Gastrojejunostomy Techniques for Gastric Outlet Obstruction

Overseen By Barbara J Broome

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Orlando Health, Inc.

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Unable to consent, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to treat gastric outlet obstruction, a condition where the stomach can't empty properly due to a blockage often linked to cancer. The study compares surgical gastrojejunostomy, which creates a new stomach connection through surgery, with EUS-guided gastrojejunostomy, a less invasive procedure using a special stent. The trial aims to determine which method works better for patients facing this serious issue. Ideal candidates for this trial have a cancer-related blockage in their stomach or duodenum and can only drink liquids. As an unphased trial, it offers patients the chance to contribute to valuable research that could improve future treatment options.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop taking anticoagulants (blood thinners) if they cannot be discontinued for the procedure. Other medications are not specified, so it's best to discuss with the trial team.

What prior data suggests that these gastrojejunostomy techniques are safe for treating gastric outlet obstruction?

Research has shown that EUS-guided gastrojejunostomy safely treats gastric outlet obstruction. In studies, most patients tolerated it well, with very few late side effects. Only 3.4% of patients experienced issues like stent blockage by food. This method is less invasive than surgery, often resulting in less pain and faster recovery.

For surgical gastrojejunostomy, research indicates it is a reliable option, though it carries a slightly higher risk of serious side effects. About 5.6% of patients experienced serious problems, yet it remains a trusted method for this condition. Both treatments have their advantages and disadvantages, but they are generally safe options for managing gastric outlet obstruction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these gastrojejunostomy techniques because they offer innovative approaches to treating gastric outlet obstruction. Unlike traditional surgical gastrojejunostomy, which typically involves more invasive methods, the EUS-guided gastrojejunostomy uses a lumen-apposing metal stent to create a bypass, potentially reducing recovery time and complications. The surgical gastrojejunostomy, performed with laparoscopic or robotic techniques, also seeks to minimize invasiveness compared to open surgery. These methods aim to improve patient outcomes by making the procedure less taxing on the body while maintaining effectiveness.

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

This trial will compare EUS-guided gastrojejunostomy with surgical gastrojejunostomy for treating malignant gastric outlet obstruction (GOO). Research has shown that both methods are effective. Participants in the EUS-guided gastrojejunostomy arm will undergo a procedure using a special tube placed with the assistance of an ultrasound camera inside the body. This method has proven safe and effective, particularly when other treatments fail, and studies indicate it helps patients resume eating solid foods quickly with fewer complications than surgery. Meanwhile, participants in the surgical gastrojejunostomy arm will undergo a more traditional method, often performed with small incisions and a camera, which has successfully helped patients eat again and live longer. Both treatments have demonstrated good results, but EUS-guided procedures might facilitate faster recovery. ^{3 5 6 7 8}

Who Is on the Research Team?

Ji Young Bang, MD, MPH

Principal Investigator

Orlando Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with gastric outlet obstruction due to cancer, who can only consume liquids. It's not for those under 18, pregnant women, or patients on anticoagulants that can't be stopped.

Inclusion Criteria

You have severe difficulty eating and can only consume liquids.

I have a blockage in my stomach due to cancer.

Exclusion Criteria

I am on blood thinners that cannot be stopped for a procedure.

I am under 18 years old.

Intrauterine pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either EUS-guided gastrojejunostomy or surgical gastrojejunostomy

1 day

1 visit (in-person)

Follow-up

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

6 months

Multiple visits (in-person and virtual)

Long-term follow-up

Participants are monitored for long-term outcomes such as survival and recurrence of symptoms

6 months

What Are the Treatments Tested in This Trial?

Interventions

• EUS-guided gastrojejunostomy
• Surgical gastrojejunostomy

Trial Overview The study compares two procedures in patients with malignant gastric outlet obstruction: EUS-guided gastrojejunostomy (a less invasive endoscopic procedure) and traditional surgical gastrojejunostomy.

How Is the Trial Designed?

Group I: Surgical gastrojejunostomy Active Control 1 Intervention

A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.

Group II: EUS-guided gastrojejunostomy Active Control 1 Intervention

EUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent

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

Approved in European Union as EUS-GJ for:

• Malignant gastric outlet obstruction
• Benign gastric outlet obstruction
• Afferent loop syndrome

Approved in United States as EUS-GJ for:

• Malignant gastric outlet obstruction
• Benign gastric outlet obstruction

Approved in Japan as EUS-GJ for:

• Malignant gastric outlet obstruction

Who Is Running the Clinical Trial?

Orlando Health, Inc.

Lead Sponsor

Trials

32

Recruited

15,100+

The Medicity Hospital, Medanta

Collaborator

Trials

1

Recruited

70+

Asian Institute of Gastroenterology, India

Collaborator

Trials

99

Recruited

63,500+

Medanta, The Medicity, India

Collaborator

Trials

15

Recruited

9,800+

University of Hamburg-Eppendorf

Collaborator

Trials

38

Recruited

354,000+

Asian Institute of Gastroenterology Hospitals

Collaborator

Trials

1

Recruited

70+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Published Research Related to This Trial

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]

Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) demonstrated similar technical and clinical success rates compared to open gastrojejunostomy (OGJ) in treating gastric outlet obstruction, with no significant differences in symptom recurrence or reintervention rates among 66 patients studied.

EUS-GE allowed for faster resumption of oral intake and chemotherapy, shorter hospital stays, and significantly lower overall costs compared to OGJ, suggesting it may be a more efficient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided gastroenterostomy versus open surgical gastrojejunostomy: clinical outcomes and cost effectiveness analysis. Kouanda, A., Binmoeller, K., Hamerski, C., 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) 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]

EUS-guided gastrojejunostomy is a promising new procedure for treating gastric outlet obstruction in patients with advanced gastrointestinal cancers, offering potentially better durability and shorter recovery times compared to traditional enteral stenting and surgical options.

Using cautery-tipped lumen-apposing metal stents during the procedure increases technical success rates and reduces procedure times, highlighting the importance of technique in optimizing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Ultrasound-Guided Gastrojejunostomy. Amin, S., Sethi, A.[2018]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8316851/

Endoscopic ultrasound guided gastrojejunostomy for ... Durability and long-term outcomes of direct EUS-guided gastroenterostomy using lumen-apposing metal stents for gastric outlet obstruction.

2. 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.

3. journals.lww.com journals.lww.com/ctg/fulltext/2025/01000/long_term_outcomes_of_eus_guided.3.aspx

Long-Term Outcomes of EUS-Guided Gastroenterostomy Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is effective and safe in benign and malignant indications. However, there is a paucity of literature ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05605327

EUS-guided Versus Laparoscopic Gastrojejunostomy for ... This technique utilizes endoscopic ultrasound to connect the stomach to the jejunum at a site distal to the tumour obstruction. This techniques is minimally ...

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11811553/

Endoscopic ultrasound-guided gastroenterostomy: a review EUS-GE can be considered in patients with symptomatic GOO and evidence of outlet obstruction on cross-sectional imaging. Cross-sectional imaging ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6811354/

Efficacy and safety of EUS-guided gastroenterostomy for ... EUS-GE appears to provide an effective and safe minimally invasive alternative for treatment of benign and malignant gastric outlet obstruction.

8. gut.bmj.com gut.bmj.com/content/early/2025/09/24/gutjnl-2025-336339

Endoscopic or surgical gastroenterostomy for ... - Gut We therefore performed a multicentre randomised trial to investigate whether EUS-GE is superior to SGJ as the first-line treatment in patients with malignant ...