Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital la pitié salpêtrière, APHP
NOT_YET_RECRUITING
Paris
Italy
IRCCS San Raffaele Scientific Institute
RECRUITING
Milan
ISMETT - University of Palermo
NOT_YET_RECRUITING
Palermo
Portugal
São João University Hospital
NOT_YET_RECRUITING
Porto
Turkey
Acibadem Maslak Hospital
NOT_YET_RECRUITING
Istanbul
Contact Information
Primary
Giuseppe Vanella, MD
vanella.giuseppe@hsr.it
+390226439574
Backup
Laura Apadula
apadula.laura@hsr.it
Time Frame
Start Date: 2024-04-15
Estimated Completion Date: 2027-12
Participants
Target number of participants: 250
Treatments
Enteral Stenting
Endoscopic placement of enteral Self-Expandable Metal Stents (SEMS). The procedure implies endoscopic identification of the stricture, placement of a guidewire through the stricture and placement of a SEMS through the stricture under fluoroscopic control.
EUS-guided Gastrojejunostomy
The procedure implies distention of the jejunal loop and EUS-guided placement of an electrocautery-enhanced (EC) LAMS connecting the stomach to a jejunal loop distal to the stenosis. Any technique for EUS-GE will be allowed, provided that an EC-LAMS \>15mm will be used.
Surgical Gastrojejunostomy
The procedure implies a surgical anastomosis between gastric wall and a jejunal loop. The procedure can be performed either through laparoscopy or open surgery.
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele
Collaborators: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, European Pancreatic Club

This content was sourced from clinicaltrials.gov