Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment
Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer
post prandial vomiting,
abdominal pain,
inability to tolerate PO,
Age< 18 years old
Pregnancy
Intestinal obstruction distal to the Ligament of Treitz
Evidence of other luminal strictures of the GI tract
Parallel
Surgical gastrojejunostomy (SGJ)
Procedure/SurgeryLaparoscopic gastrojejunostomy
Endoscopic gastrojejunostomy (EGJ)
Procedure/SurgeryEndoscopic ultrasound (EUS) guided gastrojejunostomy
Time to initiation of solid oral intake without symptoms of GOO
Days to initiation of solid oral intake will be measured from randomization to first day of intake of soft solid foods, as indicated by a GOOSS score of 2
Safety of procedure
All adverse events (AEs) occurring after treatment will be graded according to ASGE lexicon. A subject will be considered to have had an adverse event if they had one or more adverse events, and they will be considered to have had a serious adverse event (SAE) if they had one or more serious adverse events
Technical success of procedure
Technical success is defined as adequate deployment and positioning of the stent(s) for EGJ or technical possibility to create an anastomosis for SGJ.
Clinical success of procedure
Clinical success is defined as improvement to a GOOSS score of 2 or 3 (oral intake of soft solid foods or resumption of full diet) without additional intervention.
Time to discharge
Length of stay will be measured from randomization to discharge alive. All patients will be followed until discharge. Patients who die in hospital will be considered censored and time from randomization to death will be used.
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Northwell Health
Lead sponsor
Rutgers, The State University of New Jersey
Collaborator
