Endoscopic ultrasonography-guided gastroenterostomy versus surgical
gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO-study)

Rationale: Malignant gastric outlet obstruction (GOO) is a common problem in patients with advanced primary or metastatic malignancies located at the distal stomach and (peri)pancreatic region. The two standard methods of treating GOO are placement of an enteral self-expendable metallic stent (SEMS) or a surgical gastrojejunostomy (SGJ). In patients with a reasonable prognosis, placement of an enteral SEMS is not feasible since it carries high rates of reobstruction or stent migration after a certain amount of time. Therefore, in these patients, surgical gastrojejunostomy is indicated to bypass this obstruction and palliate obstructive symptoms.
Despite high technical success rates and a durable effect, SGJ is an invasive treatment that is associated with significant short-term morbidity, such as delayed gastric emptying, resulting in an ongoing inability to eat and a prolonged hospital stay. Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) using a Lumen Apposing Metal Stent (LAMS) is the newest technique in the palliative treatment of malignant GOO. EUS-GE creates a bypass in a minimally invasive manner, with the potential of providing both fast and lasting relief of obstructive symptoms. Despite promising preliminary data, current literature is limited to small and retrospective series. A prospective and comparative study is warranted, to compare short and long term efficacy of EUS-GE with SGJ.

Objective: To evaluate the efficacy of EUS-GE compared with SGJ in patients with malignant GOO.

Study design: Randomized Controlled Trial

Study population: Adult patients with a malignant gastric outlet obstruction due to locally advanced or metastatic, inoperable and unresectable cancer, without curative options.

Intervention: One group will be treated with the standard treatment (SGJ) and the other group will be treated with the investigational treatment (EUS-GE with LAMS [off label use]).

Main study parameters/endpoints: The main study endpoint is the ability to eat, measured with co-primary endpoints: 1) time to oral intake, and 2) persistent or recurrent GOO symptoms requiring reintervention.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden and risks of EUS-GE are expected to be lower than those of the standard treatment (SGJ). Participation in this therapeutic study offers patients with malignant GOO the opportunity to undergo EUS-GE, an investigational and minimally invasive treatment, instead of surgery. No additional visits or physical examinations are required for this study, unless medically indicated. The burden of follow-up within this study is limited and mainly concerns time that is spent to fill in a diary, short quality-of-life questionnaires and receive four short follow-up phone calls. Though the short-term results of EUS-GE are promising and seem to be beneficial, the long-term patency of EUS-GE has yet to be established and compared with the current standard treatment (SGJ). This can only adequately be achieved by comparing the efficacy of EUS-GE versus SGJ in these patients, in a randomized and prospective study with solid follow-up.

It is hypothesized that patients with malignant gastric outlet obstruction after having undergone an endoscopic ultrasound-guided gastroenterostomy will faster resume oral intake and have a similar adverse event risk profile as compared to a surgical gastrojejunostomy.

Four moments of telephonic contact in six months of follow-up

EUS-guided gastroenterostomy versus surgical gastrojejunostomy