Randomized trial of 1-minute versus 5-minute endoscopic balloon dilation for extraction of bile duct stones

Wei Chih Liao, Ching Tai Lee, Chi Yang Chang, Joseph Leung, Jiann Hwa Chen, Ming Chang Tsai, Jaw Town Lin, Ming Shiang Wu, Hsiu Po Wang

Research output: Contribution to journalArticle

61 Citations (Scopus)

Abstract

Background Endoscopic papillary balloon dilation (EPBD) has a lower risk of hemorrhage than sphincterotomy and is easier to perform in altered/difficult anatomy. However, the sphincter of Oddi (SO) is only stretched but not cut after EPBD. Therefore, the biliary orifice is less opened, and failed stone extraction with EPBD alone occurs in up to 20% of patients. An uncut SO also may exacerbate pancreatic duct compression from edema after EPBD, and it increases the risk of pancreatitis. Objective To determine whether a longer duration for EPBD (5-minute vs conventional 1-minute) can further weaken the SO and reduce the rates of failed stone extraction and pancreatitis. Design Prospective, randomized trial. Setting Two tertiary-care referral centers. Patients This study involved 170 consecutive patients with common bile duct stones. Intervention EPBD for 1 minute (n = 86) or 5 minutes (n = 84). Main Outcome Measurements Failed stone extraction with EPBD alone and post-ERCP pancreatitis. Results Failed stone extraction with EPBD alone was less frequent with 5-minute EPBD (6 of 84, 7.1%) than with 1-minute EPBD (17 of 86, 19.8%), with a relative risk (RR) of 0.36 (P = .024). The risk of pancreatitis was also lower with 5-minute EPBD (4 of 84, 4.8%) than with 1-minute EPBD (13 of 86, 15.1%), with an RR of 0.32 (P = .038). Multivariable logistic regression analyses reaffirmed that 5-minute EPBD reduced the risk of failure with EPBD alone (odds ratio [OR] 0.19, P = .010) and pancreatitis (OR 0.28, P = .035). Limitations Endoscopists could not be blinded after the dilation durations were randomly assigned. Conclusion Compared with conventional 1-minute EPBD, 5-minute EPBD improves efficacy of stone extraction and reduces the risk of pancreatitis. (Clinical trial registration number: NCT00451581)

Original languageEnglish (US)
Pages (from-to)1154-1162
Number of pages9
JournalGastrointestinal Endoscopy
Volume72
Issue number6
DOIs
StatePublished - Dec 2010

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Bile Ducts
Dilatation
Pancreatitis
Sphincter of Oddi
Tertiary Care Centers
Odds Ratio
Endoscopic Retrograde Cholangiopancreatography
Pancreatic Ducts
Common Bile Duct

Keywords

  • Abbreviations
  • CBD
  • CI
  • Common bile duct
  • Confidence interval
  • Endoscopic papillary balloon dilation
  • Endoscopic papillary large balloon dilation
  • Endoscopic sphincterotomy
  • EPBD
  • EPLBD
  • EST
  • Odds ratio
  • OR
  • Relative risk
  • RR
  • SO
  • Sphincter of Oddi

ASJC Scopus subject areas

  • Gastroenterology
  • Radiology Nuclear Medicine and imaging

Cite this

Randomized trial of 1-minute versus 5-minute endoscopic balloon dilation for extraction of bile duct stones. / Liao, Wei Chih; Lee, Ching Tai; Chang, Chi Yang; Leung, Joseph; Chen, Jiann Hwa; Tsai, Ming Chang; Lin, Jaw Town; Wu, Ming Shiang; Wang, Hsiu Po.

In: Gastrointestinal Endoscopy, Vol. 72, No. 6, 12.2010, p. 1154-1162.

Research output: Contribution to journalArticle

Liao, Wei Chih ; Lee, Ching Tai ; Chang, Chi Yang ; Leung, Joseph ; Chen, Jiann Hwa ; Tsai, Ming Chang ; Lin, Jaw Town ; Wu, Ming Shiang ; Wang, Hsiu Po. / Randomized trial of 1-minute versus 5-minute endoscopic balloon dilation for extraction of bile duct stones. In: Gastrointestinal Endoscopy. 2010 ; Vol. 72, No. 6. pp. 1154-1162.
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T1 - Randomized trial of 1-minute versus 5-minute endoscopic balloon dilation for extraction of bile duct stones

