Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction. (B-GOOD)
Primary Purpose
Malignant Biliary Obstruction
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EUS-CD
EUS-GEA
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Biliary Obstruction
Eligibility Criteria
Inclusion Criteria:
- patients undergoing affected by distal malignant biliari obstruction and gastric outflow obstruction undergone EUS-CD and EUS-GEA or enteral stenting drainage between January 2016 to September 2021
Exclusion Criteria:
- Age under 18
- 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
Sites / Locations
- Department of Gastroenterology, Humanitas Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EUS-CD
EUS-GEA
Arm Description
EUS-guided choledochoduodenostomy
EUS-guided gastroenterostomy
Outcomes
Primary Outcome Measures
Clinical success for EUS-CD
Decreased of total bilirubin > 50% or normalization of bilirubin within 2 weeks
Clinical success for EUS-GEA and enteral stenting
resolution of symptoms of GOO, with improvement in enteral diet assumption (creamy or solid) comparing to the baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT05142839
First Posted
November 22, 2021
Last Updated
February 4, 2022
Sponsor
Istituto Clinico Humanitas
1. Study Identification
Unique Protocol Identification Number
NCT05142839
Brief Title
Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction.
Acronym
B-GOOD
Official Title
Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction. A Retrospective, Multicenter Study. (B-GOOD Study).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
EUS-guided drainages has been largely widespread during the last 10 years, even thanks to the advent of dedicated devices, such as lumen apposing metal stents (LAMSs).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Biliary Obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EUS-CD
Arm Type
Experimental
Arm Description
EUS-guided choledochoduodenostomy
Arm Title
EUS-GEA
Arm Type
Experimental
Arm Description
EUS-guided gastroenterostomy
Intervention Type
Procedure
Intervention Name(s)
EUS-CD
Intervention Description
EUS-guided choledochoduodenostomy
Intervention Type
Procedure
Intervention Name(s)
EUS-GEA
Intervention Description
EUS-guided gastroenterostomy
Primary Outcome Measure Information:
Title
Clinical success for EUS-CD
Description
Decreased of total bilirubin > 50% or normalization of bilirubin within 2 weeks
Time Frame
6 Months
Title
Clinical success for EUS-GEA and enteral stenting
Description
resolution of symptoms of GOO, with improvement in enteral diet assumption (creamy or solid) comparing to the baseline
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- patients undergoing affected by distal malignant biliari obstruction and gastric outflow obstruction undergone EUS-CD and EUS-GEA or enteral stenting drainage between January 2016 to September 2021
Exclusion Criteria:
Age under 18
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Anderloni, MD
Phone
0039-02-82247308
Email
andrea.anderloni@humanitas.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Fugazza, MD
Phone
0039-02-82247021
Email
alessandro.fugazza@humanitas.it
Facility Information:
Facility Name
Department of Gastroenterology, Humanitas Research Hospital
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Repici, MD
Phone
0039-02-82247493
Email
alessandro.repici@humanitas.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction.
We'll reach out to this number within 24 hrs