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

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

Publication Date:
16 April 2020 (online)

© Georg Thieme Verlag KG
Stuttgart · New York