Download PDF
Endoscopy 2020; 52(09): 736-744
DOI: 10.1055/a-1145-3377
Original article

Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial

Hirofumi Kogure
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Shuhei Kawahata
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
2   Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan
,
Tsuyoshi Mukai
3   Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan
,
Shinpei Doi
4   First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan
5   Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa, Japan
,
Takuji Iwashita
4   First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan
,
Tesshin Ban
6   Department of Gastroenterology, Nagoya Daini Red Cross Hospital, Nagoya, Japan
7   Department of Gastroenterology and Hepatology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
,
Yukiko Ito
8   Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan
,
Hiroshi Kawakami
2   Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan
7   Department of Gastroenterology and Hepatology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
,
Tsuyoshi Hayashi
9   Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan
,
Naoki Sasahira
10   Department of Gastroenterology, Tokyo Takanawa Hospital of Japan Community Health-care Organization, Tokyo, Japan
,
Kensuke Kubota
11   Division of Gastroenterology, Yokohama City University, Graduate School of Medicine, Yokohama, Japan
,
Osamu Togawa
12   Department of Gastroenterology, Kanto Central Hospital, Tokyo, Japan
,
Hironari Kato
13   Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan
,
Yoshinobu Okabe
14   Division of Gastroenterology, Department of Medicine, Kurume University of Medicine, Kurume, Japan
,
Saburo Matsubara
15   Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan
16   Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama, Japan
,
Hiroshi Yagioka
15   Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan
17   Department of Gastroenterology, JR Tokyo General Hospital, Tokyo, Japan
,
Tomotaka Saito
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
17   Department of Gastroenterology, JR Tokyo General Hospital, Tokyo, Japan
,
Yousuke Nakai
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Hiroyuki Isayama
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
18   Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan
› Author Affiliations
› Further Information
Also available at
   Permissions and Reprints

See also:

Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trialEndoscopy 2021; 53(02): 212-212
DOI: 10.1055/a-1288-0772

See also:

The role of endoscopic papillary large balloon dilatation without sphincterotomyEndoscopy 2021; 53(05): 559-559
DOI: 10.1055/a-1308-2160

Abstract

Background Endoscopic papillary large balloon dilation (EPLBD) has been increasingly used for the management of large common bile duct (CBD) stones. Although EPLBD is often preceded by endoscopic sphincterotomy (EST), EPLBD alone without EST has been increasingly reported as an alternative to EST for large CBD stones.

Methods This multicenter randomized trial was conducted at 19 Japanese institutions to compare the efficacy and safety of EPLBD alone versus EST for the removal of large (≥ 10 mm) CBD stones. The primary end point was complete stone removal in a single session. The secondary end points included: overall complete stone removal, lithotripsy use, procedure time, adverse events, and cost.

Results 171 patients with large CBD stones were included in the analysis. The rate of single-session complete stone removal was significantly higher in the EPLBD-alone group than in the EST group (90.7 % vs. 78.8 %; P = 0.04). Lithotripsy use was significantly less frequent in the EPLBD group than in the EST group (30.2 % vs. 48.2 %; P = 0.02). The rates of early adverse events were comparable between the two groups: rates of overall adverse events were 9.3 % vs. 9.4 % and of pancreatitis were 4.7 % vs. 5.9 % in the EPLBD and EST groups, respectively. The procedure costs were $1442 vs. $1661 in the EPLBD and EST groups, respectively (P = 0.12).

Conclusion EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events.



Publication History

Received: 19 May 2019

Accepted: 10 March 2020

Article published online:
16 April 2020

© Georg Thieme Verlag KG
Stuttgart · New York

Refers to:

Endoscopic papillary large balloon dilation: more questions than answersEndoscopy 2020; 52(09): 745-746
DOI: 10.1055/a-1189-3035

Letter to this article:

Reply to Phillpotts and WebsterEndoscopy 2021; 53(05): 560-560
DOI: 10.1055/a-1308-2228

 

