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Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

Primary Purpose

Gastric Outlet Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EUS-guided gastrojejunostomy
Surgical gastrojejunostomy
Sponsored by
Orlando Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Outlet Obstruction focused on measuring Gastric outlet obstruction, Endoscopic ultrasound, Surgery, Malignancy, Gastrojejunostomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Presence of gastric outlet obstruction on any imaging or endoscopy from known or suspected malignancy
  3. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)

Exclusion Criteria:

  1. Age < 18 years
  2. Intrauterine pregnancy
  3. Use of anticoagulants that cannot be discontinued for the procedure
  4. Unable to obtain consent for the procedure from either the patient or LAR

Sites / Locations

  • Orlando HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EUS-guided gastrojejunostomy

Surgical gastrojejunostomy

Arm Description

EUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent

A surgical gastrojejunostomy will be created via laparoscopic or open technique, as clinically appropriate.

Outcomes

Primary Outcome Measures

Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring endoscopic or surgical intervention or supplemental nutrition or procedure-related adverse events.
Proportion of patients unable to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring endoscopic or surgical intervention or supplemental nutrition or procedure-related adverse events.

Secondary Outcome Measures

Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Proportion of patients with Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Proportion of patients with Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Rate of technical success
Technical success is defined as the successful creation of a gastrojejunal anastomosis by the originally assigned method.
Procedure duration
Procedure duration for EUS-guided and surgical gastrojejunostomy procedures
Time to diet advancement
Time to liquid diet (GOOSS score 1), soft solid diet (GOOSS score 2) and regular solid diet (GOOSS score 3).
Time to recurrence of obstructive symptoms
Recurrence of obstructive symptoms, defined as the recurrence of obstructive symptoms (GOOSS score ≤ 1) after achieving GOOSS ≥ 2 for at least 7 days at any time during follow-up.
Rate of persistence of symptoms
Persistent of obstructive symptoms, defined as continuing symptoms up to 2 weeks after index procedure.
Rate of reintervention
Reintervention, defined as need for repeat treatment for persistent or recurrent obstructive symptoms. Reintervention can be any endoscopic or surgical therapy.
Total number of readmissions
Total no. of readmissions due to disease-related symptoms or procedure-related events.
Rate of adverse events due to procedures performed
Procedure-related adverse events
Rate of adverse events due to underlying disease
Disease-related adverse events
Total length of hospital stay
Duration of hospitalization, defined as the length of hospital stay from the date of the procedure to the date of discharge.
Length of survival
Duration of survival post-procedure.
Quality of life measurement
Quality of life post-procedure as determined by the EORTC-QLQ-C30 quality of life questionnaire.
Overall treatment costs from index procedure until 6 months post-index procedure.
All relevant costs pertaining to treatment of gastric outlet obstruction will be taken into consideration: procedure costs, inpatient hospital stay from date of procedure to discharge, readmissions, medications, materials, anesthesia, pharmacy and imaging studies.

Full Information

First Posted
September 16, 2022
Last Updated
October 9, 2023
Sponsor
Orlando Health, Inc.
Collaborators
West Virginia University, Rush University
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1. Study Identification

Unique Protocol Identification Number
NCT05548114
Brief Title
Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
Official Title
Randomized Trial Comparing Endoscopic Ultrasound-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orlando Health, Inc.
Collaborators
West Virginia University, Rush University

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
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Outlet Obstruction
Keywords
Gastric outlet obstruction, Endoscopic ultrasound, Surgery, Malignancy, Gastrojejunostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS-guided gastrojejunostomy
Arm Type
Active Comparator
Arm Description
EUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent
Arm Title
Surgical gastrojejunostomy
Arm Type
Active Comparator
Arm Description
A surgical gastrojejunostomy will be created via laparoscopic or open technique, as clinically appropriate.
Intervention Type
Procedure
Intervention Name(s)
EUS-guided gastrojejunostomy
Intervention Description
AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.
Intervention Type
Procedure
Intervention Name(s)
Surgical gastrojejunostomy
Intervention Description
A surgical gastrojejunostomy will be created via laparoscopic (preferred) or open technique, as clinically appropriate.
Primary Outcome Measure Information:
Title
Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring endoscopic or surgical intervention or supplemental nutrition or procedure-related adverse events.
Description
Proportion of patients unable to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring endoscopic or surgical intervention or supplemental nutrition or procedure-related adverse events.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Description
Proportion of patients with Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Time Frame
6 months
Title
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Description
Proportion of patients with Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Time Frame
6 months
Title
Rate of technical success
Description
Technical success is defined as the successful creation of a gastrojejunal anastomosis by the originally assigned method.
Time Frame
24 hours
Title
Procedure duration
Description
Procedure duration for EUS-guided and surgical gastrojejunostomy procedures
Time Frame
24 hours
Title
Time to diet advancement
Description
Time to liquid diet (GOOSS score 1), soft solid diet (GOOSS score 2) and regular solid diet (GOOSS score 3).
Time Frame
1 month
Title
Time to recurrence of obstructive symptoms
Description
Recurrence of obstructive symptoms, defined as the recurrence of obstructive symptoms (GOOSS score ≤ 1) after achieving GOOSS ≥ 2 for at least 7 days at any time during follow-up.
Time Frame
6 months
Title
Rate of persistence of symptoms
Description
Persistent of obstructive symptoms, defined as continuing symptoms up to 2 weeks after index procedure.
Time Frame
6 months
Title
Rate of reintervention
Description
Reintervention, defined as need for repeat treatment for persistent or recurrent obstructive symptoms. Reintervention can be any endoscopic or surgical therapy.
Time Frame
6 months
Title
Total number of readmissions
Description
Total no. of readmissions due to disease-related symptoms or procedure-related events.
Time Frame
6 months
Title
Rate of adverse events due to procedures performed
Description
Procedure-related adverse events
Time Frame
6 months
Title
Rate of adverse events due to underlying disease
Description
Disease-related adverse events
Time Frame
6 months
Title
Total length of hospital stay
Description
Duration of hospitalization, defined as the length of hospital stay from the date of the procedure to the date of discharge.
Time Frame
6 months
Title
Length of survival
Description
Duration of survival post-procedure.
Time Frame
6 months
Title
Quality of life measurement
Description
Quality of life post-procedure as determined by the EORTC-QLQ-C30 quality of life questionnaire.
Time Frame
6 months
Title
Overall treatment costs from index procedure until 6 months post-index procedure.
Description
All relevant costs pertaining to treatment of gastric outlet obstruction will be taken into consideration: procedure costs, inpatient hospital stay from date of procedure to discharge, readmissions, medications, materials, anesthesia, pharmacy and imaging studies.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Presence of gastric outlet obstruction on any imaging or endoscopy from known or suspected malignancy Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only) Exclusion Criteria: Age < 18 years Intrauterine pregnancy Use of anticoagulants that cannot be discontinued for the procedure Unable to obtain consent for the procedure from either the patient or LAR
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Young Bang, MD, MPH
Phone
321-841-2431
Email
jiyoung.bang@orlandohealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara J Broome
Phone
321-841-7031
Email
barbara.broome@orlandohealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Young Bang, MD MPH
Organizational Affiliation
Orlando Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Young Bang, MD, MPH
Phone
321-841-2431
Email
jiyoung.bang@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Barbara J Broome
Phone
321-841-7031
Email
barbara.broome@orlandohealth.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

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