Actively Recruiting

Age: 18Years +
All Genders
ID06071507

Management of Malignant Gastric Outlet Obstruction in Pancreatic Cancer Comparing Surgery and Endoscopy

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

250

Participants Needed

5

Research Sites

52 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

This research aims to compare the outcomes of three different procedures used to manage malignant Gastric Outlet Obstruction (GOO) caused by pancreatic cancer. GOO is a common complication in patients with biliopancreatic and gastroduodenal tumors, causing symptoms like vomiting, dehydration, and malnutrition, which can affect quality of life and chemotherapy tolerance. The study is observational, prospective, multicenter, and compares surgical gastroenterostomy, endoscopic stent placement, and EUS-guided gastroenterostomy in a uniform group of patients with recently diagnosed pancreatic adenocarcinoma. The procedures being evaluated include surgical gastrojejunostomy, which creates a surgical connection between the stomach and jejunum; endoscopic placement of self-expandable metal stents that open the obstructed area; and EUS-guided gastrojejunostomy, which uses endoscopic ultrasound to place a metal stent creating a bypass between the stomach and a jejunal loop. Each participating center will perform the procedure that is standard in their practice without additional interventions beyond the study’s assessments. Participants will complete quality of life questionnaires at the start and during follow-up visits, but no extra procedures are required due to study participation. Researchers will monitor clinical success within 30 days, eating experience over 3 months, chemotherapy tolerance over 24 months, and nutritional status including body mass index and body composition over 6 months. Data collected during routine cancer care will be shared to evaluate the clinical impact, safety, and patient experience of each treatment method.

CONDITIONS

Brief 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 diagnosis of pancreatic cancer by cytology or histology
  • Diagnosis made within the last 6 months and candidate for active treatment
  • Presence of gastric outlet obstruction caused by cancer confirmed by radiology or endoscopy
  • Candidate for one of the three procedures: endoscopic stenting, EUS-guided gastroenterostomy, or surgical gastroenterostomy
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Benign or uncertain gastrointestinal stenosis
  • Gastric outlet obstruction caused by cancers other than pancreatic cancer
  • Scheduled for or already had curative pancreatic surgery
  • Previous treatment for malignant gastric outlet obstruction
  • Undergoing additional biliary drainage procedures with risk of adverse events or affecting quality of life assessment
  • Presence of any percutaneous drainage devices
  • Unable or unwilling to provide informed consent
  • Contraindications to active palliation or need for venting gastrostomy or nasogastric tube alone

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Observational Management

Duration - Immediate procedure with follow-up assessments up to 6 months

Participants undergo one of the routine clinical procedures for malignant gastric outlet obstruction including endoscopic stenting, EUS-guided gastroenterostomy, or surgical gastroenterostomy as per standard care at their center. No additional treatments or interventions are provided by the study.

Visits aligned with routine clinical care and assessments over 6 months

Prospective Follow-up

Duration - Up to 24 months

Participants are followed prospectively to evaluate clinical outcomes including eating experience, chemotherapy tolerance, body mass index, body composition, and nutritional status.

Periodic visits for assessments up to 24 months

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

L

Laura Apadula

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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Published Research Related To This Trial

Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial.

Suzanne M Jeurnink, Ewout W Steyerberg, Jeanin E van Hooft...

https://pubmed.ncbi.nlm.nih.gov/20003966

Endoscopic ultrasound-guided gastroenterostomy versus duodenal stenting for malignant gastric outlet obstruction: an international, multicenter, propensity score-matched comparison.

Roy L J van Wanrooij, Giuseppe Vanella, Michiel Bronswijk...

https://pubmed.ncbi.nlm.nih.gov/35325931

Laparoscopic versus EUS-guided gastroenterostomy for gastric outlet obstruction: an international multicenter propensity score-matched comparison (with video).

Michiel Bronswijk, Giuseppe Vanella, Hannah van Malenstein...

https://pubmed.ncbi.nlm.nih.gov/33852900

EUS-guided gastroenterostomy versus duodenal stent placement and surgical gastrojejunostomy for the palliation of malignant gastric outlet obstruction: a systematic review and meta-analysis.

Mateus Bond Boghossian, Mateus Pereira Funari, Diogo Turiani Hourneaux De Moura...

https://pubmed.ncbi.nlm.nih.gov/34121130