Endoscopic vs Surgical Gastrojejunostomy for Gastric Outlet Obstruction

(EAT-GO Trial)

Recruiting at 2 trial locations

Overseen By Hye Jeong Jang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Pregnancy, Previous surgery, Ascites, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: Immediate procedure

32 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{2 3 4 6 7}

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

My doctor expects me to live more than 2 months or I had a failed duodenal stent procedure.

Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)

My cancer cannot be removed by surgery or has spread to other parts.

Exclusion Criteria

I am under 18 years old.

I have fluid buildup in my abdomen.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either endoscopic or surgical gastrojejunostomy to treat gastric outlet obstruction

Immediate procedure

1 visit (in-person)

Immediate Follow-up

Participants are monitored for adverse events and quality of life immediately following the procedure

1 week

Daily visits (in-person)

Extended Follow-up

Participants are monitored for safety, effectiveness, and quality of life at various intervals post-procedure

1 year

Visits at 30 days, 3 months, 6 months, and 1 year (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic gastrojejunostomy (EGJ)
• Surgical gastrojejunostomy (SGJ)

Trial Overview

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.

How Is the Trial Designed?

Group I: Endoscopic gastrojejunostomy (EGJ) Experimental Treatment 1 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 Control 1 Intervention

An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.

Endoscopic gastrojejunostomy (EGJ) is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Endoscopic gastrojejunostomy for:

• Gastric outlet obstruction due to malignancies
• Benign gastric outlet obstruction

Approved in United States as Endoscopic gastrojejunostomy for:

• Gastric outlet obstruction due to malignancies
• Benign gastric outlet obstruction

Approved in Japan as Endoscopic gastrojejunostomy for:

• Gastric outlet obstruction due to malignancies
• Benign gastric outlet obstruction

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

The nasojejunal tube-assisted endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) technique demonstrated a high technical success rate of 96.67% in treating gastric outlet obstruction (GOO) in 30 patients, with all patients achieving clinical success in tolerating a normal diet.

The procedure was found to be safe, with a low adverse event rate of 6.6%, and no recurrence of symptoms was observed during a median follow-up of 210 days, indicating long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasojejunal tube-assisted endoscopic ultrasound-guided gastrojejunostomy for the management of gastric outlet obstruction is safe and effective. Rai, P., Kumar, P., Goel, A., et al.[2023]

Endoscopic ultrasound-guided gastroenterostomy (EUS-G) shows similar clinical success rates to surgical gastrojejunostomy (SGJJ) but has better outcomes in terms of shorter hospital stays, reducing length of stay by an average of 5.8 days compared to SGJJ.

EUS-G has a comparable safety profile to SGJJ, with similar rates of serious adverse events, but significantly lower rates of reintervention due to obstruction compared to endoscopic stenting (ES), indicating it may be a more effective option for managing malignant gastric outlet obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative therapy for malignant gastric outlet obstruction: how does the endoscopic ultrasound-guided gastroenterostomy compare with surgery and endoscopic stenting? A systematic review and meta-analysis. Martins, RK., Brunaldi, VO., Fernandes, AL., et al.[2023]

Ultrasonography-guided gastrojejunostomy (EUS-GJ) is a promising minimally invasive treatment for gastric outlet obstruction (GOO), showing effectiveness in alleviating symptoms without complications in a 78-year-old patient with pancreatic cancer.

In this case, EUS-GJ successfully relieved the obstruction for 1.5 months post-procedure, indicating its potential as a safe alternative to traditional surgical methods for managing GOO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pancreatic head cancer with obstructive jaundice by endoscopy ultrasonography-guided gastrojejunostomy: A case report and literature review. Shen, Z., Tian, L., Wang, X.[2022]

In a study of 54 patients with gastric outlet obstruction, endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) demonstrated similar efficacy to laparoscopic gastrojejunostomy (Lap-GJ) in creating a gastrojejunostomy, with technical success rates of 88% for EUS-GJ and 100% for Lap-GJ.

EUS-GJ had significantly fewer adverse events (12%) compared to Lap-GJ (41%), indicating that EUS-GJ is a safer, minimally invasive alternative for patients not suitable for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided Gastrojejunostomy Versus Laparoscopic Gastrojejunostomy: An International Collaborative Study. Perez-Miranda, M., Tyberg, A., Poletto, D., et al.[2022]

EUS-guided gastroenterostomy (EUS-GE) allows patients with malignant gastric outlet obstruction to resume oral intake significantly faster (1.40 days) and with a shorter hospital stay (5.31 days) compared to surgical gastrojejunostomy (SGJ), which takes longer (4.06 days and 8.54 days, respectively).

EUS-GE has a lower rate of adverse events (13.4% vs 33.3% for SGJ) and enables patients to start or resume chemotherapy sooner (16.6 days vs 37.8 days), making it a safer and more efficient option for patients, even those with lower nutritional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of EUS-guided gastroenterostomy over surgical gastrojejunostomy in the palliation of malignant gastric outlet obstruction: a large multicenter experience. Canakis, A., Bomman, S., Lee, DU., et al.[2023]

Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) demonstrated a high technical success rate of 92% and a clinical success rate of 85% in a study of 26 patients, making it an effective option for managing gastric outlet obstruction.

The procedure showed a relatively low complication rate, with only 11.5% of patients experiencing adverse events, suggesting that EUS-GJ is a safe and minimally invasive alternative to traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience. Tyberg, A., Perez-Miranda, M., Sanchez-Ocaña, R., et al.[2022]

Endoscopic ultrasound guided gastrojejunostomy (EUS-GJ) is a highly effective procedure for managing gastric outlet obstruction (GOO), achieving technical and clinical success in 92% of the 25 patients studied, most of whom had malignant disease and were considered high surgical risks.

The procedure demonstrated a low adverse event rate of 8%, with only two patients experiencing complications related to stent maldeployment, indicating that EUS-GJ is a safe option when performed by experienced endoscopists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound guided gastrojejunostomy in the treatment of gastric outlet obstruction: multi-centre experience from the United Kingdom. On, W., Huggett, MT., Young, A., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6286920/

Endoscopic ultrasound guided gastrojejunostomy - PMC

In afferent loop syndrome initial data show high technical and clinical success rates and decreased need for reintervention. With malignant GOO, ...

2.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07522-7

Endoscopic ultrasonography-guided gastroenterostomy ...

The ENDURO-study assesses whether EUS-GE, as compared to SGJ, results in a faster resumption of solid oral intake and is non-inferior regarding reinterventions.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1590865825002932

Meta-Analysis What is the benefit of endoscopic ultrasound ...

Our findings show that EUS-GJ is effective and safe in those patients with bGOO in whom other endoscopic treatments fail, and surgery is not an option.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06128018

NCT06128018 | Comparing Endoscopic Ultrasound vs ...

The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.

5.

giejournal.org

giejournal.org/article/S0016-5107(20)32356-7/fulltext

Su1270 EFFICACY AND SAFETY OF ENDOSCOPIC ...

The majority had malignant gastric outlet obstruction (86%). Seven patients (35%) had previous enteric stenting without clinical success. We performed EUS-GJ ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9106441/

Efficacy and safety of endoscopic ultrasound-guided ...

Efficacy and safety of endoscopic ultrasound-guided gastrojejunostomy in patients with malignant gastric outlet obstruction and ascites. Tala ...

7.

wjgnet.com

wjgnet.com/1948-5190/full/v15/i11/634.htm

Endoscopic ultrasound guided gastroenterostomy

Endoscopic ultrasound guided gastroenterostomy: Technical details updates, clinical outcomes, and adverse events.