NCT06071507Recruiting
Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 1 Oct 2023
- Start date
- 15 Apr 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Pancreatic cancer
- NCT number
- NCT06071507
What you commit to
- Study type: Observational
- Planned participants: 250
- From 15 Apr 2024 to the primary completion date, Dec 2026
- 5 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- patients with malignant GOO (mGOO) from neoplasia other than pancreatic cancer
Age
- age \< 18 years
Other
- patients with benign or indeterminate gastrointestinal stenosis
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital la pitié salpêtrière, APHP Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| IRCCS San Raffaele Scientific Institute Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ISMETT - University of Palermo Coordinator of this site? Confirm its status | Palermo | Italy | Not yet recruiting |
| São João University Hospital Coordinator of this site? Confirm its status | Porto | Portugal | Not yet recruiting |
| Acibadem Maslak Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.