An interventional study of Surgical gastrojejunostomy (S-GJ) and EUS-guided gastrojejunostomy (EUS-GJ) in Malignant Gastric Outlet Obstruction, sponsored by AdventHealth. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by AdventHealth · Not applicable, Interventional, and Treatment
The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.
The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction. The main question this study aims to answer is:
1. To compare the rates of procedure related adverse events (AE's) between patients undergoing Endoscopy Ultrasound-guided gastro-jejunostomy (EUS-GJ) and Surgical gastro-jejunostomy (S-GJ).
Study participants will be randomized into one of the two standard procedures and followed for up to 12 months post procedure for collection of outcomes related data
38 studies on the registry are indexed under Gastric Outlet Obstruction; 14 are open to participants now.
This study's planned enrollment of 70 is close to the median of 69 across 28 interventional studies indexed under Gastric Outlet Obstruction.
Browse Gastric Outlet Obstruction studies →AdventHealth is the lead sponsor of 113 studies on the registry; 22 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients on this arm will undergo the endoscopic procedure.
Procedure: Surgical gastrojejunostomy (S-GJ)
Patients on this arm will undergo the surgical procedure.
Procedure: EUS-guided gastrojejunostomy (EUS-GJ)
Surgical gastro-jejunostomy
Endoscopic Ultrasound guided gastro-jejunostomy
Identify safety profile EUS-GJ
The severity of AEs will be determined using standard American Society of Gastrointestinal Endoscopy (ASGE) Lexicon and AGREE criteria (appendix) in the EUS-GJ group.
Time frame: 24 Months
Identify safety profile for S-GJ
The severity of AEs will be determined using Claviden-Dindo classification of surgical complications in the S-GJ group.
Time frame: 24 Months
Plan to share: No
Started Nov 2023 (actual). Primary completion is estimated for Sep 2026, 34 months after the start.
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