Balloon catheter versus basket catheter for endoscopic bile duct stone extraction: a multicenter randomized trial

Hirotoshi Ishiwatari; Hiroshi Kawakami; Hiroyuki Hisai; Kei Yane; Manabu Onodera; Kazunori Eto; Shin Haba; Toshinori Okuda; Hideyuki Ihara; Takehiro Kukitsu; Ryusuke Matsumoto; Keisuke Kitaoka; Tomoko Sonoda; Tsuyoshi Hayashi; for the Hokkaido Interventional EUS/ERCP Study (HONEST) Group

doi:10.1055/s-0035-1569573

Endoscopy, Table of Contents

Endoscopy 2016; 48(04): 350-357
DOI: 10.1055/s-0035-1569573

Original article

Balloon catheter versus basket catheter for endoscopic bile duct stone extraction: a multicenter randomized trial

Authors

Hirotoshi Ishiwatari

¹Department of Medical Oncology and Hematology, Sapporo Medical University, Sapporo, Japan
Hiroshi Kawakami

²Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan
Hiroyuki Hisai

³Department of Gastroenterology, Japanese Red Cross Date General Hospital, Date, Japan
Kei Yane

⁴Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan
Manabu Onodera

⁵Department of Gastroenterology, Abashiri-Kosei General Hospital, Abashiri, Japan
Kazunori Eto

⁶Department of Gastroenterology, Tomakomai City Hospital, Tomakomai, Japan
Shin Haba

⁷Department of Gastroenterology, NTT East Japan Sapporo Hospital, Sapporo, Japan
Toshinori Okuda

⁸Department of Gastroenterology, Oji General Hospital, Tomakomai, Japan
Hideyuki Ihara

⁹Department of Gastroenterology, KKR Sapporo Medical Center Tonan Hospital, Sapporo, Japan
Takehiro Kukitsu

¹⁰Department of Gastroenterology, Rumoi City Hospital, Rumoi, Japan
Ryusuke Matsumoto

¹¹Department of Gastroenterology, Obihiro-Kosei General Hospital, Obihiro, Japan
Keisuke Kitaoka

¹²Department of Gastroenterology, Otaru Ekisaikai Hospital, Otaru, Japan
Tomoko Sonoda

¹³Department of Public Health, Sapporo Medical University School of Medicine, Sapporo, Japan
Tsuyoshi Hayashi

¹Department of Medical Oncology and Hematology, Sapporo Medical University, Sapporo, Japan

for the Hokkaido Interventional EUS/ERCP Study (HONEST) Group

Abstract

Background and study aims: Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent. We therefore conducted a multicenter prospective randomized trial to compare catheter performance.

Patients and methods: We enrolled patients with a BDS diameter ≤ 10 mm and common bile duct diameter ≤ 15 mm. Participants were randomly assigned to groups that were treated with basket or balloon catheters between October 2013 and September 2014. The primary endpoint was the rate of complete clearance of the duct; the secondary endpoints were the rate and time to complete clearance in one endoscopic session.

Results: We initially enrolled 172 consecutive patients; 14 were excluded after randomization. The complete clearance rates were 92.3 % (72/78) in the balloon group and 80.0 % (64 /80) in the basket group. The difference in the rates between the two groups was 12.3 percentage points, indicating non-inferiority of the balloon method (non-inferiority limit −10 %; P < 0.001 for non-inferiority). Moreover, the balloon was superior to the basket (P = 0.037). The rate of complete clearance in one endoscopic session was 97.4 % using the balloon and 97.5 % using the basket (P = 1.00). The median times to complete clearance in one endoscopic session were 6.0 minutes (1 – 30) and 7.8 minutes (1 – 37) in the balloon and basket groups, respectively (P = 0.15).

Conclusions: For extraction of BDSs ≤ 10 mm, complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter.

University Hospital Medical Information Network Trials Registry: UMIN000011887.

Full Text

References

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