Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
Recruiting · NCT06071507 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS San Raffaele
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
5 locations listed.
- Acibadem Maslak Hospital - Istanbul, Turkey (Türkiye)
- IRCCS San Raffaele Scientific Institute - Milan, Italy
- ISMETT - University of Palermo - Palermo, Italy
- Hôpital la pitié salpêtrière, APHP - Paris, France
- São João University Hospital - Porto, Portugal