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

• Conditions: Malignant gastric outlet obstruction

• Registration Number: NL-OMON25505
• Lead Sponsor: MC Utrecht

Brief Summary

one

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

In order to be eligible for this study, a subject must meet all of the following 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 pyloric region 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 the ligament of Treitz), with small intestinal dilation/ileus. Note: patients with diffuse dilatation of the intestines should not be excluded;
-Cancer extending into the distal region or corpus of the stomach or around the ligament of Treitz. These types may pose a risk of negatively affecting gastrointestinal motility next to causing gastric outlet obstruction.
-Duodenal tube feeding is not tolerated, 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 (including large-volume ascites);
-WHO performance score of 4 (in bed 100% of time);
-Uncorrectable coagulopathy, defined by INR > 1.5 or platelets < 50 x 109/L;

Study & Design

• Study Type: Interventional
• Study Design: Not specified