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

34 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 EUS Gastrojejunostomy and Surgical Gastrojejunostomy for gastric outlet obstruction?

Research shows that EUS Gastrojejunostomy is a promising treatment for gastric outlet obstruction, offering similar clinical success to Surgical Gastrojejunostomy but with fewer complications. It also provides a more durable solution than other non-surgical options, with shorter recovery times and lower costs. ^{1 2 3 4 5}

Is EUS-GE safe for treating gastric outlet obstruction?

Research shows that endoscopic ultrasound-guided gastrojejunostomy (EUS-GE) is generally safe for treating gastric outlet obstruction, with fewer overall adverse events compared to surgical gastrojejunostomy. ^{1 6 7 8 9}

How does EUS Gastrojejunostomy differ from other treatments for gastric outlet obstruction?

EUS Gastrojejunostomy is a minimally invasive procedure that uses endoscopic ultrasound to create a new connection between the stomach and the small intestine, allowing food to bypass the obstruction. It offers a faster recovery and fewer complications compared to traditional surgery, making it a suitable option for patients who are not ideal candidates for surgery. ^{1 2 10 11 12}

What is the purpose of this trial?

Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach. EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach \[4\]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.

Research Team

Patrick Yachimski, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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 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]

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]

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

Endoscopic Ultrasound-Guided Gastrojejunostomy. [2018]

3. 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]

4. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided gastroenterostomy versus surgical gastrojejunostomy in treatment of malignant gastric outlet obstruction: Systematic review and meta-analysis. [2022]

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

Novel EUS-guided gastrojejunostomy technique using a new double-balloon enteric tube and lumen-apposing metal stent (with videos). [2022]

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

EUS-guided gastroenterostomy versus surgical gastroenterostomy for the management of gastric outlet obstruction: a systematic review and meta-analysis. [2022]

7. 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]

8. Germany pubmed.ncbi.nlm.nih.gov

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

9. 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]

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

Endoscopic Treatment of Gastric Outlet Obstruction. [2023]

11. United States 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. [2023]

12. United States 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. [2023]