Endoscopic vs Surgical Gastrojejunostomy for Gastric Outlet Obstruction
(EAT-GO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments for gastric outlet obstruction (GOO), a condition often caused by cancers that block the stomach's exit. The goal is to determine which treatment—endoscopic gastrojejunostomy (EGJ) or surgical gastrojejunostomy (SGJ)—better alleviates symptoms like nausea and vomiting and helps patients eat normally. EGJ involves placing a stent to bypass the blockage using a scope, while SGJ involves surgery to connect the stomach to the small intestine. The trial seeks participants with specific cancers who experience symptoms like frequent vomiting or severe stomach pain and cannot eat solid food. As an unphased trial, it offers patients the chance to contribute to valuable research that could enhance future treatment options for GOO.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these procedures are safe for treating gastric outlet obstruction?
Research has shown that endoscopic gastrojejunostomy (EGJ) is generally safe for patients with a blockage in the stomach area. In studies, most patients tolerated the procedure well and did not experience serious side effects, though some reported mild issues like temporary pain or discomfort afterward.
Surgical gastrojejunostomy (SGJ) is a more traditional surgery that connects the stomach to the small intestine. It is well-known and commonly used. Like any surgery, it carries risks such as infection or bleeding, but medical teams usually manage these effectively.
Both treatments aim to help patients eat more easily and improve their quality of life. They have been used in other situations with good safety records, indicating a low risk of serious side effects.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for gastric outlet obstruction because they offer less invasive options compared to traditional surgeries. The endoscopic gastrojejunostomy (EGJ) is a standout because it uses an endoscopic ultrasound to guide the placement of a stent, creating a new pathway between the stomach and small intestine without the need for large incisions. This approach potentially reduces recovery time and complications associated with open surgery. Meanwhile, the surgical gastrojejunostomy (SGJ) is a laparoscopic procedure, which is less invasive than traditional open surgery, aiming to achieve similar results with less trauma to the patient. Both methods highlight advancements in reducing patient recovery time and improving overall outcomes.
What evidence suggests that this trial's treatments could be effective for gastric outlet obstruction?
This trial compares endoscopic gastrojejunostomy (EGJ) with surgical gastrojejunostomy (SGJ) for treating gastric outlet obstruction (GOO). Research has shown that EGJ is highly successful, particularly when surgery isn't an option. Studies have found that EGJ enables patients to start eating solid foods sooner and reduces the need for additional procedures. It is also safe and effective for patients when other treatments have failed. Meanwhile, SGJ is a well-established method that creates a new pathway between the stomach and small intestine to bypass the blockage. Both treatments in this trial aim to relieve symptoms like nausea and vomiting, allowing patients to eat normally and receive proper nutrition.23467
Who Is on the Research Team?
Arvind Trindade, MD
Principal Investigator
Northwell Health
Petros Benias, MD
Principal Investigator
Northwell Health
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either endoscopic or surgical gastrojejunostomy to treat gastric outlet obstruction
Immediate Follow-up
Participants are monitored for adverse events and quality of life immediately following the procedure
Extended Follow-up
Participants are monitored for safety, effectiveness, and quality of life at various intervals post-procedure
What Are the Treatments Tested in This Trial?
Interventions
- Endoscopic gastrojejunostomy (EGJ)
- Surgical gastrojejunostomy (SGJ)
Endoscopic gastrojejunostomy (EGJ) is already approved in European Union, United States, Japan for the following indications:
- Gastric outlet obstruction due to malignancies
- Benign gastric outlet obstruction
- Gastric outlet obstruction due to malignancies
- Benign gastric outlet obstruction
- Gastric outlet obstruction due to malignancies
- Benign gastric outlet obstruction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor