Endoscopic Stenting versus Operative Intervention in Malignant Gastric Outlet Obstruction.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28881

Enrollment

100

Registered

2010-12-05

Start date

2010-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Malignant gastric outlet obstruction Dutch: maaguitgangstenose

Interventions

1. Duodenal self expandable metal stent (SEMS)

2. Gastrojejunostomy.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Malignant neoplasm of peri-duodenal area; 2. Gastric Oulet Obstruction Scoring System (GOOSS, see below) ≤ 1; 3. Life expectancy ≥ 4 weeks; 4. Informed consent; 5. Age ≥ 18 years; 6. Physical condition allowing to undergo upper gastrointestinal endoscopy or surgery, depending on judgement of local anaesthesiologist.

Exclusion criteria

Exclusion criteria: 1. Potentially curable disease; 2. Pre-procedural evidence of additional strictures in the gastrointestinal tract beyond the level of the duodenum; 3. Previous gastrojejunostomy; 4. 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
1. Gut Function Score (GFS); 2. Technical success; 3. Length of procedure-related hospital stay; 4. Complication rate (including pain intensity using a numerical rating scale, NRS); 5. Recurrent obstruction and reintervention rate; 6. Quality of life (QoL); 7. Costs; 8. Survival.	—

Contacts

Public ContactP. Didden

Postbus 2040

p.didden@erasmusmc.nl+31 (0)10 7040704

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)