Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system
Conditions
Interventions
Intervention1: EUS Guided Gastrojejunostomy: EUS guided gastrojejunostomy will be done by the standard water-immersion technique. Fluid would be infused through the nasojejunal tube placed endoscopica
Sponsors
Dr Jayanta Samanta
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients >= 18 years of age with malignant symptomatic gastric outlet obstruction (GOO) requiring intervention with an unresectable malignant lesion (biopsy proven) or borderline/ locally advanced planned for neo-adjuvant therapy prior to surgery. 2. GOO confirmed endoscopically or radiologically. 3. GOOS (gastric outlet obstruction score) 0 (no oral intake) or 1 (only liquids). 4. The patient who gives informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1. Lack of informed consent 2. Pregnancy 3. Coagulation disorder (INR >1.5 or platelet count 4. Multiple level bowel obstruction confirmed radiologically (contrast study or computed tomography scans) 5. Prior endoscopic or surgical treatment for GOO. 6. Severe comorbidities precluding endoscopic treatment (cardiorespiratory instability, severe pulmonary disease, bleeding disorder) 7. Previous gastric, periampullary or duodenal surgery 8. Complete GOO evidenced by inability to either pass a wire/nasojejunal tube across the stricture and/or inability to opacify small bowel distal to the malignant stricture 9. Malignant conditions involving the stomach such as Linitis plastica, malignancy of the proximal stomach etc. 10. Life expectancy of less than 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events between EUS-GJ versus surgical GJ for management of malignant GOO.Timepoint: At 3 days and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Technical success 2. Clinical success 3. Time taken for the procedure 4. GOOS (gastric outlet obstruction score) 5. Time to initiate of oral diet 6. Time to full oral diet (GOOS 3) starting from the day of the procedure 7. Quality of life assessment scores [EORTC QLQ-C30, SF-36 module] at baseline, 1 and 3 months 8. Patency of gastro-jejunal anastomosis at 1 and 3 months 9. Duration of gastro-jejunal patency 10. Reintervention rates for recurrent GOO at 1, and 3 months 11. Dysfunction rates at 1, and 3 months 12. Overall survival rates 13. Rate of recurrent GOO visualised endoscopically/radiologically at 1, and 3 months 14. Time to recurrent GOO 15. Mortality (due to any cause) Timepoint: 3 days, 1 mon, 3 months | — |
Countries
India
Contacts
Public ContactJayanta Samanta
Post Graduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed