To investigate which treatment modality is preferable in patients with an irresectable malignant gastric outlet obstruction: endoscopic stent placement or a surgical gastrojejunostomy.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of days alive within the first 24 weeks after intervention with an
oral intake of at least soft solids (GOOSS >= 2)
Secondary outcome
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.
Background summary
Malignant gastric outlet obstruction is a late complication in patients with
primary gastric or periampullary malignancy or metastatic disease. Palliation
of obstructive symptoms is essential in these patients. Surgical
gastrojejunostomy as well as endoscopic stent placement can be performed. At
this moment there isn*t a definite scientific based rationale to favor one over
the other with respect to efficacy, complications, quality of life and costs.
Study objective
To investigate which treatment modality is preferable in patients with an
irresectable malignant gastric outlet obstruction: endoscopic stent placement
or a surgical gastrojejunostomy.
Study design
Prospective, multi-center randomized controlled study with a follow-up of 24
weeks.
Intervention
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.
Study burden and risks
Patients will be contacted by telephone at regular intervals for assessing
questionnaires. Also, during the first 3 weeks patients will be asked to fill
in a symptom-diary. In our opinion this will not put burden on patients
significantly.
The randomisation between endoscopic stent placement and surgical intervention
will not expose patients to additional risks. Initially, stent placement seems
to be a less invasive procedure. However, recent studies demonstrate that on
the long term stent placement may be complicated with a higher rate
reobstruction and reintervention. Thus, at this moment it is unclear which
treatment modality is preferable with respect to risks and complications.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31101.078.09 |