Clinical trial NCT02376907: Biliary Drainage in Patients With Duodenal Metal Stent
Official title: Multinational Study on Endoscopic Management of Distal Malignant Biliary Obstruction Combined With Gastric Outlet Obstruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Jaundice
Keywords: distal malignant biliary obstruction
endoscopic retrograde cholangiopancreatography
endoscopic ultrasound
gastric outlet obstruction
stent
Lead sponsor: Tokyo University
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent the initial duodenal SEMS between Jan/1/2010 and Jun/30/2014 are included.

Brief summary: This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO.

Detailed description: This is a multinational multicenter retrospective cohort study to evaluate the outcomes of endoscopic biliary drainage in patients with a duodenal SEMS. Endoscopic ultrasound-guided biliary drainage (EUS-BD), including choledochoduodenostomy, hepaticogastrostomy, antegrade biliary stenting or a combination, and endoscopic retrograde cholangiopancreatography (ERCP) with stenting are to be compared. Specifically, the outcomes are to be evaluated according to the timing of distal MBO in relation to GOO and the location of GOO.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent endoscopic placement of a duodenal SEMS for nonresectable malignant GOO.
* 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 surgical bypass for GOO.
* 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.

Primary outcomes:
measure: Time to recurrent biliary obstruction
timeFrame: Up to 1 year
Secondary outcomes:
measure: Causes of recurrent biliary obstruction
timeFrame: Up to 1 year
measure: Functional success rate of biliary drainage
timeFrame: 2 weeks
measure: Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity)
timeFrame: 30 days
measure: Survival time
timeFrame: Up to 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Hospital, Second Military Medical University
city: Shatin
country: Hong Kong
facility: The Prince of Wales Hospital
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
city: Fukushima
country: Japan
facility: Fukushima Medical University
city: Gifu
country: Japan
facility: Gifu University
city: Hiroshima
country: Japan
facility: Onomichi General Hospital
city: Hokkaido
country: Japan
facility: Teine-Keijinkai Hospital
city: Hokkaido
country: Japan
facility: Sapporo Medical University
city: Hokkaido
country: Japan
facility: Hokkaido University School of Medicine
city: Osaka
country: Japan
facility: Kinki University
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Tokyo
country: Japan
facility: Graduate School of Medicine, The University of Tokyo
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
city: Tokyo
country: Japan
facility: Toho University Ohashi Medical Center
city: Tokyo
country: Japan
facility: Kanto Central Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Police Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University School of Medicine
city: Kuala Lumpur
country: Malaysia
facility: Prince Court Medical Center
city: Outram Road
country: Singapore
facility: Singapore General Hospital
city: Simei
country: Singapore
facility: Changi General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn University
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
affiliation: Graduate School of Medicine, The University of Tokyo
name: Hiroyuki Isayama, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.