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Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction.
Clin Gastroenterol Hepatol. 2016 07; 14(7):1011-1019.e3.CG

Abstract

BACKGROUND & AIMS

Although percutaneous transhepatic biliary drainage (PTBD) is the standard method for draining a malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatographies (ERCPs), use of endoscopic ultrasound-guided transmural biliary drainage (EUS-BD) is increasing. We performed a multicenter, open-label, randomized trial to compare EUS-BD vs PTBD for malignant distal biliary obstruction after a failed ERCP.

METHODS

Patients with unresectable malignant distal biliary obstructions and failed primary ERCP, caused by inaccessible papilla, were assigned to groups that underwent EUS-BD with an all-in-one device for direct deployment of a partially covered metal stent (without further fistula tract dilation, n = 34) or PTBD (n = 32). The procedures were performed at 4 tertiary academic referral centers in South Korea from October 2014 through March 2015; patients were followed up through June 2015. The primary end point was technical success, which was calculated using a noninferiority model. Secondary end points were functional success, procedure-related adverse events, rate of unscheduled re-intervention, and quality of life (QOL).

RESULTS

The rates of primary technical success were 94.1% (32 of 34) in the EUS-BD group and 96.9% (31 of 32) in the PTBD group (1-sided 97.5% confidence interval lower limit, -12.7%; P = .008 for a noninferiority margin of 15%). The rates of functional success were 87.5% (28 of 32) in the EUS-BD group and 87.1% (27 of 31) in the PTBD group (P = 1.00). The proportions of procedure-related adverse events were 8.8% in the EUS-BD group vs 31.2% in the PTBD group (P = .022); the mean frequency of unscheduled re-intervention was 0.34 in the EUS-BD group vs 0.93 in the PTBD group (P = .02). The QOL was similar between groups.

CONCLUSIONS

EUS-BD and PTBD had similar levels of efficacy in patients with unresectable malignant distal biliary obstruction and inaccessible papilla based on rates of technical and functional success and QOL. However, EUS-BD produced fewer procedure-related adverse events and unscheduled re-interventions. Clinical trial registration no: cris.nih.go.kr/KCT0001370.

Authors+Show Affiliations

Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, South Korea.Department of Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, South Korea.Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. Electronic address: dhpark@amc.seoul.kr.Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Pusan, South Korea.Department of Internal Medicine, Inje University Ilsan Paik Hospital, Inje University School of Medicine, Ilsan, South Korea.Division of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, South Korea.Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26748220

Citation

Lee, Tae Hoon, et al. "Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction." Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, vol. 14, no. 7, 2016, pp. 1011-1019.e3.
Lee TH, Choi JH, Park do H, et al. Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction. Clin Gastroenterol Hepatol. 2016;14(7):1011-1019.e3.
Lee, T. H., Choi, J. H., Park, d. o. . H., Song, T. J., Kim, D. U., Paik, W. H., Hwangbo, Y., Lee, S. S., Seo, D. W., Lee, S. K., & Kim, M. H. (2016). Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction. Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, 14(7), 1011-e3. https://doi.org/10.1016/j.cgh.2015.12.032
Lee TH, et al. Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction. Clin Gastroenterol Hepatol. 2016;14(7):1011-1019.e3. PubMed PMID: 26748220.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction. AU - Lee,Tae Hoon, AU - Choi,Jun-Ho, AU - Park,Do Hyun, AU - Song,Tae Jun, AU - Kim,Dong Uk, AU - Paik,Woo Hyun, AU - Hwangbo,Young, AU - Lee,Sang Soo, AU - Seo,Dong Wan, AU - Lee,Sung Koo, AU - Kim,Myung-Hwan, Y1 - 2015/12/31/ PY - 2015/09/16/received PY - 2015/12/05/revised PY - 2015/12/08/accepted PY - 2016/1/10/entrez PY - 2016/1/10/pubmed PY - 2017/8/22/medline KW - Biliary Tract Obstruction KW - ERCP KW - Endoscopic Ultrasound KW - Percutaneous Transhepatic Biliary Drainage SP - 1011 EP - 1019.e3 JF - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association JO - Clin. Gastroenterol. Hepatol. VL - 14 IS - 7 N2 - BACKGROUND & AIMS: Although percutaneous transhepatic biliary drainage (PTBD) is the standard method for draining a malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatographies (ERCPs), use of endoscopic ultrasound-guided transmural biliary drainage (EUS-BD) is increasing. We performed a multicenter, open-label, randomized trial to compare EUS-BD vs PTBD for malignant distal biliary obstruction after a failed ERCP. METHODS: Patients with unresectable malignant distal biliary obstructions and failed primary ERCP, caused by inaccessible papilla, were assigned to groups that underwent EUS-BD with an all-in-one device for direct deployment of a partially covered metal stent (without further fistula tract dilation, n = 34) or PTBD (n = 32). The procedures were performed at 4 tertiary academic referral centers in South Korea from October 2014 through March 2015; patients were followed up through June 2015. The primary end point was technical success, which was calculated using a noninferiority model. Secondary end points were functional success, procedure-related adverse events, rate of unscheduled re-intervention, and quality of life (QOL). RESULTS: The rates of primary technical success were 94.1% (32 of 34) in the EUS-BD group and 96.9% (31 of 32) in the PTBD group (1-sided 97.5% confidence interval lower limit, -12.7%; P = .008 for a noninferiority margin of 15%). The rates of functional success were 87.5% (28 of 32) in the EUS-BD group and 87.1% (27 of 31) in the PTBD group (P = 1.00). The proportions of procedure-related adverse events were 8.8% in the EUS-BD group vs 31.2% in the PTBD group (P = .022); the mean frequency of unscheduled re-intervention was 0.34 in the EUS-BD group vs 0.93 in the PTBD group (P = .02). The QOL was similar between groups. CONCLUSIONS: EUS-BD and PTBD had similar levels of efficacy in patients with unresectable malignant distal biliary obstruction and inaccessible papilla based on rates of technical and functional success and QOL. However, EUS-BD produced fewer procedure-related adverse events and unscheduled re-interventions. Clinical trial registration no: cris.nih.go.kr/KCT0001370. SN - 1542-7714 UR - https://www.unboundmedicine.com/medline/citation/26748220/Similar_Efficacies_of_Endoscopic_Ultrasound_guided_Transmural_and_Percutaneous_Drainage_for_Malignant_Distal_Biliary_Obstruction_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1542-3565(15)01716-4 DB - PRIME DP - Unbound Medicine ER -