Gastric Outlet Obstruction
Conditions
Keywords
Gastric outlet obstruction, Endoscopic ultrasound, Surgery, Malignancy, Gastrojejunostomy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEUS-guided gastrojejunostomy
AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.
PROCEDURESurgical gastrojejunostomy
A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.
Sponsors
West Virginia University
Rush University
Asian Institute of Gastroenterology, India
Medanta, The Medicity, India
University of Hamburg-Eppendorf
Orlando Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy 3. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only) 4. Amenable to treatment by both EUS-guided and surgical gastrojejunostomy
Exclusion criteria
1. Age \< 18 years 2. Intrauterine pregnancy 3. Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy 4. Unable to obtain consent for the procedure from either the patient or LAR 5. Altered anatomy due to prior gastroduodenal surgery 6. Presence of other adhesions or synchronous obstructive lesions in the small bowel 7. Prior treatment for gastric outlet obstruction 8. Presence of large volume malignant ascites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 6 months | 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). |
| Rate of technical success | 24 hours | Technical success is defined as the successful creation of a gastrojejunal anastomosis by the originally assigned method. |
| Procedure duration | 24 hours | Procedure duration for EUS-guided and surgical gastrojejunostomy procedures |
| Time to diet advancement | 1 month | Time to liquid diet (GOOSS score 1), soft solid diet (GOOSS score 2) and regular solid diet (GOOSS score 3). |
| Time to recurrence of obstructive symptoms | 6 months | 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. |
| Rate of persistence of symptoms | 6 months | Persistent of obstructive symptoms, defined as continuing symptoms up to 2 weeks after index procedure. |
| Rate of reintervention | 6 months | Reintervention, defined as need for repeat treatment for persistent or recurrent obstructive symptoms. Reintervention can be any endoscopic or surgical therapy. |
| 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). | 6 months | 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). |
| Rate of adverse events due to procedures performed | 6 months | Procedure-related adverse events |
| Rate of adverse events due to underlying disease | 6 months | Disease-related adverse events |
| Total length of hospital stay | 6 months | Duration of hospitalization, defined as the length of hospital stay from the date of the procedure to the date of discharge. |
| Length of survival | 6 months | Duration of survival post-procedure. |
| Time to initiation of chemotherapy post-procedure | 6 months | Time to initiation of chemotherapy post-procedure |
| Quality of life measurement | 6 months | Quality of life post-procedure as determined by the EORTC-QLQ-C30 quality of life questionnaire. |
| Treatment costs | 6 months | 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. |
| Total number of readmissions | 6 months | Total no. of readmissions due to disease-related symptoms or procedure-related events. |
Countries
United States
Outcome results
None listed