Dong-Won Ahn1,2, Sang Hyub Lee1,3, Woo Hyun Paik1,3,4, Byeong Jun Song5, Jin Myung Park6, Jaihwan Kim1,7, Ji Bong Jeong1,2, Jin-Hyeok Hwang1,7, Ji Kon Ryu1,3, Yong-Tae Kim1,3. 1. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea. 2. Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea. 3. Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. 4. Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea. 5. Department of Internal Medicine, Seonam University Myongji Hospital, Goyang, Korea. 6. Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, Korea. 7. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Abstract
OBJECTIVES: In clinical practice, recurrent cholangitis due to residual common bile duct (CBD) stone occurs frequently even after endoscopic stone removal. This study aimed to determine whether preventive saline irrigation of the bile duct (PSIB) after endoscopic removal of CBD stones would decrease the residual CBD stones. METHODS: In this multicenter, prospective, randomized study, patients who receivedendoscopic retrograde cholangiopancreatographyfor removal of CBD stone were randomized to either receiving PSIB after stone removal (PSIB group) or not receiving PSIB (non-PSIB group). Patients were prospectively followed up and the presence of residual CBD stones was evaluated within 6 months after endoscopic stone removal. RESULTS: A total of 148 patients were enrolled and completed follow-up (73 in PSIB group and 75 in non-PSIB group). The two groups were similar with regard to baseline characteristics. Residual CBD stones were detected in 22 patients (14.9%). The incidences of residual CBD stones were 6.8% in PSIB group and 22.7% in non-PSIB group (P=0.010). Multivariate analysis revealed that the performance of PSIB and the presence of only a single-CBD stone were the significant factors for the decrease of the occurrence of the residual CBD stones. Although, procedure time was slightly longer in PSIB group (22.0 vs 19.2 min, P=0.037), no significant difference was observed in the procedure-related complications between the two groups. CONCLUSIONS: PSIB could reduce the residual CBD stones without increasing complications. Considering the efficacy and safety, routine PSIB after endoscopic CBD stone removal seems to be preferred (ClinicalTrials.gov identifier: NCT01425177).
RCT Entities:
OBJECTIVES: In clinical practice, recurrent cholangitis due to residual common bile duct (CBD) stone occurs frequently even after endoscopic stone removal. This study aimed to determine whether preventive saline irrigation of the bile duct (PSIB) after endoscopic removal of CBD stones would decrease the residual CBD stones. METHODS: In this multicenter, prospective, randomized study, patients who received endoscopic retrograde cholangiopancreatography for removal of CBD stone were randomized to either receiving PSIB after stone removal (PSIB group) or not receiving PSIB (non-PSIB group). Patients were prospectively followed up and the presence of residual CBD stones was evaluated within 6 months after endoscopic stone removal. RESULTS: A total of 148 patients were enrolled and completed follow-up (73 in PSIB group and 75 in non-PSIB group). The two groups were similar with regard to baseline characteristics. Residual CBD stones were detected in 22 patients (14.9%). The incidences of residual CBD stones were 6.8% in PSIB group and 22.7% in non-PSIB group (P=0.010). Multivariate analysis revealed that the performance of PSIB and the presence of only a single-CBD stone were the significant factors for the decrease of the occurrence of the residual CBD stones. Although, procedure time was slightly longer in PSIB group (22.0 vs 19.2 min, P=0.037), no significant difference was observed in the procedure-related complications between the two groups. CONCLUSIONS: PSIB could reduce the residual CBD stones without increasing complications. Considering the efficacy and safety, routine PSIB after endoscopic CBD stone removal seems to be preferred (ClinicalTrials.gov identifier: NCT01425177).
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