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, Stuart Sherman, Glen Lehman, L. Hixson, P. Jaffe, F. Al-Kawas, J. Moore, M. Khandelwal

Research output: Contribution to journalArticle

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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)
JournalGastrointestinal Endoscopy
Volume45
Issue number4
StatePublished - 1997
Externally publishedYes

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Bile Ducts
Pancreatitis
Dilatation
Sphincter of Oddi
Morbidity
Cholangitis
Lithotripsy
Cholecystectomy
Pathologic Constriction
Prospective Studies
Mortality

ASJC Scopus subject areas

  • Gastroenterology

Cite this

DiSario, J. A., Freeman, M. L., Bjorkman, D. J., MacMathuna, P., Petersen, B., Sherman, S., ... Khandelwal, M. (1997). Endoscopic balloon dilation compared to sphincterotomy (EDES) for extraction of bile duct stones: Preliminary results. Gastrointestinal Endoscopy, 45(4).

Endoscopic balloon dilation compared to sphincterotomy (EDES) for extraction of bile duct stones : Preliminary results. / DiSario, J. A.; Freeman, M. L.; Bjorkman, D. J.; MacMathuna, P.; Petersen, B.; Sherman, Stuart; Lehman, Glen; Hixson, L.; Jaffe, P.; Al-Kawas, F.; Moore, J.; Khandelwal, M.

In: Gastrointestinal Endoscopy, Vol. 45, No. 4, 1997.

Research output: Contribution to journalArticle

DiSario, JA, Freeman, ML, Bjorkman, DJ, 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, vol. 45, no. 4.
DiSario, J. A. ; Freeman, M. L. ; Bjorkman, D. J. ; MacMathuna, P. ; Petersen, B. ; Sherman, Stuart ; Lehman, Glen ; Hixson, L. ; Jaffe, P. ; Al-Kawas, F. ; Moore, J. ; Khandelwal, M. / Endoscopic balloon dilation compared to sphincterotomy (EDES) for extraction of bile duct stones : Preliminary results. In: Gastrointestinal Endoscopy. 1997 ; Vol. 45, No. 4.
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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.",
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T1 - Endoscopic balloon dilation compared to sphincterotomy (EDES) for extraction of bile duct stones

T2 - Preliminary results

AU - DiSario, J. A.

AU - Freeman, M. L.

AU - Bjorkman, D. J.

AU - MacMathuna, P.

AU - Petersen, B.

AU - Sherman, Stuart

AU - Lehman, Glen

AU - Hixson, L.

AU - Jaffe, P.

AU - Al-Kawas, F.

AU - Moore, J.

AU - Khandelwal, M.

PY - 1997

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N2 - 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.

AB - 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.

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