Study to compare the safety and efficacy of surgical bypass versus endoscopic bypass for patients having gastric outflow block due to malignancy

Phase 3

Conditions: Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system

Registration Number: CTRI/2022/11/047173

Lead Sponsor: Dr Jayanta Samanta

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

1.Lack of informed consent

2.Pregnancy

3.Coagulation disorder (INR >1.5 or platelet count <50000/ul)

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events between EUS-GJ versus surgical GJ for management of malignant GOO.Timepoint: At 3 days and 3 months

Secondary Outcome Measures

Name	Time	Method
1.Technical success <br/ ><br>2.Clinical success <br/ ><br>3.Time taken for the procedure <br/ ><br>4.GOOS (gastric outlet obstruction score) <br/ ><br>5.Time to initiate of oral diet <br/ ><br>6.Time to full oral diet (GOOS 3) starting from the day of the procedure <br/ ><br>7.Quality of life assessment scores [EORTC QLQ-C30, SF-36 module] at baseline, 1 and 3 months <br/ ><br>8.Patency of gastro-jejunal anastomosis at 1 and 3 months <br/ ><br>9.Duration of gastro-jejunal patency <br/ ><br>10.Reintervention rates for recurrent GOO at 1, and 3 months <br/ ><br>11.Dysfunction rates at 1, and 3 months <br/ ><br>12.Overall survival rates <br/ ><br>13.Rate of recurrent GOO visualised endoscopically/radiologically at 1, and 3 months <br/ ><br>14.Time to recurrent GOO <br/ ><br>15.Mortality (due to any cause) <br/ ><br>Timepoint: 3 days, 1 mon, 3 months <br/ ><br>