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

74 Participants Needed

Trial Summary

What is the purpose of this trial?

Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.

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 data supports the effectiveness of the treatment EUS-guided gastrojejunostomy for gastric outlet obstruction?

Research shows that EUS-guided gastrojejunostomy (EUS-GJ) is a safe and effective treatment for gastric outlet obstruction, providing long-term relief without the risk of tumor growth and avoiding the complications of surgery. It is considered a minimally invasive alternative to traditional surgical methods, with studies indicating successful outcomes and fewer adverse events. ^{1 2 3 4 5}

Is gastrojejunostomy safe for treating gastric outlet obstruction?

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 6}

How is EUS-guided gastrojejunostomy different from other treatments for gastric outlet obstruction?

EUS-guided gastrojejunostomy is a minimally invasive treatment that uses endoscopic ultrasound to create a connection between the stomach and the small intestine, offering a durable solution with fewer complications and shorter recovery time compared to traditional surgery. It avoids the risk of tumor ingrowth associated with stents and is considered a novel alternative to surgical gastrojejunostomy. ^{1 2 3 6 7}

Research Team

Ji Young Bang, MD, MPH

Principal Investigator

Orlando Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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+

Findings from Research

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]

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]

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]

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]

References

1. 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]

2. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience. [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. United States pubmed.ncbi.nlm.nih.gov

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

5. 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]

6. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided gastroenterostomy versus open surgical gastrojejunostomy: clinical outcomes and cost effectiveness analysis. [2022]

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

Endoscopic Ultrasound-Guided Gastrojejunostomy. [2018]