Endoscopic balloon dilation compared to sphincterotomy (EDES) for extraction of bile duct stones: Preliminary results

J. A. DiSario, M. L. Freeman, D. J. Bjorkman, P. MacMathuna, B. Petersen, S. Sherman, G. Lehman, L. Hixson, P. Jaffe, F. Al-Kawas, J. Moore, M. Khandelwal

Research output: Contribution to journalArticle

56 Scopus citations

Abstract

Balloon dilation (BD) of the sphincter of Oddi for stone removal has been proposed as an alternative to sphincterotomy (ES). However, clinical outcomes data are limited. AIM: To determine the effectiveness of ED for stone removal. METHODS: A randomized, prospective, study involving 24 centers: 11 (46%) clinical practices and 13 (44%) academic centers. Patients who had or will have cholecystectomy, with bile duct stones ≤10 mm, ducts ≤15 mm, and without SOD. strictures or active pancreatitis were randomized to ED or ES. ED was to ≤8 mm and stones were removed with balloons, baskets and mechanical lithotripsy. ED subjects with incomplete stone extraction were crossed-over to ES. RESULTS: 177 subjects [118 (67%) women and 59 (33%) men] have been randomized and completed 30 day follow-up. ED ES X-over p * Subjects 85 (48%) 92 (52%) 5 (6%) Age, mean, yrs 46 ± 19 54 ± 19 58 ± 20 .015 ** Procedural success 80(94%) 92(100%) 5(100%) .861 ** Time, mean, min 51 ± 29 40 ± 18 75 ± 46 .011 ** Morbidity, overall 10(12%) 1(1%) 0 .006 1 Pancreatitis, mild 4 (5%) 0 0 .285 moderate 3 (4%) 1 (1%) 0 .517 1 severe 2 (3%) 0 0 .417 Cholangitis moderate 1 (1%) 0 0 .944 Mortality, pancreatitis 2 (3%) 0 0 .417 1 * Chi-square, α = 0.01, group sequential design; ** ED to ES 1 Includes protocol violations of no stones/probable SOD CONCLUSIONS: For stone extraction. ED compared to ES: 1) appears similarly effective, 2) may be associated with increased early morbidity, 3) requires longer procedures. ED should not be used in routine clinical practice until further data are available. Funded by: ACG, ASGE, Microvasive, ADHF.

Original languageEnglish (US)
Pages (from-to)AB129
JournalGastrointestinal endoscopy
Volume45
Issue number4
DOIs
StatePublished - Jan 1 1997
Externally publishedYes

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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    DiSario, J. A., Freeman, M. L., Bjorkman, D. J., MacMathuna, P., Petersen, B., Sherman, S., Lehman, G., Hixson, L., Jaffe, P., Al-Kawas, F., Moore, J., & Khandelwal, M. (1997). Endoscopic balloon dilation compared to sphincterotomy (EDES) for extraction of bile duct stones: Preliminary results. Gastrointestinal endoscopy, 45(4), AB129. https://doi.org/10.1016/S0016-5107(97)80418-X