Endoscopy 2019; 51(02): 125-132
DOI: 10.1055/a-0639-5147
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Comparison of endoscopic papillary large balloon dilation with or without endoscopic sphincterotomy for the treatment of large bile duct stones

Jin-Seok Park*
1  Division of Gastroenterology, Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea
,
Seok Jeong
1  Division of Gastroenterology, Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea
,
Dong Ki Lee
2  Yonsei University College of Medicine, Seoul, South Korea
,
Sung Ill Jang
2  Yonsei University College of Medicine, Seoul, South Korea
,
Tae Hoon Lee
3  Soon Chun Hyang University School of Medicine, Cheonan Hospital, Cheonan, South Korea
,
Sang-Heum Park
3  Soon Chun Hyang University School of Medicine, Cheonan Hospital, Cheonan, South Korea
,
Jae Chul Hwang
4  Ajou University School of Medicine, Suwon, South Korea
,
Jin Hong Kim
4  Ajou University School of Medicine, Suwon, South Korea
,
Byoung Moo Yoo
4  Ajou University School of Medicine, Suwon, South Korea
,
Shin Goo Park
5  Occupational and Environmental Medicine, Inha University School of Medicine, Incheon, South Korea
,
Don Haeng Lee*
1  Division of Gastroenterology, Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea
› Author Affiliations
TRIAL REGISTRATION: Multi-center, prospective, randomized controlled trial KCT0001564at https://cris.nih.go.kr/cris
Further Information

Publication History

submitted 08 January 2018

accepted after revision 17 May 2018

Publication Date:
03 July 2018 (eFirst)

Abstract

Background Endoscopic papillary large balloon dilation (EPLBD) without prior endoscopic sphincterotomy (EST) produces excellent outcomes for the treatment of large common bile duct (CBD) stones. However, it remains unclear how the outcomes of EPLBD alone compare with those of EPLBD with EST. In this study, we assessed the safety and therapeutic outcomes of EPLBD with vs. without EST for the removal of large bile duct stones.

Methods This prospective, multicenter study was conducted on 200 patients with bile duct stones of ≥ 10 mm in diameter. Patients were randomly assigned to an EPLBD alone group (n = 100) or an EPLBD with EST group (n = 100). These two groups were compared with respect to overall procedure-related adverse events, overall stone removal success rate, number of endoscopic sessions required for complete stone removal, need for mechanical lithotripsy, and total procedure time.

Results The incidence of adverse events was not significantly different between the groups (EPLBD alone vs. EPLBD with EST: overall adverse events 6 % vs. 4 %, P = 0.75; pancreatitis 1 % vs. 3 %, P = 0.62). Overall success (P = 0.35), initial success (P = 0.28), and the need for mechanical lithotripsy (P = 0.39) were also similar between groups. Median total procedure time tended to be greater in the EPLBD alone group (20.5 minutes) than in the EPLBD with EST group (18 minutes; P = 0.08).

Conclusion The therapeutic outcomes and adverse events of EPLBD alone for the removal of large bile duct stones were comparable to those of EPLBD with EST.

* These authors contributed equally.