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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for gastric outlet obstruction caused by cancer. One method uses an endoscope, a tube with a camera, to create a new opening from the stomach to the intestines (EUS-guided gastrojejunostomy, or EUS-GJ). The other method involves traditional surgery to achieve the same outcome (surgical gastrojejunostomy, or S-GJ). Individuals with a blockage in the lower stomach or upper intestine due to a tumor, who can undergo either procedure, might be suitable for this trial. As an unphased trial, it offers patients the chance to explore innovative treatment options that may improve their quality of life.

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 prior data suggests that these procedures are safe for managing gastric outlet obstruction?

Research has shown that EUS-guided gastrojejunostomy (EUS-GJ) can safely and effectively treat gastric outlet obstruction. Several studies found EUS-GJ to be a less invasive procedure that benefits patients. However, some studies also reported a high rate of side effects, indicating a risk of complications despite many patients doing well.

For surgical gastrojejunostomy (S-GJ), studies show it is generally well-tolerated. The surgery and recovery times, along with complications, are similar to other common procedures. Patients often recover well and experience outcomes comparable to other options.

Both treatments offer benefits but also carry some risks. Patients should discuss with their healthcare provider to determine the best option for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the techniques being compared for treating gastric outlet obstruction because they offer different approaches to bypassing the stomach blockage. The EUS-guided gastrojejunostomy (EUS-GJ) is a minimally invasive procedure that uses endoscopy to create a new passageway between the stomach and the small intestine. This technique could offer quicker recovery times and fewer complications compared to the more traditional surgical gastrojejunostomy (S-GJ), which involves open surgery to achieve the same outcome. By directly comparing these two methods, researchers hope to determine which approach provides better overall outcomes for patients.

What evidence suggests that this trial's treatments could be effective for gastric outlet obstruction?

This trial will compare Endoscopic Ultrasound-Guided Gastrojejunostomy (EUS-GJ) with Surgical Gastrojejunostomy (S-GJ) for treating gastric outlet obstruction. Research has shown that EUS-GJ is a safe and effective treatment, particularly when other methods fail or surgery is not feasible. It enables patients to resume eating solid food sooner and typically requires fewer follow-up procedures.

In contrast, studies indicate that S-GJ effectively manages gastric outlet obstruction, with patients often experiencing fewer complications and a quicker return to a normal diet. Both treatments are similarly successful in preventing the recurrence of blockage. Participants in this trial will be assigned to either the EUS-GJ or S-GJ treatment arm to evaluate these outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Kambiz Kadkhodayan, MD

Principal Investigator

AdventHealth

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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 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]

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]

Citations

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