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Endoscopic vs Surgical Gastrojejunostomy for Gastric Outlet Obstruction (EAT-GO Trial)
N/A
Recruiting
Led By Petros Benias, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Life expectancy greater than 2 months or failed duodenal stenting
Unresectable or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
EAT-GO Trial Summary
This trial is testing a new technique to treat patients with gastric outlet obstruction (GOO) caused by cancer. The new technique is less invasive and may improve quality of life for these patients.
Who is the study for?
Adults over 18 with unresectable or metastatic periampullary malignancies or distal gastric cancer causing severe gastric outlet obstruction. They must be able to undergo general anesthesia, have a life expectancy of more than 2 months, and cannot eat solids (GOOSS Score of 0 or 1). Not eligible if they have abdominal ascites, other GI tract strictures, previous related surgeries, are pregnant, under 18, or can't complete quality of life surveys.Check my eligibility
What is being tested?
This study is testing two ways to treat blockages at the stomach exit: one group will receive an endoscopic gastrojejunostomy (EGJ), which is less invasive and done through the mouth; another group will get a surgical gastrojejunostomy (SGJ), which involves surgery on the belly. Patients are randomly assigned to either method.See study design
What are the potential side effects?
Possible side effects for both procedures include pain at the intervention site, infection risk from surgery or scope insertion, bleeding complications, potential injury to surrounding organs during procedure and post-operative digestive issues.
EAT-GO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My doctor expects me to live more than 2 months or I had a failed duodenal stent procedure.
Select...
My cancer cannot be removed by surgery or has spread to other parts.
Select...
I experience severe stomach issues like vomiting after eating and pain.
Select...
I can undergo surgery and tolerate being put to sleep with anesthesia.
Select...
I am older than 18 years.
Select...
My cancer originates near the bile duct, pancreas, or small intestine and may extend to the lower part of the stomach or small intestine.
EAT-GO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to initiation of solid oral intake without symptoms of GOO
Secondary outcome measures
Change in BMI
Change in Gastric Outlet Obstruction Symptom Score (GOOSS)
Change in Gut Function Score (GFS)
+7 moreEAT-GO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Endoscopic gastrojejunostomy (EGJ)Experimental Treatment1 Intervention
A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.
Group II: Surgical gastrojejunostomy (SGJ)Active Control1 Intervention
An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
457 Previous Clinical Trials
470,227 Total Patients Enrolled
Petros Benias, MDPrincipal InvestigatorNorthwell Health
1 Previous Clinical Trials
4 Total Patients Enrolled
Arvind Trindade, MDPrincipal InvestigatorNorthwell Health
2 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have fluid buildup in my abdomen.My doctor expects me to live more than 2 months or I had a failed duodenal stent procedure.My cancer cannot be removed by surgery or has spread to other parts.I have had surgery on my stomach or near the bile duct.I am older than 18 years.I have a blockage in my intestines below the upper part.I can undergo surgery and tolerate being put to sleep with anesthesia.I experience severe stomach issues like vomiting after eating and pain.My cancer originates near the bile duct, pancreas, or small intestine and may extend to the lower part of the stomach or small intestine.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical gastrojejunostomy (SGJ)
- Group 2: Endoscopic gastrojejunostomy (EGJ)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment of participants for this trial still in progress?
"Per the details on clinicaltrials.gov, this medical trial is not presently recruiting patients - as was last amended on September 27th 2022. However, there are 7 other studies requiring patient participation at present."
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