Endoscopic vs Surgical Procedures for Gastric Outlet Obstruction

Overseen By Amy Motley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pregnancy, Cirrhosis, Obesity, 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 compares two procedures for treating gastric outlet obstruction caused by cancer. One group will undergo an endoscopic ultrasound (EUS) gastrojejunostomy, a less invasive procedure using a camera for guidance. The other group will receive a traditional surgical gastrojejunostomy. The trial aims to determine which method is more effective and results in a shorter hospital stay. Participants must have a confirmed cancer diagnosis causing blockage in the stomach area that surgery cannot cure. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both EUS gastrojejunostomy and surgical gastrojejunostomy are generally safe treatments for gastric outlet obstruction, a condition where the stomach's opening to the small intestine is blocked. Studies indicate that EUS gastrojejunostomy is less invasive and has a high success rate of about 89.2%. However, side effects such as fever and stomach pain have occurred in 16.2% of cases.

Surgical gastrojejunostomy is also considered safe and effective, with a slightly higher success rate of 94.2%. This method consistently delivers good results, making it a reliable choice for many patients.

Both procedures treat this condition, each with its own potential risks and benefits. Consulting a healthcare professional is crucial to determine the most suitable treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they compare two different approaches to addressing gastric outlet obstruction. One method, EUS Gastrojejunostomy, is a minimally invasive procedure that uses endoscopic ultrasound to create a new pathway for food to bypass the obstructed area. This technique might offer a quicker recovery and less surgical trauma compared to traditional surgical gastrojejunostomy, which involves open or laparoscopic surgery to achieve the same result. Exploring these options could lead to more personalized and effective care choices for patients.

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

This trial will compare EUS gastrojejunostomy with surgical gastrojejunostomy for treating gastric outlet obstruction (GOO). Studies have shown that EUS gastrojejunostomy, which uses a flexible tube to create a new pathway between the stomach and intestine, is effective for people with GOO. It boasts high success rates, with about 93.7% of procedures being technically successful and about 92.9% being clinically successful. Patients often begin eating sooner and experience shorter hospital stays compared to other treatments. Research indicates that surgical gastrojejunostomy can improve overall survival and follow-up treatments. Both treatments are promising, but EUS gastrojejunostomy might offer quicker recovery and shorter hospital stays. ^{6 7 8 9 10}

Who Is on the Research Team?

Patrick Yachimski, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with gastric outlet obstruction, a condition where the stomach's exit to the small intestine is blocked. Participants should be suitable candidates for either endoscopic or surgical procedures to create a new connection between the stomach and small intestine.

Inclusion Criteria

Able to provide informed consent

Biopsy-proven cancer

My cancer cannot be cured by surgery alone.

Exclusion Criteria

I am under 18 years old.

Pregnancy

International normalized ratio > 1.6

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either an Endoscopic Ultrasound (EUS) Gastrojejunostomy or Surgical Gastrojejunostomy procedure

1 day

1 visit (in-person)

Post-operative Hospital Stay

Participants are monitored in the hospital for recovery and restoration of oral intake

14 days

Follow-up

Participants are monitored for safety and effectiveness after discharge

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EUS Gastrojejunostomy
• Surgical Gastrojejunostomy

Trial Overview

The study compares two treatments: EUS gastroenterostomy (a non-surgical procedure using an endoscope) and surgical gastrojejunostomy (an operation). It aims to determine which method provides better outcomes for patients with malignant gastric outlet obstruction.

How Is the Trial Designed?

Group I: EUS Gastrojejunostomy Active Control 2 Interventions

Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure

Group II: Surgical Gastrojejunostomy Active Control 2 Interventions

Patient will undergo Surgical Gastrojejunostomy procedure.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

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Conclusion In this randomised trial, EUS-GE was superior to SGJ with regards to oral intake, need for reinterventions or supplemental nutrition, length of ...

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Endoscopic ultrasound-guided gastroenterostomy, with ...

Meta-analysis of a total of 35 cases showed high technical and clinical success rates (100%, 35/35). The adverse event (AE) rate was 11.4% (4/35) ...

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Systematic review of long-term effectiveness of endoscopic ...

Results: The cohort of 238 patients had a technical success rate of 93.7% and a clinical success rate of 92.9%. A total of 25 patients (10.5%) experienced ...

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pmc.ncbi.nlm.nih.gov

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

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Results A total of 55 patients (mean age of 67.0 ± 11.3 years, 40.0 % female) who underwent EUS-GJ, of whom 24 had ascites (small in 22, large ...