Single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis: a multicenter, non-randomized, open-label and exploratory clinical trial.
BACKGROUND
Two-stage treatment involving stone removal after drainage is recommended for mild to moderate acute cholangitis associated with choledocholithiasis. However, single-stage treatment has some advantages. We aimed to assess the efficacy and safety of single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis.


METHODS
A multicenter, non-randomized, open-label, exploratory clinical trial was performed in 12 institutions. A total of 50 patients with a naïve papilla and a body temperature ≥37 °C who were diagnosed with mild to moderate cholangitis associated with choledocholithiasis were enrolled between August 2012 and February 2014.


RESULTS
Of the 50 patients, 15 had mild cholangitis and 35 had moderate cholangitis. The median number of common bile duct stones was 2 (range, 1-8), and the median diameter of the common bile duct stones was 7.5 mm (range, 1-18). The cure rate of acute cholangitis within 4 days after single-stage treatment was 90% (45/50) based on a body temperature <37 °C for ≥24 h. The incidence of complications was 10% (5/50).


CONCLUSIONS
Single-stage endoscopic treatment may be effective and safe for mild to moderate acute cholangitis associated with choledocholithiasis (clinical trial registration number: UMIN000008494).
Department of Gastroenterology, Tomakomai City Hospital, Tomakomai, Hokkaido, Japan.
Kazunori
K
Eto
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan. hiropon@med.hokudai.ac.jp.
Hiroshi
H
Kawakami
Department of Gastroenterology, NTT East Japan Sapporo Hospital, Sapporo, Hokkaido, Japan.
Shin
S
Haba
Department of Gastroenterology, Municipal Hakodate Hospital, Hakodate, Hokkaido, Japan.
Hiroaki
H
Yamato
Department of Gastroenterology, Oji General Hospital, Tomakomai, Hokkaido, Japan.
Toshinori
T
Okuda
Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Hokkaido, Japan.
Kei
K
Yane
Department of Medical Oncology and Hematology, Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan.
Tsuyoshi
T
Hayashi
Department of Gastroenterology, Japanese Red Cross Kitami Hospital, Kitami, Japan.
Nobuyuki
N
Ehira
Department of Internal Medicine and Gastroenterology, Abashiri-Kosei General Hospital, Abashiri, Hokkaido, Japan.
Manabu
M
Onodera
Third Department of Internal Medicine, Obihiro Kosei General Hospital, Obihiro, Hokkaido, Japan.
Ryusuke
R
Matsumoto
Gastroenterology Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Hokkaido, Japan.
Yu
Y
Matsubara
Department of Gastroenterology, Sapporo Hokushin Hospital, Sapporo, Hokkaido, Japan.
Tomofumi
T
Takagi
Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan.
Naoya
N
Sakamoto
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods; D002761:Cholangitis / Q000150:complications / Q000601:surgery*; D042883:Choledocholithiasis / Q000150:complications / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016717:Sphincterotomy, Endoscopic / Q000379:methods*; D016896:Treatment Outcome
Acute cholangitis; Bile duct stone; Biliary drainage; Endoscopic sphincterotomy; Single-stage treatment