Comparing treatments for malignant gastric outlet obstruction caused by pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare the outcomes of three different procedures for managing malignant gastric outlet obstruction (GOO) due to pancreatic cancer. Patients will undergo surgical gastroenterostomy, endoscopic placement of a self-expanding metallic stent, or EUS-guided gastroenterostomy, with their clinical success, eating experience, chemotherapy tolerance, and nutritional status evaluated during follow-up. Participants will complete quality of life questionnaires at baseline and during follow-up, although no additional procedures will be performed as part of the study.

Why it matters

Who can join: the full rules

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's running

• IRCCS San Raffaele Scientific Institute
  Milan, Italy Recruiting
• Hôpital la pitié salpêtrière, APHP
  Paris, France Not yet recruiting
• ISMETT - University of Palermo
  Palermo, Italy Not yet recruiting
• São João University Hospital
  Porto, Portugal Not yet recruiting
• Acibadem Maslak Hospital
  Istanbul, Turkey (Türkiye) Not yet recruiting

Study contacts

• Principal investigator: Giuseppe Vanella, MD — IRCCS San Raffaele
• Study coordinator: Giuseppe Vanella, MD
• Email: vanella.giuseppe@hsr.it
• Phone: +390226439574

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.