Open AccessEndoscopic ultrasound-guided biliary drainage for malignant biliary obstruction with surgically altered anatomy: a multicenter prospective registration study
Author(s) -
Kosuke Minaga,
Mamoru Takenaka,
Takeshi Ogura,
Takashi Tamura,
Taira Kuroda,
Toyoma Kaku,
Yoshito Uenoyama,
Chishio Noguchi,
Hidefumi Nishikiori,
Hisao Imai,
Ryota Sagami,
Nao Fujimori,
Kazuhide Higuchi,
Masatoshi Kudo,
Yasutaka Chiba,
Masayuki Kitano
Publication year - 2020
Publication title -
therapeutic advances in gastroenterology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.278
H-Index - 51
eISSN - 1756-2848
pISSN - 1756-283X
DOI - 10.1177/1756284820930964
Subject(s) - medicine , endoscopic ultrasound , clinical endpoint , stent , surgery , prospective cohort study , confidence interval , radiology , randomized controlled trial
Background: Endoscopic treatment for malignant biliary obstruction (MBO) in patients bearing surgically altered anatomy (SAA) is not well-established. Although endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as a new treatment option for MBO, limited data are available regarding the efficacy and safety of EUS-BD in patients with SAA. We conducted a multicenter prospective registration study to evaluate the efficacy and safety of EUS-BD in this population.Methods: This study involved 10 referral centers in Japan. Patients with SAA who were scheduled to receive EUS-BD for unresectable MBO between May 2016 and September 2018 were prospectively registered. The primary endpoint was technical success and the secondary outcomes were clinical success, procedure time, procedure-related adverse events (AEs), stent patency, and overall survival.Results: In total, 40 patients were prospectively enrolled. The surgical reconstruction methods were gastrectomy with Roux-en-Y reconstruction (47.5%), gastrectomy with Billroth-II reconstruction (15%), pancreaticoduodenectomy (27.5%), and hepaticojejunostomy with Roux-en-Y reconstruction (10%). EUS-BD was performed for primary biliary drainage in 31 patients and for rescue biliary drainage in nine patients. Transmural stenting alone (60%), antegrade stenting alone (5%), and a combination of the two techniques (35%) were selected for patients treated with EUS-BD. Technical and clinical success rates were 100% (95% confidence interval, 91.2–100.0%) and 95% (95% confidence interval, 83.1–99.4%), respectively. Mean procedure time was 36.5 min. Early AEs were noted in six patients (15%): three self-limited bile leak, one bile peritonitis, and two pneumoperitonea. Late AEs occurred in six patients (15%): one jejunal ulcer and five stent occlusions. Stent patency rate after 3 months of survival was 95.7% (22/23). Median overall survival was 96 days.Conclusion: EUS-BD for MBO in patients with SAA appears to be effective and safe not only as a rescue drainage technique after failed endoscopic retrograde cholangiography but also as a primary drainage technique.Clinical Trial Registration: UMIN000022101