Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2010-01-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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EUS-BD or ERCP with duodenal SEMS
Patients who underwent endoscopic placement of a duodenal self-expandable metal stent (SEMS) for nonresectable malignant GOO and endoscopic biliary drainage for nonresectable distal MBO.
Biliary drainage
EUS-BD or ERCP
Interventions
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Biliary drainage
EUS-BD or ERCP
Eligibility Criteria
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Inclusion Criteria
* Patients who underwent endoscopic biliary drainage for nonresectable MBO.
* MBO was located ≥ 2 cm from the bifurcation.
* Patients who could be followed up more than three months after completion of both biliary drainage and duodenal SEMS placement.
* Age ≥20 years.
* Irrespective of sex and a primary disease.
Exclusion Criteria
* Patients who underwent percutaneous and surgical biliary drainage prior to the placement of duodenal SEMS.
* Patients with altered gastrointestinal anatomy (Billroth-II reconstruction, Roux-en-Y reconstruction, etc.).
* Patients who would not give a consent to the report of their own data.
* Patients considered ineligible for inclusion in the study by an investigator for other reasons.
20 Years
ALL
No
Sponsors
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Tokyo University
OTHER
Responsible Party
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Hiroyuki Isayama, MD, PhD
Associate Professor
Principal Investigators
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Hiroyuki Isayama, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Graduate School of Medicine, The University of Tokyo
Locations
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Eastern Hepatobiliary Hospital, Second Military Medical University
Shanghai, , China
The Prince of Wales Hospital
Shatin, , Hong Kong
Asian Institute of Gastroenterology
Hyderabad, , India
Fukushima Medical University
Fukushima, , Japan
Gifu University
Gifu, , Japan
Onomichi General Hospital
Hiroshima, , Japan
Teine-Keijinkai Hospital
Hokkaido, , Japan
Sapporo Medical University
Hokkaido, , Japan
Hokkaido University School of Medicine
Hokkaido, , Japan
Kinki University
Osaka, , Japan
Saitama Medical University International Medical Center
Saitama, , Japan
Graduate School of Medicine, The University of Tokyo
Tokyo, , Japan
Japanese Red Cross Medical Center
Tokyo, , Japan
Toho University Ohashi Medical Center
Tokyo, , Japan
Kanto Central Hospital
Tokyo, , Japan
Tokyo Medical University
Tokyo, , Japan
Tokyo Metropolitan Police Hospital
Tokyo, , Japan
Prince Court Medical Center
Kuala Lumpur, , Malaysia
Singapore General Hospital
Outram Road, , Singapore
Changi General Hospital
Simei New Town, , Singapore
Asan Medical Center
Seoul, , South Korea
Soon Chun Hyang University School of Medicine
Seoul, , South Korea
National Taiwan University Hospital
Taipei, , Taiwan
Chulalongkorn University
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Countries
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References
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Maire F, Hammel P, Ponsot P, Aubert A, O'Toole D, Hentic O, Levy P, Ruszniewski P. Long-term outcome of biliary and duodenal stents in palliative treatment of patients with unresectable adenocarcinoma of the head of pancreas. Am J Gastroenterol. 2006 Apr;101(4):735-42. doi: 10.1111/j.1572-0241.2006.00559.x.
Kaw M, Singh S, Gagneja H. Clinical outcome of simultaneous self-expandable metal stents for palliation of malignant biliary and duodenal obstruction. Surg Endosc. 2003 Mar;17(3):457-61. doi: 10.1007/s00464-002-8541-3. Epub 2002 Oct 31.
Mutignani M, Tringali A, Shah SG, Perri V, Familiari P, Iacopini F, Spada C, Costamagna G. Combined endoscopic stent insertion in malignant biliary and duodenal obstruction. Endoscopy. 2007 May;39(5):440-7. doi: 10.1055/s-2007-966327.
Moon JH, Choi HJ. Endoscopic double-metallic stenting for malignant biliary and duodenal obstructions. J Hepatobiliary Pancreat Sci. 2011 Sep;18(5):658-63. doi: 10.1007/s00534-011-0409-2.
Hamada T, Nakai Y, Isayama H, Sasaki T, Kogure H, Kawakubo K, Sasahira N, Yamamoto N, Togawa O, Mizuno S, Ito Y, Hirano K, Toda N, Tada M, Koike K. Duodenal metal stent placement is a risk factor for biliary metal stent dysfunction: an analysis using a time-dependent covariate. Surg Endosc. 2013 Apr;27(4):1243-8. doi: 10.1007/s00464-012-2585-9. Epub 2012 Oct 17.
Kahaleh M, Hernandez AJ, Tokar J, Adams RB, Shami VM, Yeaton P. Interventional EUS-guided cholangiography: evaluation of a technique in evolution. Gastrointest Endosc. 2006 Jul;64(1):52-9. doi: 10.1016/j.gie.2006.01.063.
Horaguchi J, Fujita N, Noda Y, Kobayashi G, Ito K, Obana T, Takasawa O, Koshita S, Kanno Y. Endosonography-guided biliary drainage in cases with difficult transpapillary endoscopic biliary drainage. Dig Endosc. 2009 Oct;21(4):239-44. doi: 10.1111/j.1443-1661.2009.00899.x.
Itoi T, Isayama H, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Tsuji S, Ishii K, Ikeuchi N, Tanaka R, Umeda J, Moriyasu F, Kawakami H. Stent selection and tips on placement technique of EUS-guided biliary drainage: transduodenal and transgastric stenting. J Hepatobiliary Pancreat Sci. 2011 Sep;18(5):664-72. doi: 10.1007/s00534-011-0410-9.
Kawakubo K, Isayama H, Nakai Y, Sasahira N, Kogure H, Sasaki T, Hirano K, Tada M, Koike K. Simultaneous Duodenal Metal Stent Placement and EUS-Guided Choledochoduodenostomy for Unresectable Pancreatic Cancer. Gut Liver. 2012 Jul;6(3):399-402. doi: 10.5009/gnl.2012.6.3.399. Epub 2012 Jul 12.
Hamada T, Nakai Y, Lau JY, Moon JH, Hayashi T, Yasuda I, Hu B, Seo DW, Kawakami H, Kuwatani M, Katanuma A, Kitano M, Ryozawa S, Hanada K, Iwashita T, Ito Y, Yagioka H, Togawa O, Maetani I, Isayama H. International study of endoscopic management of distal malignant biliary obstruction combined with duodenal obstruction. Scand J Gastroenterol. 2018 Jan;53(1):46-55. doi: 10.1080/00365521.2017.1382567. Epub 2017 Oct 6.
Related Links
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Tokyo Conference of Asian Pancreato-biliary Interventional Endoscopist
Other Identifiers
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10639
Identifier Type: -
Identifier Source: org_study_id
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