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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35111

Enrollment

Registered

2010-08-26

Start date

2011-02-23

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant gastric outlet obstruction

Interventions

In one treatment group a Self Expandable Metal Stent (SEMS) will be used. In the other treatment group an open or laparoscopic gastrojejunostomy will be performed.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Malignancy of peri-duodenal area Gastric Oulet Obstruction Scoring System (GOOSS) = 4 weeks Informed consent Age >= 18 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Percentage of days alive within the first 24 weeks after intervention with an oral intake of at least soft solids (GOOSS >= 2)	—

Secondary

Measure	Time frame
Gut Function Score (GFS), technical success, length of procedure-related hospital stay, complication rate (including pain intensity using a numerical rating scale, NRS), recurrent obstruction and reintervention rate, quality of life (QoL), costs and survival.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)