Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
250 Participants
are grouped into 3 trial groupsSponsors and collaborators
IRCCS San Raffaele
Lead sponsor
European Pancreatic Club
Collaborator
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Collaborator
Source ClinicalTrials.gov