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
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Brief Title
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Your Study Journey
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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
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
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
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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.
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...
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...
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...