Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction.

Malignant Biliary Obstruction Clinical Trial

— B-GOOD  

Official title:

Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction. A Retrospective, Multicenter Study. (B-GOOD Study).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142839
• Other study ID #: 12
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2022
• Source: Istituto Clinico Humanitas
• Contact: Andrea Anderloni, MD
• Phone: 0039-02-82247308
• Email: andrea.anderloni[@]humanitas.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Malignant Biliary Obstruction
• Pyloric Stenosis

Intervention

Procedure:
• EUS-CD
EUS-guided choledochoduodenostomy
• EUS-GEA
EUS-guided gastroenterostomy

Locations

Country	Name	City	State
Italy	Department of Gastroenterology, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success for EUS-CD	Decreased of total bilirubin > 50% or normalization of bilirubin within 2 weeks	6 Months
Primary	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	6 Months