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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Surgical gastro-jejunostomy
Endoscopic Ultrasound guided gastro-jejunostomy
AdventHealth Orlando
Orlando, Florida, United States
RECRUITINGIdentify 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.