Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
ConditionMalignant Gastric Outlet Obstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdventHealth
About this trial
The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years of age.
Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.
GOOSS of 0 or 1
BOTH surgical and endoscopic GJ are technically and clinically feasible
Disqualifiers
< 18 years of age
ECOG >2
Expected survival (determined by the treating oncologist) is less than 2 months.
Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)
Trial design
Design model
Parallel
Treatments tested in this trial
Surgical gastrojejunostomy (S-GJ)
Procedure/SurgerySurgical gastro-jejunostomy
EUS-guided gastrojejunostomy (EUS-GJ)
Procedure/SurgeryEndoscopic Ultrasound guided gastro-jejunostomy
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: EUS-guided gastrojejunostomy (EUS-GJ)Other 1 intervention
Group B: Surgical gastrojejunostomy (S-GJ)Other 1 intervention
Trial outcomes
Primary outcomes
1
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 MonthsSecondary outcomes
1
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 MonthsSponsors and contacts
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Source ClinicalTrials.gov