either with a partially covered or an uncovered sphincterotome. Both patient and technical risk factors contributing to the development of post-ESbleeding were recorded and analyzed. The characteristics of bleeding was recorded during and after ES. Other complications were also compared. RESULTS: Three-hundred and eighty-seven patients were recruited in this study; 194 patients underwent ES with a partially covered sphincterotome and 193 with conventional uncovered sphincterotome. No statistical difference was noted in the baseline characteristics and risk factors for post-ES induced hemorrhage between the 2 groups. No significant difference in the incidence and pattern of visible bleeding rates was found between the 2 groups (immediate bleeding in 24 patients with the partially covered sphincterotome vs 19 patients with the uncovered sphincterotome, P = 0.418). Delayed bleeding was observed in 2 patients with a partially covered sphincterotome and in 1 patient with an uncovered sphincterotome (P = 0.62). No statistical difference was noted in the rate of other complications. CONCLUSION: The partially covered sphincterotome was not associated with a lower frequency of bleeding. Also, there was no difference in the incidence of other significant complications between the 2 types of sphincterotome.
Authors: P B Cotton; G Lehman; J Vennes; J E Geenen; R C Russell; W C Meyers; C Liguory; N Nickl Journal: Gastrointest Endosc Date: 1991 May-Jun Impact factor: 9.427
Authors: M L Freeman; D B Nelson; S Sherman; G B Haber; M E Herman; P J Dorsher; J P Moore; M B Fennerty; M E Ryan; M J Shaw; J D Lande; A M Pheley Journal: N Engl J Med Date: 1996-09-26 Impact factor: 91.245
Authors: C Mel Wilcox; Jerrold Canakis; Klaus E Mönkemüller; Anthony W Bondora; Wilma Geels Journal: Am J Gastroenterol Date: 2004-02 Impact factor: 10.864