Status:
RECRUITING
Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
European Pancreatic Club
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Conditions:
Gastric Outlet Obstruction
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Brief 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 wh...
Detailed Description
Gastric Outlet Obstruction (GOO) syndrome is a frequent complication of biliopancreatic and gastroduodenal neoplasms and manifests with recurrent vomiting, dehydration and malnutrition, seriously comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06071507
Start Date
April 15 2024
End Date
December 1 2027
Last Update
April 18 2024
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital la pitié salpêtrière, APHP
Paris, France
2
IRCCS San Raffaele Scientific Institute
Milan, Italy, 20132
3
ISMETT - University of Palermo
Palermo, Italy
4
São João University Hospital
Porto, Portugal