Endoscopic Stenting versus Operative Intervention in Malignant Gastric Outlet Obstruction(STENTOP), a multi-center randomized controlled trial.

Completed

• Conditions: 10018008; 10017991; 10017998; Malignant gastric outlet obstruction

• Registration Number: NL-OMON35111
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Malignancy of peri-duodenal area
Gastric Oulet Obstruction Scoring System (GOOSS) <= 1
Life expectancy >= 4 weeks
Informed consent
Age >= 18 years

Exclusion Criteria

Potentially curable disease
Pre-procedural evidence of additional strictures in the gastrointestinal tract beyond the level of the duodenum
Previous gastrojejunostomy
Previous treatment with self-expandable metal stent for same condition

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of days alive within the first 24 weeks after intervention with an<br /><br>oral intake of at least soft solids (GOOSS >= 2)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Gut Function Score (GFS), technical success, length of procedure-related<br /><br>hospital stay, complication rate (including pain intensity using a numerical<br /><br>rating scale, NRS), recurrent obstruction and reintervention rate, quality of<br /><br>life (QoL), costs and survival.</p><br>