  • References

  • 1 Cotton PB, Geenen JE, Sherman S. et al. Endoscopic sphincterotomy for stones by experts is safe, even in younger patients with normal ducts. Ann Surg 1998; 227: 201-204
    CrossrefPubMedSearch in Google Scholar
  • 2 Staritz M, Ewe K, Meyer zum Buschenfelde KH. Endoscopic papillary dilation (EPD) for the treatment of common bile duct stones and papillary stenosis. Endoscopy 1983; 15 (Suppl. 01) 197-198
    Thieme ConnectPubMedSearch in Google Scholar
  • 3 Komatsu Y, Kawabe T, Toda N. et al. Endoscopic papillary balloon dilation for the management of common bile duct stones: experience of 226 cases. Endoscopy 1998; 30: 12-17
    Thieme ConnectPubMedSearch in Google Scholar
  • 4 Tsujino T, Kawabe T, Komatsu Y. et al. Endoscopic papillary balloon dilation for bile duct stone: immediate and long-term outcomes in 1000 patients. Clin Gastroenterol Hepatol 2007; 5: 130-137
    CrossrefPubMedSearch in Google Scholar
  • 5 Fujita N, Maguchi H, Komatsu Y. et al. Endoscopic sphincterotomy and endoscopic papillary balloon dilatation for bile duct stones: A prospective randomized controlled multicenter trial. Gastrointest Endosc 2003; 57: 151-155
    CrossrefPubMedSearch in Google Scholar
  • 6 Vlavianos P, Chopra K, Mandalia S. et al. Endoscopic balloon dilatation versus endoscopic sphincterotomy for the removal of bile duct stones: a prospective randomised trial. Gut 2003; 52: 1165-1169
    CrossrefPubMedSearch in Google Scholar
  • 7 Disario JA, Freeman ML, Bjorkman DJ. et al. Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones. Gastroenterology 2004; 127: 1291-1299
    CrossrefPubMedSearch in Google Scholar
  • 8 Kawabe T, Komatsu Y, Tada M. et al. Endoscopic papillary balloon dilation in cirrhotic patients: removal of common bile duct stones without sphincterotomy. Endoscopy 1996; 28: 694-698
    Thieme ConnectPubMedSearch in Google Scholar
  • 9 Park DH, Kim M-H, Lee SK. et al. Endoscopic sphincterotomy vs. endoscopic papillary balloon dilation for choledocholithiasis in patients with liver cirrhosis and coagulopathy. Gastrointestinal Endoscopy 2004; 60: 180-185
    CrossrefPubMedSearch in Google Scholar
  • 10 Sasahira N, Tada M, Yoshida H. et al. Extrahepatic biliary obstruction after percutaneous tumour ablation for hepatocellular carcinoma: aetiology and successful treatment with endoscopic papillary balloon dilatation. Gut 2005; 54: 698-702
    CrossrefPubMedSearch in Google Scholar
  • 11 Takahara N, Isayama H, Sasaki T. et al. Endoscopic papillary balloon dilation for bile duct stones in patients on hemodialysis. J Gastroenterol 2012; 47: 918-923
    CrossrefPubMedSearch in Google Scholar
  • 12 Yasuda I, Tomita E, Enya M. et al. Can endoscopic papillary balloon dilation really preserve sphincter of Oddi function?. Gut 2001; 49: 686-691
    CrossrefPubMedSearch in Google Scholar
  • 13 Isayama H, Komatsu Y, Inoue Y. et al. Preserved function of the Oddi sphincter after endoscopic papillary balloon dilation. Hepatogastroenterology 2003; 50: 1787-1791
    PubMedSearch in Google Scholar
  • 14 Kogure H, Tsujino T, Isayama H. et al. Short- and long-term outcomes of endoscopic papillary large balloon dilation with or without sphincterotomy for removal of large bile duct stones. Scand J Gastroenterol 2014; 49: 121-128
    CrossrefPubMedSearch in Google Scholar
  • 15 Kim TH, Kim JH, Seo DW. et al. International consensus guidelines for endoscopic papillary large-balloon dilation. Gastrointest Endosc 2016; 83: 37-47
    CrossrefPubMedSearch in Google Scholar
  • 16 Doshi B, Yasuda I, Ryozawa S. et al. Current endoscopic strategies for managing large bile duct stones. Dig Endosc 2018; 30 (Suppl. 01) 59-66
    CrossrefPubMedSearch in Google Scholar
  • 17 Itoi T, Ryozawa S, Katanuma A. et al. Japan Gastroenterological Endoscopy Society guidelines for endoscopic papillary large balloon dilation. Dig Endosc 2018; 30: 293-309
    CrossrefPubMedSearch in Google Scholar
  • 18 Park SJ, Kim JH, Hwang JC. et al. Factors predictive of adverse events following endoscopic papillary large balloon dilation: results from a multicenter series. Dig Dis Sci 2013; 58: 1100-1109
    CrossrefPubMedSearch in Google Scholar
  • 19 Okuno M, Iwashita T, Yoshida K. et al. Significance of endoscopic sphincterotomy preceding endoscopic papillary large balloon dilation in the management of bile duct stones. Dig Dis Sci 2016; 61: 597-602