AU - Liao, Wei Chih

AU - Lee, Ching Tai

AU - Chang, Chi Yang

AU - Leung, Joseph

AU - Chen, Jiann Hwa

AU - Tsai, Ming Chang

AU - Lin, Jaw Town

AU - Wu, Ming Shiang

AU - Wang, Hsiu Po

PY - 2010/12

Y1 - 2010/12

N2 - Background Endoscopic papillary balloon dilation (EPBD) has a lower risk of hemorrhage than sphincterotomy and is easier to perform in altered/difficult anatomy. However, the sphincter of Oddi (SO) is only stretched but not cut after EPBD. Therefore, the biliary orifice is less opened, and failed stone extraction with EPBD alone occurs in up to 20% of patients. An uncut SO also may exacerbate pancreatic duct compression from edema after EPBD, and it increases the risk of pancreatitis. Objective To determine whether a longer duration for EPBD (5-minute vs conventional 1-minute) can further weaken the SO and reduce the rates of failed stone extraction and pancreatitis. Design Prospective, randomized trial. Setting Two tertiary-care referral centers. Patients This study involved 170 consecutive patients with common bile duct stones. Intervention EPBD for 1 minute (n = 86) or 5 minutes (n = 84). Main Outcome Measurements Failed stone extraction with EPBD alone and post-ERCP pancreatitis. Results Failed stone extraction with EPBD alone was less frequent with 5-minute EPBD (6 of 84, 7.1%) than with 1-minute EPBD (17 of 86, 19.8%), with a relative risk (RR) of 0.36 (P = .024). The risk of pancreatitis was also lower with 5-minute EPBD (4 of 84, 4.8%) than with 1-minute EPBD (13 of 86, 15.1%), with an RR of 0.32 (P = .038). Multivariable logistic regression analyses reaffirmed that 5-minute EPBD reduced the risk of failure with EPBD alone (odds ratio [OR] 0.19, P = .010) and pancreatitis (OR 0.28, P = .035). Limitations Endoscopists could not be blinded after the dilation durations were randomly assigned. Conclusion Compared with conventional 1-minute EPBD, 5-minute EPBD improves efficacy of stone extraction and reduces the risk of pancreatitis. (Clinical trial registration number: NCT00451581)

AB - Background Endoscopic papillary balloon dilation (EPBD) has a lower risk of hemorrhage than sphincterotomy and is easier to perform in altered/difficult anatomy. However, the sphincter of Oddi (SO) is only stretched but not cut after EPBD. Therefore, the biliary orifice is less opened, and failed stone extraction with EPBD alone occurs in up to 20% of patients. An uncut SO also may exacerbate pancreatic duct compression from edema after EPBD, and it increases the risk of pancreatitis. Objective To determine whether a longer duration for EPBD (5-minute vs conventional 1-minute) can further weaken the SO and reduce the rates of failed stone extraction and pancreatitis. Design Prospective, randomized trial. Setting Two tertiary-care referral centers. Patients This study involved 170 consecutive patients with common bile duct stones. Intervention EPBD for 1 minute (n = 86) or 5 minutes (n = 84). Main Outcome Measurements Failed stone extraction with EPBD alone and post-ERCP pancreatitis. Results Failed stone extraction with EPBD alone was less frequent with 5-minute EPBD (6 of 84, 7.1%) than with 1-minute EPBD (17 of 86, 19.8%), with a relative risk (RR) of 0.36 (P = .024). The risk of pancreatitis was also lower with 5-minute EPBD (4 of 84, 4.8%) than with 1-minute EPBD (13 of 86, 15.1%), with an RR of 0.32 (P = .038). Multivariable logistic regression analyses reaffirmed that 5-minute EPBD reduced the risk of failure with EPBD alone (odds ratio [OR] 0.19, P = .010) and pancreatitis (OR 0.28, P = .035). Limitations Endoscopists could not be blinded after the dilation durations were randomly assigned. Conclusion Compared with conventional 1-minute EPBD, 5-minute EPBD improves efficacy of stone extraction and reduces the risk of pancreatitis. (Clinical trial registration number: NCT00451581)

KW - Abbreviations

KW - CBD

KW - CI

KW - Common bile duct

KW - Confidence interval

KW - Endoscopic papillary balloon dilation

KW - Endoscopic papillary large balloon dilation

KW - Endoscopic sphincterotomy

KW - EPBD

KW - EPLBD

KW - EST

KW - Odds ratio

KW - OR

KW - Relative risk

KW - RR

KW - SO

KW - Sphincter of Oddi

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