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Procedure

EUS-guided gastrojejunostomy (EUS-GJ) for Gastric Outlet Obstruction (RESTORE Trial)

N/A
Recruiting
Led By Kambiz Kadkhodayan, MD
Research Sponsored by AdventHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

RESTORE Trial Summary

This trial aims to compare two different ways of treating a blockage in the stomach caused by cancer to see which one is more effective.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects may include pain, infection, bleeding, or injury at the procedure site. Endoscopic treatment might also cause pancreatitis or leakage where the intestine is joined. Surgical risks include complications from anesthesia and longer recovery times.

RESTORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identify safety profile EUS-GJ
Secondary outcome measures
Identify safety profile for S-GJ

RESTORE Trial Design

2Treatment groups
Experimental Treatment
Group I: Surgical gastrojejunostomy (S-GJ)Experimental Treatment1 Intervention
Patients on this arm will undergo the surgical procedure.
Group II: EUS-guided gastrojejunostomy (EUS-GJ)Experimental Treatment1 Intervention
Patients on this arm will undergo the endoscopic procedure.

Find a Location

Who is running the clinical trial?

AdventHealthLead Sponsor
107 Previous Clinical Trials
29,509 Total Patients Enrolled
Kambiz Kadkhodayan, MDPrincipal InvestigatorAdventHealth

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still eligible to enroll in this ongoing clinical trial?

"Indeed, as per details on clinicaltrials.gov, this investigation is actively pursuing candidates. Initially shared on the 1st of November 2023 and recently revised on the 7th of March 2024, it aims to enroll a total of 70 individuals at one designated site."

Answered by AI

What is the current number of individuals actively participating in this research endeavor?

"Indeed, the details on clinicaltrials.gov affirm that this research endeavor is presently in need of participants. The trial was initially disclosed on November 1st, 2023, and underwent its latest revision on March 7th, 2024. Seeking to enlist a total of 70 individuals, the study aims to recruit from a single designated site."

Answered by AI
Recent research and studies
EndoscopyJournal
Endoscopic Ultrasound-guided Gastroenterostomy Using Novel Tools Designed for Transluminal Therapy: A Porcine Study
Binmoeller, K., and J. Shah. 2012. “Endoscopic Ultrasound-guided Gastroenterostomy Using Novel Tools Designed for Transluminal Therapy: A Porcine Study”. Endoscopy. Georg Thieme Verlag KG. doi:10.1055/s-0032-1309382.
Gastrointestinal EndoscopyJournal
Eus-guided Gastroenterostomy: The First U.S. Clinical Experience (with Video)
Khashab, Mouen A., Vivek Kumbhari, Ian S. Grimm, Saowanee Ngamruengphong, Gerard Aguila, Mohamad El Zein, Anthony N. Kalloo, and Todd H. Baron. 2015. “Eus-guided Gastroenterostomy: The First U.S. Clinical Experience (with Video)”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2015.06.017.
clinicaltrials.govStudy
Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
2023. "Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06128018.
~47 spots leftby Dec 2025
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