Comparing treatments for malignant gastric outlet obstruction caused by pancreatic cancer
Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
IRCCS San Raffaele · NCT06071507
This study is testing which of three different treatments works best for people with stomach blockages caused by pancreatic cancer to see how they feel and eat afterwards.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele (other) |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Paris and 4 other locations) |
| Trial ID | NCT06071507 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed pancreatic cancer experiencing gastric outlet obstruction due to neoplastic invasion or compression.
Not a fit: Patients with benign gastrointestinal stenosis or those with malignant GOO from neoplasms other than pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective treatment option for patients suffering from malignant gastric outlet obstruction, improving their quality of life and treatment outcomes.
How similar studies have performed: While there is emerging evidence supporting EUS-guided gastroenterostomy, most prior studies have been retrospective, making this a novel prospective evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris and 4 other locations
- Hôpital la pitié salpêtrière, APHP — Paris, France (NOT_YET_RECRUITING)
- IRCCS San Raffaele Scientific Institute — Milan, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Outlet Obstruction, Pancreatic Cancer, Enteral stent, Duodenal stent, Gastroenterostomy, EUS, Bypass, LAMS