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

Trial Summary

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 data supports the idea that Endoscopic vs Surgical Gastrojejunostomy for Gastric Outlet Obstruction is an effective treatment?

The available research shows that Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is an effective treatment for gastric outlet obstruction. It is considered a safe and minimally invasive option that avoids the complications associated with surgery. Studies indicate that EUS-GJ provides long-term relief without the risk of tumor growth blocking the passage again, and it doesn't interfere with other treatments like chemotherapy. Additionally, EUS-GJ has been shown to be a viable alternative to surgical methods, offering similar benefits with fewer risks. ^{1 2 3 4 5}

What safety data exists for endoscopic and surgical gastrojejunostomy for gastric outlet obstruction?

Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is considered safe and effective for managing gastric outlet obstruction, with studies highlighting its long-term luminal patency and reduced surgical morbidity. It is a minimally invasive alternative to surgical gastrojejunostomy (SGJ), which is effective but associated with higher complication rates. EUS-GJ with lumen-apposing metal stents has shown promising safety and efficacy outcomes in multicenter studies, although direct comparisons with laparoscopic gastrojejunostomy (Lap-GJ) are limited. ^{1 2 3 4 6}

Is Endoscopic gastrojejunostomy (EGJ) a promising treatment for gastric outlet obstruction?

Yes, Endoscopic gastrojejunostomy (EGJ) is a promising treatment for gastric outlet obstruction. It is a minimally invasive option that avoids the complications of surgery and provides long-term relief without the risk of tumor growth blocking the passage again. It also allows patients to eat normally and can be a safer choice for those who might not be in the best health for surgery. ^{1 2 4 5 7}

What is the purpose of this trial?

Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment

Research Team

Arvind Trindade, MD

Principal Investigator

Northwell Health

Petros Benias, MD

Principal Investigator

Northwell Health

Eligibility Criteria

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.

Pregnancy

I have fluid buildup in my abdomen.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Nasojejunal tube-assisted endoscopic ultrasound-guided gastrojejunostomy for the management of gastric outlet obstruction is safe and effective. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound guided gastrojejunostomy in the treatment of gastric outlet obstruction: multi-centre experience from the United Kingdom. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of pancreatic head cancer with obstructive jaundice by endoscopy ultrasonography-guided gastrojejunostomy: A case report and literature review. [2022]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

EUS-guided Gastrojejunostomy Versus Laparoscopic Gastrojejunostomy: An International Collaborative Study. [2022]

7. United States 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. [2023]