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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Biliary Obstruction
• Intervention / Treatment: Procedure: EUS-CD; Procedure: EUS-GEA

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Anderloni, MD; Phone Number: 0039-02-82247308; Email: andrea.anderloni@humanitas.it
• Study Contact Backup: Name: Alessandro Fugazza, MD; Phone Number: 0039-02-82247021; Email: alessandro.fugazza@humanitas.it

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Department of Gastroenterology, Humanitas Research Hospital
      • Contact: Alessandro Repici, MD; Phone Number: 0039-02-82247493; Email: alessandro.repici@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success for EUS-CD	Decreased of total bilirubin > 50% or normalization of bilirubin within 2 weeks	6 Months
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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pyloric Stenosis; Gastric Outlet Obstruction
• Other Study ID Numbers: 12 (Israel lung Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No