B-GOOD: Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction.

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Recruiting

CT.gov ID

NCT05142839

Collaborator

(none)

500

Enrollment

Location

Arms

9.5

Anticipated Duration (Months)

52.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Biliary Obstruction	Procedure: EUS-CD Procedure: EUS-GEA	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 15, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EUS-CD EUS-guided choledochoduodenostomy	Procedure: EUS-CD EUS-guided choledochoduodenostomy
Experimental: EUS-GEA EUS-guided gastroenterostomy	Procedure: EUS-GEA EUS-guided gastroenterostomy

Arm

Intervention/Treatment

Experimental: EUS-CD

EUS-guided choledochoduodenostomy

Procedure: EUS-CD

EUS-guided choledochoduodenostomy

Experimental: EUS-GEA

EUS-guided gastroenterostomy

Procedure: EUS-GEA

EUS-guided gastroenterostomy

Outcome Measures

Primary Outcome Measures

Clinical success for EUS-CD [6 Months]
Decreased of total bilirubin > 50% or normalization of bilirubin within 2 weeks
Clinical success for EUS-GEA and enteral stenting [6 Months]
resolution of symptoms of GOO, with improvement in enteral diet assumption (creamy or solid) comparing to the baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Humanitas Research Hospital	Rozzano	Milano	Italy	20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Clinico Humanitas

ClinicalTrials.gov Identifier:

NCT05142839

Other Study ID Numbers:

First Posted:

Dec 3, 2021

Last Update Posted:

Feb 22, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pyloric Stenosis

Gastric Outlet Obstruction

Study Results

No Results Posted as of Feb 22, 2022