Endoscopic vs Surgical Gastrojejunostomy for Gastric Outlet Obstruction

(RESTORE Trial)

Overseen By Petronio Martins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth

Disqualifiers: Age < 18, ECOG > 2, Survival < 2 months, Peritoneal carcinomatosis, Large volume ascites, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information 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 effectiveness of the treatment Endoscopic Ultrasound-Guided Gastrojejunostomy (EUS-GJ) for gastric outlet obstruction?

Research shows that Endoscopic Ultrasound-Guided Gastrojejunostomy (EUS-GJ) is a safe and effective treatment for gastric outlet obstruction, providing long-term relief without the risk of tumor growth blocking the passage again. It is a minimally invasive alternative to surgery, with studies indicating successful outcomes and fewer complications compared to traditional surgical methods. ^{1 2 3 4 5}

Is endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) safe for humans?

Research suggests that endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is generally safe for treating gastric outlet obstruction, with studies indicating it is a minimally invasive option with fewer complications compared to traditional surgical methods. ^{1 2 3 4 5}

How is the treatment for gastric outlet obstruction different from other treatments?

Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is a minimally invasive treatment for gastric outlet obstruction that uses a special metal stent to create a new connection between the stomach and the small intestine, avoiding the need for traditional surgery and reducing the risk of complications like tumor growth into the stent. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Research Team

Kambiz Kadkhodayan, MD

Principal Investigator

AdventHealth

Eligibility Criteria

This trial is for adults over 18 with a blockage in the lower stomach or duodenum due to cancer, who have severe symptoms like vomiting and weight loss. They must be able to undergo both endoscopic and surgical procedures to bypass the blockage and agree to participate by signing an informed consent form.

Inclusion Criteria

I can understand and am willing to sign the consent form before any study procedures.

I have severe symptoms from my illness.

I have a blockage in my stomach or upper small intestine shown by imaging or scope tests.

Exclusion Criteria

I am under 18 years old.

I need help with my daily activities due to my health condition.

My cancer might be removable through surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to undergo either Endoscopic Ultrasound-guided gastrojejunostomy (EUS-GJ) or Surgical gastrojejunostomy (S-GJ)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

12 months

Regular visits as per study protocol

Long-term follow-up

Participants are monitored for long-term safety and outcomes

24 months

Treatment Details

Interventions

• EUS-guided gastrojejunostomy (EUS-GJ)
• Surgical gastrojejunostomy (S-GJ)

Trial Overview The study compares two ways of managing malignant gastric outlet obstruction: one using an endoscope (EUS-GJ) and the other through surgery (S-GJ). It aims to see which method is more effective for patients with this condition.

Participant Groups

Group I: Surgical gastrojejunostomy (S-GJ) Experimental Treatment 1 Intervention

Patients on this arm will undergo the surgical procedure.

Group II: EUS-guided gastrojejunostomy (EUS-GJ) Experimental Treatment 1 Intervention

Patients on this arm will undergo the endoscopic procedure.

EUS-guided gastrojejunostomy (EUS-GJ) is already approved in European Union, United States for the following indications:

Approved in European Union as EUS-GJ for:

• Malignant gastric outlet obstruction

Approved in United States as EUS-GJ for:

• Malignant gastric outlet obstruction

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

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]

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]

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]

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]

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]

References

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

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

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

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

3. 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]

4. 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]

5. 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]