Endoscopic ultrasonography-guided gastroenterostomy versus surgicalgastrojejunostomy for palliation of malignant gastric outlet obstruction

MC Utrecht0 sites96 target enrollmentTBD

Overview

one

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

MC Utrecht

•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.

•\-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;