Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
IRCCS San Raffaele
250 participants
Apr 15, 2024
OBSERVATIONAL
Conditions
Summary
The aim of this observational study is to compare the outcomes of three different procedures performed for the management of malignant Gastric Outlet Obstruction due to Pancreatic Cancer. Patients who undergo: * Surgical gastroenterostomy * Endoscopic placement of a self-expanding metallic stent * EUS-guided gastroenterostomy in accordance with standard clinical practice, will be enrolled to evaluate potential differences between the procedures in terms of clinical success, eating experience, chemotherapy tolerance, and nutritional status during follow-up. Participants will be asked to complete a quality of life questionnaire at baseline and during follow-up; however, no additional procedures will be conducted as a result of participation in the study.
Eligibility
Inclusion Criteria4
- cyto-/histo-logically confirmed pancreatic cancer
- a maximum of 6 months from pancreatic cancer diagnosis and candidate to active treatment
- stenosis causing gastric outlet obstruction (GOO) due to neoplastic invasion/compression confirmed by radiology or endoscopy extending from the distal one third of the stomach or the duodenum
- patients candidate to either ES or EUS-GE or s-GE
Exclusion Criteria9
- age \< 18 years
- patients with benign or indeterminate gastrointestinal stenosis
- patients with malignant GOO (mGOO) from neoplasia other than pancreatic cancer
- candidates to upfront surgical resection or who already received curative pancreatic resection
- patients who already received a treatment for mGOO
- patients receiving an additional procedure for biliary drainage which might increase the risk of adverse events or hamper the assessment of quality of life; biliary drainage will be allowed if performed uneventfully (without adverse events) at least one day (endoscopic drainage) or one month (surgical hepaticojejunostomy) before mGOO treatment;
- patients carrying any percutaneous drainage (such as percutaneous transhepatic biliary drainage or ascites drainage).
- inability or unwillingness to sign the informed consent form (ICF)
- contraindications to any active palliation of the mGOO, or indication to palliation through venting gastrostomy or nasogastric tube placement alone
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06071507