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

MC Utrecht0 个研究点目标入组 96 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•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;

发起方

MC Utrecht