Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction.
NCT ID: NCT05142839
Last Updated: 2022-02-22
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
NA
500 participants
INTERVENTIONAL
2021-12-15
2022-09-30
Brief Summary
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Above all, EUS-guided choledochoduodenostomy (EUS-CD) is to date considered a valuable option of treatment in case of distal malignant biliary obstruction in case of failure of endoscopic retrograde cholangiopancreatography (ERCP) due to the presence of a gastric or duodenal obstruction, unreachable papilla in case of altered anatomy, infiltrated papilla or failure of deep cannulation of the common bile duct. This modality of drainage demonstrated satisfying results, with high rate both of technical and clinical success with acceptable rate of adverse events.
When the distal malignant biliary obstruction is associated to signs and symptoms of gastric outflow obstruction (GOO) due to the presence of a gastric or duodenal stenosis, a concomitant or subsequent palliation of the stenosis may be required.
Recently, EUS-guided gastroenterostomy (EUS-GEA) has been introduced for the palliation of GOO, showing good results although technically challenging.
To date, endoscopic treatment in case of GOO, enteral stenting and EUS-GEA are possible alternatives. However, available data demonstrated that EUS-GEA seems to be superior to enteral stenting in terms of rate of reinterventions during long-term follow-up, especially when life expectancy is superior to 6 months.
However, data are lacking regarding which is the best strategy when GOO is associated to distal malignant biliary obstruction, especially when EUS-CD is performed. This is an hot topic, as it has been supposed that EUS-CD has higher rate of adverse events, especially food impaction, when a duodenal stenosis is present.
The aim of our study, therefore, is to perform a retrospective multicenter study collecting all consecutive patients affect by distal malignant biliary obstruction drained using EUS-CD, with associated GOO treated with concomitant or subsequent duodenal stenting or EUS-GEA, in order to evaluate clinical efficacy, long term outcomes and severity of adverse events.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EUS-CD
EUS-guided choledochoduodenostomy
EUS-CD
EUS-guided choledochoduodenostomy
EUS-GEA
EUS-guided gastroenterostomy
EUS-GEA
EUS-guided gastroenterostomy
Interventions
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EUS-CD
EUS-guided choledochoduodenostomy
EUS-GEA
EUS-guided gastroenterostomy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Enteral stenting or EUS-GEA performed before EUS-CD
* Provide an estimate of number of records you plan to review and time period that it will be covered.January 2016 to September 2021
* If the number of records you plan to exceeds 500, please provide the following:
N/A
\- Provide an estimate of how long it will take you to complete the study, including the time for data analysis.
3 month for data collection and 3 weeks for data analysis
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Locations
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Department of Gastroenterology, Humanitas Research Hospital
Rozzano, Milano, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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12
Identifier Type: -
Identifier Source: org_study_id
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