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

Phase 3

Recruiting

• Conditions: Malignant neoplasm of ill-definedsites within the digestive system,

• Registration Number: CTRI/2022/11/047173
• Lead Sponsor: Dr Jayanta Samanta

Brief Summary

Endoscopic ultrasound guided gastrojejunostomy (EUS-GJ) using lumen apposing metal stent  (LAMS) is a relatively newer modality for palliation of malignant GOO. It is minimally invasive, provides rapid relief of symptoms, with long term patency of the anastomosis created (leading to lower reinterventions), it has gained widespread recognition as a first line choice for GOO. Few multicentre studies exist comparing EUS-GJ with surgical GJ. EUS-GJ has been shown to have performed as well as a surgical GJ with lower adverse event rates and shorter recovery time. But there are no prospective randomised controlled studies for the same. Hence this study has been designed as an open-label randomized controlled trial (RCT) to compare EUS-GJ with laparoscopic GJ for  malignant GOO.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-14
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 46

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.	At 3 days and 3 months

Secondary Outcome Measures

Name	Time	Method
1.Technical success	2.Clinical success

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research, Chandigarh, India; 🇮🇳 Chandigarh, CHANDIGARH, India

Post Graduate Institute of Medical Education and Research, Chandigarh, India

🇮🇳Chandigarh, CHANDIGARH, India

Jayanta Samanta

Principal investigator

9855319529

dj_samanta@yahoo.co.in