Health Condition 1: K315- Obstruction of duodenum
Conditions
Interventions
Intervention1: EUS-guided gastrojejunostomy: AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.
Duration of procedure: 20-30 minutes.
Control Intervention1
Sponsors
Ji Young Bang
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Presence of gastric outlet obstruction on any imaging or endoscopy from known or suspected malignancy 3. Gastric outlet obstruction Scoring System (GOOSS) of = 1 (defined as maximum oral intake of liquids only)
Exclusion criteria
Exclusion criteria: Age less than 18 years Intrauterine pregnancy Use of anticoagulants that cannot be discontinued for the procedure Unable to obtain consent for the procedure from either the patient or LAR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients unable to tolerate a solid diet (defined as gastric outlet obstruction scoring system) and overall rate of adverse eventTimepoint: 1. Pre index procedure 2. Post index procedure 3. Day of Discharge 4. 1 month post index procedure 5. 3 month post index procedure 6. 6 month post index procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 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).Timepoint: At 1-month post-procedure;Gastric Outlet Obstruction Scoring System (GOOSS) score of = 2 at 3-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).Timepoint: At 3-month post-procedure;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).Timepoint: At 6-month post-procedure;Length of survivalTimepoint: post-procedure.;Overall treatment costs from index procedure until 6 months post-index procedure.Timepoint: At 6 months post procedure;Procedure durationTimepoint: 24 hours;Quality of life measurementTimepoint: At baseline, discharge, 1 months and 6 months post procedure.;Rate of adverse events due to procedures performedTimepoint: From index procedure to upto 6 months;Rate of adverse events due to underlying diseaseTimepoint: From index procedure to upto 6 months;Rate of persistence of symptomsTimepoint: Up to 2 weeks after index procedure.;Rate of reinterventionTimepoint: During 6 months after Index procedure;Rate of technical successTimepoint: 24 hours;Time to diet advancementTimepoint: During 1 month;Time to recurrence of obstructive symptomsTimepoint: After achieving GOOSS = 2 for at least 7 days at any time during follow-up.;Total length of hospital stayTimepoint: From the date of the procedure to the date of discharge.;Total number of readmissionsTimepoint: During 6 months after Index procedure | — |
Countries
Australia, Germany, India, United States of America
Contacts
Public ContactDr Bimal Kumar Sahu
Medanta The Medicity
Outcome results
None listed