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

Recruiting

Conditions: Malignant gastric outlet obstruction
Malignant GOO
10018008

Registration Number: NL-OMON54213

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 96

Inclusion Criteria

- Adult patients with symptomatic malignant gastric outlet obstruction,
presenting with nausea, vomiting and/or inability to eat
- Gastric Outlet Obstruction Scoring System Score of 0 (no oral intake) or 1
(liquids only)
- Obstruction due to irresectable or metastatic malignancy without curative
treatment options
- Radiologically or endoscopically confirmed gastric outlet obstruction
- Location of obstruction extending from the distal 1/3 of the stomach (antrum)
to the distal duodenum (third part)
- Both treatments (SGJ and EUS-GE) are technically and clinically feasible
- Written informed consent

Exclusion Criteria

- Radiological or clinical suspicion of other strictures or obstructions along
the gastrointestinal tract (distal of Treitz), with small intestine intestinal
dilation/ileus. Note: patients with diffuse dilatation of the intestines should
not be excluded;
- Cancer extending into the body of the stomach or around the ligament of
Treitz;
- Duodenal tube feeding is not tolerated by the patient, despite adequate
position of the tube;
- Altered anatomy after previous gastric, periampullary or duodenal surgery;
- Previous SGJ as palliative treatment for the same condition;
- Inability to undergo surgery or upper endoscopy due to severe comorbidities;
- WHO performance score of 4 (in bed 100% of time);
- Uncorrectable coagulopathy, defined by INR>1.5 or platelets < 50 x 10^9/L;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the ability to eat, measured with co-primary<br /><br>endpoints: 1) time to oral intake, and 2) persistent or recurrent gastric<br /><br>outlet obstruction (GOO) symptoms requiring endoscopic or surgical<br /><br>reintervention.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Technical success;<br /><br>- Clinical success;<br /><br>- Gastroenterostomy dysfunction;<br /><br>- Reintervention;<br /><br>- Time to reintervention due to recurrent symptoms;<br /><br>- Adverse events; .<br /><br>- Quality of life;<br /><br>- Time to start chemotherapy;<br /><br>- Length of hospital stay;<br /><br>- Readmission rate;<br /><br>- Weight is defined as patients* weight in kilograms;<br /><br>- Survival;<br /><br>- Costs. </p><br>