    CrossrefPubMedSearch in Google Scholar
  • 20 Ikarashi S, Katanuma A, Kin T. et al. Factors associated with delayed hemorrhage after endoscopic sphincterotomy: Japanese large single-center experience. J Gastroenterol 2017; 52: 1258-1265
    CrossrefPubMedSearch in Google Scholar
  • 21 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
    CrossrefPubMedSearch in Google Scholar
  • 22 Heo JH, Kang DH, Jung HJ. et al. Endoscopic sphincterotomy plus large-balloon dilation versus endoscopic sphincterotomy for removal of bile-duct stones. Gastrointest Endosc 2007; 66: 720-726
    CrossrefPubMedSearch in Google Scholar
  • 23 Stefanidis G, Viazis N, Pleskow D. et al. Large balloon dilation vs. mechanical lithotripsy for the management of large bile duct stones: a prospective randomized study. Am J Gastroenterol 2011; 106: 278-285
    CrossrefPubMedSearch in Google Scholar
  • 24 Oh MJ, Kim TN. Prospective comparative study of endoscopic papillary large balloon dilation and endoscopic sphincterotomy for removal of large bile duct stones in patients above 45 years of age. Scand J Gastroenterol 2012; 47: 1071-1077
    CrossrefPubMedSearch in Google Scholar
  • 25 Hwang JC, Kim JH, Lim SG. et al. Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones. BMC Gastroenterol 2013; 13: 15
    CrossrefPubMedSearch in Google Scholar
  • 26 Teoh AY, Cheung FK, Hu B. et al. Randomized trial of endoscopic sphincterotomy with balloon dilation versus endoscopic sphincterotomy alone for removal of bile duct stones. Gastroenterology 2013; 144: 341-345
    CrossrefPubMedSearch in Google Scholar
  • 27 Guo Y, Lei S, Gong W. et al. A preliminary comparison of endoscopic sphincterotomy, endoscopic papillary large balloon dilation, and combination of the two in endoscopic choledocholithiasis treatment. Med Sci Monit 2015; 21: 2607-2612
    CrossrefPubMedSearch in Google Scholar
  • 28 Karsenti D, Coron E, Vanbiervliet G. et al. Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study. Endoscopy 2017; 49: 968-976
    Thieme ConnectPubMedSearch in Google Scholar
  • 29 Omar MA, Abdelshafy M, Ahmed MY. et al. Endoscopic papillary large balloon dilation versus endoscopic sphincterotomy for retrieval of large choledocholithiasis: a prospective randomized trial. J Laparoendosc Adv Surg Tech A 2017; 27: 704-709
    CrossrefPubMedSearch in Google Scholar
  • 30 Cheon YK, Lee TY, Kim SN. et al. Impact of endoscopic papillary large-balloon dilation on sphincter of Oddi function: a prospective randomized study. Gastrointest Endosc 2017; 85: 782-790
    CrossrefPubMedSearch in Google Scholar
  • 31 Park JS, Jeong S, Lee DK. et al. Comparison of endoscopic papillary large balloon dilation with or without endoscopic sphincterotomy for the treatment of large bile duct stones. Endoscopy 2019; 51: 125-132
    Thieme ConnectPubMedSearch in Google Scholar
  • 32 Nakai Y, Isayama H, Sasahira N. et al. Risk factors for post-ERCP pancreatitis in wire-guided cannulation for therapeutic biliary ERCP. Gastrointest Endosc 2015; 81: 119-126
    CrossrefPubMedSearch in Google Scholar
  • 33 Liao WC, Tu YK, Wu MS. et al. Balloon dilation with adequate duration is safer than sphincterotomy for extracting bile duct stones: a systematic review and meta-analyses. Clin Gastroenterol Hepatol 2012; 10: 1101-1109
    CrossrefPubMedSearch in Google Scholar
  • 34 Meng W, Leung JW, Zhang K. et al. Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: a multicentre, single-blinded, randomised controlled trial. Lancet Gastroenterol Hepatol 2019; 4: 425-434
    CrossrefPubMedSearch in Google Scholar
  • 35 Maruta A, Iwashita T, Uemura S. et al. Comparison of late adverse events after endoscopic sphincterotomy versus endoscopic papillary large balloon dilation for common bile duct stones: A propensity score-based cohort analysis. Dig Endosc 2018; 30: 493-500
    CrossrefPubMedSearch in Google Scholar
  • 36 Hakuta R, Kawahata S, Kogure H. et al. Endoscopic papillary large balloon dilation and endoscopic papillary balloon dilation both without sphincterotomy for removal of large bile duct stones: A propensity-matched analysis. Dig Endosc 2019; 31: 59-68
    CrossrefPubMedSearch in Google Scholar