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Recruiting Observational

Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

NCT06071507 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2024-04-15
Last updated
2026-01-15

Condition(s) studied

Gastric Outlet ObstructionPancreatic Cancer

Study 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 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Clinical Success — 30 days
    A Gastric Outlet Obstruction Scoring System (GOOSS) \>/= 2 after the initial intervention, corresponding to the ability to eat at least soft solids

Trial sites (5)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06071507 on ClinicalTrials.gov ↗ ← All trials in Turkey