Endoscopic Stenting versus Operative Intervention in Malignant Gastric Outlet Obstruction.

Recruiting

• Conditions: Malignant gastric outlet obstructionDutch: maaguitgangstenose

• Registration Number: NL-OMON28881
• Lead Sponsor: Erasmus Medical Center Rotterdam, Department of Gastroenterology and Hepatology

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Malignant neoplasm of peri-duodenal area;

2. Gastric Oulet Obstruction Scoring System (GOOSS, see below) ≤ 1;

Exclusion Criteria

1. Potentially curable disease;

2. Pre-procedural evidence of additional strictures in the gastrointestinal tract beyond the level of the duodenum;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of days alive within the first 24 weeks after intervention with an oral intake of at least soft solids (GOOSS ≥ 2).

Secondary Outcome Measures

Name	Time	Method
1. Gut Function Score (GFS);<br /><br>2. Technical success;<br /><br>3. Length of procedure-related hospital stay;<br /><br>4. Complication rate (including pain intensity using a numerical rating scale, NRS);<br /><br>5. Recurrent obstruction and reintervention rate;<br /><br>6. Quality of life (QoL);<br /><br>7. Costs;<br /><br>8. Survival.