title: Factors predictive of adverse events following endoscopic papillary large balloon dilation: results from a multicenter series.
abstract: BACKGROUND
  Lack of established guidelines for endoscopic papillary large balloon dilation (EPLBD) may be a reason for aversion of its use in removal of large common bile duct (CBD) stones.
  
  
  OBJECTIVE
  We sought to identify factors predictive of adverse events (AEs) following EPLBD.
  
  
  METHODS
  This multicenter retrospective study investigated 946 consecutive patients who underwent attempted removal of CBD stones ≥10 mm in size using EPLBD (balloon size 12-20 mm) with or without endoscopic sphincterotomy (EST) at 12 academic medical centers in Korea and Japan.
  
  
  RESULTS
  Ninety-five (10.0 %) patients exhibited AEs including bleeding in 56, pancreatitis in 24, perforation in nine, and cholangitis in six; 90 (94.7 %) of these were classified as mild or moderate in severity. There were four deaths, three as a result of perforation and one due to delayed massive bleeding. Causative factors identified in fatal cases were full-EST and continued balloon inflation despite a persistent waist seen fluoroscopically. Multivariate analyses showed that cirrhosis (OR 8.03, p = 0.003), length of EST (full-EST: OR 6.22, p < 0.001) and stone size (≥16 mm: OR 4.00, p < 0.001) were associated with increased bleeding, and distal CBD stricture (OR 17.08, p < 0.001) was an independent predictor for perforation. On the other hand, balloon size was associated with deceased pancreatitis (≥14 mm: OR 0.27, p = 0.015).
  
  
  CONCLUSIONS
  EPLBD appears to be a safe and effective therapeutic approach for retrieval of large stones in patients without distal CBD strictures and when performed without full-EST.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonjuro Gangnam-gu, Seoul 135-720, Korea.
authors.forename: Soo Jung
authors.initials: SJ
authors.lastname: Park
authors.forename: Jin Hong
authors.initials: JH
authors.lastname: Kim
authors.forename: Jae Chul
authors.initials: JC
authors.lastname: Hwang
authors.forename: Ho Gak
authors.initials: HG
authors.lastname: Kim
authors.forename: Don Haeng
authors.initials: DH
authors.lastname: Lee
authors.forename: Seok
authors.initials: S
authors.lastname: Jeong
authors.forename: Sang-Woo
authors.initials: SW
authors.lastname: Cha
authors.forename: Young Deok
authors.initials: YD
authors.lastname: Cho
authors.forename: Hong Ja
authors.initials: HJ
authors.lastname: Kim
authors.forename: Jong Hyeok
authors.initials: JH
authors.lastname: Kim
authors.forename: Jong Ho
authors.initials: JH
authors.lastname: Moon
authors.forename: Sang-Heum
authors.initials: SH
authors.lastname: Park
authors.forename: Takao
authors.initials: T
authors.lastname: Itoi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kogure
authors.forename: Se Joon
authors.initials: SJ
authors.lastname: Lee
authors.forename: Kyo Tae
authors.initials: KT
authors.lastname: Jung
authors.forename: Hye Sun
authors.initials: HS
authors.lastname: Lee
authors.forename: Todd H
authors.initials: TH
authors.lastname: Baron
authors.forename: Dong Ki
authors.initials: DK
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000401:mortality; D017809:Fatal Outcome; D005260:Female; D042882:Gallstones / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D056910:Republic of Korea / Q000453:epidemiology; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult