Actively Recruiting

Age: 18Years +
All Genders
NCT06071507

Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

Led by IRCCS San Raffaele · Updated on 2026-01-15

250

Participants Needed

5

Research Sites

189 weeks

Total Duration

On this page

Sponsors

I

IRCCS San Raffaele

Lead Sponsor

E

European Pancreatic Club

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed pancreatic cancer by cytology or histology
  • Diagnosis of pancreatic cancer within the last 6 months and candidate for active treatment
  • Gastric outlet obstruction caused by tumor invasion or compression confirmed by imaging or endoscopy
  • Candidate for one of the following procedures: endoscopic stent placement, EUS-guided gastroenterostomy, or surgical gastroenterostomy
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Benign or unclear gastrointestinal stenosis
  • Gastric outlet obstruction caused by cancers other than pancreatic cancer
  • Candidates for upfront surgical resection or those who already had curative pancreatic surgery
  • Prior treatment for malignant gastric outlet obstruction
  • Receiving additional biliary drainage procedures that increase risk or affect quality-of-life assessment, except uneventful biliary drainage done at least one day (endoscopic) or one month (surgical) before treatment
  • Having any type of percutaneous drainage like biliary or ascites drainage
  • Unable or unwilling to provide informed consent
  • Contraindications to active palliation of malignant gastric outlet obstruction or requiring only venting gastrostomy or nasogastric tube palliation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Hôpital la pitié salpêtrière, APHP

Paris, France

Not Yet Recruiting

2

IRCCS San Raffaele Scientific Institute

Milan, Italy, 20132

Actively Recruiting

3

ISMETT - University of Palermo

Palermo, Italy

Not Yet Recruiting

4

São João University Hospital

Porto, Portugal

Not Yet Recruiting

5

Acibadem Maslak Hospital

Istanbul, Turkey (Türkiye)

Not Yet Recruiting

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Research Team

G

Giuseppe Vanella, MD

CONTACT

L

Laura Apadula

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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