Biliary Drainage in Patients With Duodenal Metal Stent
This trial is active, not recruiting.
|Start date||January 2010|
|End date||June 2014|
|Trial size||200 participants|
|Trial identifier||NCT02376907, 10639|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Shanghai, China||Eastern Hepatobiliary Hospital, Second Military Medical University||no longer recruiting|
|Shatin, Hong Kong||The Prince of Wales Hospital||no longer recruiting|
|Hyderabad, India||Asian Institute of Gastroenterology||no longer recruiting|
|Fukushima, Japan||Fukushima Medical University||no longer recruiting|
|Gifu, Japan||Gifu University||no longer recruiting|
|Hiroshima, Japan||Onomichi General Hospital||no longer recruiting|
|Hokkaido, Japan||Hokkaido University School of Medicine||no longer recruiting|
|Hokkaido, Japan||Sapporo Medical University||no longer recruiting|
|Hokkaido, Japan||Teine-Keijinkai Hospital||no longer recruiting|
|Osaka, Japan||Kinki University||no longer recruiting|
|Saitama, Japan||Saitama Medical University International Medical Center||no longer recruiting|
|Tokyo, Japan||Graduate School of Medicine, The University of Tokyo||no longer recruiting|
|Tokyo, Japan||Japanese Red Cross Medical Center||no longer recruiting|
|Tokyo, Japan||Kanto Central Hospital||no longer recruiting|
|Tokyo, Japan||Toho University Ohashi Medical Center||no longer recruiting|
|Tokyo, Japan||Tokyo Medical University||no longer recruiting|
|Tokyo, Japan||Tokyo Metropolitan Police Hospital||no longer recruiting|
|Seoul, Korea, Republic of||Asan Medical Center||no longer recruiting|
|Seoul, Korea, Republic of||Soon Chun Hyang University School of Medicine||no longer recruiting|
|Kuala Lumpur, Malaysia||Prince Court Medical Center||no longer recruiting|
|Outram Road, Singapore||Singapore General Hospital||no longer recruiting|
|Simei, Singapore||Changi General Hospital||no longer recruiting|
|Taipei, Taiwan||National Taiwan University Hospital||no longer recruiting|
|Bangkok, Thailand||Chulalongkorn University||no longer recruiting|
|Bangkok, Thailand||Rajavithi Hospital||no longer recruiting|
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.
Time to recurrent biliary obstruction
time frame: Up to 1 year
Causes of recurrent biliary obstruction
time frame: Up to 1 year
Functional success rate of biliary drainage
time frame: 2 weeks
Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity)
time frame: 30 days
time frame: Up to 2 year
Male or female participants at least 20 years old.
- 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.
- 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.
|Official title||Multinational Study on Endoscopic Management of Distal Malignant Biliary Obstruction Combined With Gastric Outlet Obstruction|
|Principal investigator||Hiroyuki Isayama, MD, PhD|
|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.|
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