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Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial.
Gastrointestinal Endoscopy 2010 March
BACKGROUND: Both gastrojejunostomy (GJJ) and stent placement are commonly used palliative treatments of obstructive symptoms caused by malignant gastric outlet obstruction (GOO).
OBJECTIVE: Compare GJJ and stent placement.
DESIGN: Multicenter, randomized trial.
SETTING: Twenty-one centers in The Netherlands.
PATIENTS: Patients with GOO.
INTERVENTIONS: GJJ and stent placement.
MAIN OUTCOME MEASUREMENTS: Outcomes were medical effects, quality of life, and costs. Analysis was by intent to treat.
RESULTS: Eighteen patients were randomized to GJJ and 21 to stent placement. Food intake improved more rapidly after stent placement than after GJJ (GOO Scoring System score > or = 2: median 5 vs 8 days, respectively; P < .01) but long-term relief was better after GJJ, with more patients living more days with a GOO Scoring System score of 2 or more than after stent placement (72 vs 50 days, respectively; P = .05). More major complications (stent: 6 in 4 patients vs GJJ: 0; P = .02), recurrent obstructive symptoms (stent: 8 in 5 patients vs GJJ: 1 in 1 patient; P = .02), and reinterventions (stent: 10 in 7 patients vs GJJ: 2 in 2 patients; P < .01) were observed after stent placement compared with GJJ. When stent obstruction was not regarded as a major complication, no differences in complications were found (P = .4). There were also no differences in median survival (stent: 56 days vs GJJ: 78 days) and quality of life. Mean total costs of GJJ were higher compared with stent placement ($16,535 vs $11,720, respectively; P = .049 [comparing medians]). Because of the small study population, only initial hospital costs would have been statistically significant if the Bonferroni correction for multiple testing had been applied.
LIMITATIONS: Relatively small patient population.
CONCLUSIONS: Despite slow initial symptom improvement, GJJ was associated with better long-term results and is therefore the treatment of choice in patients with a life expectancy of 2 months or longer. Because stent placement was associated with better short-term outcomes, this treatment is preferable for patients expected to live less than 2 months. (
CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN 06702358.).
OBJECTIVE: Compare GJJ and stent placement.
DESIGN: Multicenter, randomized trial.
SETTING: Twenty-one centers in The Netherlands.
PATIENTS: Patients with GOO.
INTERVENTIONS: GJJ and stent placement.
MAIN OUTCOME MEASUREMENTS: Outcomes were medical effects, quality of life, and costs. Analysis was by intent to treat.
RESULTS: Eighteen patients were randomized to GJJ and 21 to stent placement. Food intake improved more rapidly after stent placement than after GJJ (GOO Scoring System score > or = 2: median 5 vs 8 days, respectively; P < .01) but long-term relief was better after GJJ, with more patients living more days with a GOO Scoring System score of 2 or more than after stent placement (72 vs 50 days, respectively; P = .05). More major complications (stent: 6 in 4 patients vs GJJ: 0; P = .02), recurrent obstructive symptoms (stent: 8 in 5 patients vs GJJ: 1 in 1 patient; P = .02), and reinterventions (stent: 10 in 7 patients vs GJJ: 2 in 2 patients; P < .01) were observed after stent placement compared with GJJ. When stent obstruction was not regarded as a major complication, no differences in complications were found (P = .4). There were also no differences in median survival (stent: 56 days vs GJJ: 78 days) and quality of life. Mean total costs of GJJ were higher compared with stent placement ($16,535 vs $11,720, respectively; P = .049 [comparing medians]). Because of the small study population, only initial hospital costs would have been statistically significant if the Bonferroni correction for multiple testing had been applied.
LIMITATIONS: Relatively small patient population.
CONCLUSIONS: Despite slow initial symptom improvement, GJJ was associated with better long-term results and is therefore the treatment of choice in patients with a life expectancy of 2 months or longer. Because stent placement was associated with better short-term outcomes, this treatment is preferable for patients expected to live less than 2 months. (
CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN 06702358.).
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