Clinical trial NCT05548114: Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
Official title: Randomized Trial Comparing Endoscopic Ultrasound-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastric Outlet Obstruction
Keywords: Gastric outlet obstruction
Endoscopic ultrasound
Surgery
Malignancy
Gastrojejunostomy
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
Collaborators: name: West Virginia University
name: Rush University
name: Asian Institute of Gastroenterology, India
name: Medanta, The Medicity, India
name: University of Hamburg-Eppendorf
First posted: 2022-09-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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).
timeFrame: 6 months
measure: 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).
timeFrame: 6 months
measure: Rate of technical success
timeFrame: 24 hours
measure: Procedure duration
timeFrame: 24 hours
measure: Time to diet advancement
timeFrame: 1 month
measure: Time to recurrence of obstructive symptoms
timeFrame: 6 months
measure: Rate of persistence of symptoms
timeFrame: 6 months
measure: Rate of reintervention
timeFrame: 6 months
measure: Total number of readmissions
timeFrame: 6 months
measure: Rate of adverse events due to procedures performed
timeFrame: 6 months
measure: Rate of adverse events due to underlying disease
timeFrame: 6 months
measure: Total length of hospital stay
timeFrame: 6 months
measure: Length of survival
timeFrame: 6 months
measure: Time to initiation of chemotherapy post-procedure
timeFrame: 6 months
measure: Quality of life measurement
timeFrame: 6 months
measure: Treatment costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health
name: Ji Young Bang, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: