Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.
A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.
Orlando Health
Orlando, Florida, United States
Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
Proportion of patients unable to tolerate a solid diet at time of hospital discharge (defined as gastric outlet obstruction scoring system score \<2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
Time frame: 6 months
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Proportion of patients with Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Time frame: 6 months
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Proportion of patients with Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Time frame: 6 months
Rate of technical success
Technical success is defined as the successful creation of a gastrojejunal anastomosis by the originally assigned method.
Time frame: 24 hours
Procedure duration
Procedure duration for EUS-guided and surgical gastrojejunostomy procedures
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Time frame: 24 hours
Time to diet advancement
Time to liquid diet (GOOSS score 1), soft solid diet (GOOSS score 2) and regular solid diet (GOOSS score 3).
Time frame: 1 month
Time to recurrence of obstructive symptoms
Recurrence of obstructive symptoms, defined as the recurrence of obstructive symptoms (GOOSS score ≤ 1) after achieving GOOSS ≥ 2 for at least 7 days at any time during follow-up.
Time frame: 6 months
Rate of persistence of symptoms
Persistent of obstructive symptoms, defined as continuing symptoms up to 2 weeks after index procedure.
Time frame: 6 months
Rate of reintervention
Reintervention, defined as need for repeat treatment for persistent or recurrent obstructive symptoms. Reintervention can be any endoscopic or surgical therapy.
Time frame: 6 months
Total number of readmissions
Total no. of readmissions due to disease-related symptoms or procedure-related events.
Time frame: 6 months
Rate of adverse events due to procedures performed
Procedure-related adverse events
Time frame: 6 months
Rate of adverse events due to underlying disease
Disease-related adverse events
Time frame: 6 months
Total length of hospital stay
Duration of hospitalization, defined as the length of hospital stay from the date of the procedure to the date of discharge.
Time frame: 6 months
Length of survival
Duration of survival post-procedure.
Time frame: 6 months
Time to initiation of chemotherapy post-procedure
Time to initiation of chemotherapy post-procedure
Time frame: 6 months
Quality of life measurement
Quality of life post-procedure as determined by the EORTC-QLQ-C30 quality of life questionnaire.
Time frame: 6 months
Treatment costs
All relevant costs pertaining to treatment of gastric outlet obstruction will be taken into consideration from index intervention to hospital discharge: procedure costs, inpatient hospital stay from date of procedure to discharge, medications, materials, anesthesia, pharmacy and imaging studies.
Time frame: 6 months