Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
NCT ID: NCT06071507
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
250 participants
OBSERVATIONAL
2024-04-15
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pancreas Resection for Colorectal Metastasis: Retrospective Study
NCT05714475
Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
NCT02479984
68Ga-DOTATOC Radio-Guided Surgery With β-Probe in GEP-NET
NCT05448157
Generation of Organoids of Neuroendocrine Neoplasms of the Gastro-Entero-Pancreatic Tract Obtained From Patients Undergoing Surgery
NCT06519500
Cohort Study on Nutritional, Metabolic, and Volumetric Assessment After Pancreaticoduodenectomy
NCT07159672
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Standard treatment options for GOO are surgical gastroenterostomy (S-GE) or endoscopic placement of a self-expanding metallic stent (ES): surgical treatment achieves better long-term results at the cost of a more invasive procedure. The advances of therapeutic endosonography (EUS) have provided a new possibility to resolve this condition through EUS-guided gastroenterostomy (EUS-GE). The latter involves the creation of a gastroenteric bypass by endoscopically positioning a lumen-apposing metal stent (LAMS). Recent evidence has shown several advantages over previous treatments, in terms of less invasiveness compared to surgery and greater long-term efficacy compared to enteral stenting. However, most of the evidence comes from retrospective protocols and heterogeneous studies that include different neoplasms and clinical courses. Furthermore, the definition of clinical success in the current literature refers to the resolution of the mechanical obstruction of the syndrome, without any in-depth study on the clinical impact of different management strategies in terms of more complex outcomes, such as survival, quality of life, nutritional status and chemotherapy tolerance.
The aim of this study is to prospectively analyze the long-term clinical impact of GOO management strategies in a homogeneous cohort of patients with pancreatic adenocarcinoma (PC) and recent disease diagnosis.
The design of this study is:
* Observational
* Prospective
* Multicentric
* Comparative (3-arms)
No changes to the current clinical practice of the participating centers are foreseen. Each center will candidate the enrolled patient to the procedure that is routinely and currently used in that clinical scenario at their own center. Enrollment in the protocol does not require additional investigations or treatments, except for the administration of quality-of-life questionnaires. Participation in the study implies sharing of information standardly collected during the oncological journey. The prospective follow-up will address clinical efficacy, safety and patient-reported experience, including assessment of the eating experience, chemotherapy tolerance and nutritional status.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Pancreatic Club
UNKNOWN
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
OTHER
IRCCS San Raffaele
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Giuseppe Vanella
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giuseppe Vanella, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele
Gabriele Capurso, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital la pitié salpêtrière, APHP
Paris, , France
IRCCS San Raffaele Scientific Institute
Milan, , Italy
ISMETT - University of Palermo
Palermo, , Italy
São João University Hospital
Porto, , Portugal
Acibadem Maslak Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Charles De Ponthaud
Role: primary
Sebastien Gaujoux
Role: backup
Giacomo Rizzo
Role: primary
Filipe Vilas Boas Silva
Role: primary
Bahadir Bozkırlı
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Jeurnink SM, Steyerberg EW, van Hooft JE, van Eijck CH, Schwartz MP, Vleggaar FP, Kuipers EJ, Siersema PD; Dutch SUSTENT Study Group. Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial. Gastrointest Endosc. 2010 Mar;71(3):490-9. doi: 10.1016/j.gie.2009.09.042. Epub 2009 Dec 8.
van Wanrooij RLJ, Vanella G, Bronswijk M, de Gooyer P, Laleman W, van Malenstein H, Mandarino FV, Dell'Anna G, Fockens P, Arcidiacono PG, van der Merwe SW, Voermans RP. Endoscopic ultrasound-guided gastroenterostomy versus duodenal stenting for malignant gastric outlet obstruction: an international, multicenter, propensity score-matched comparison. Endoscopy. 2022 Nov;54(11):1023-1031. doi: 10.1055/a-1782-7568. Epub 2022 Mar 24.
Bronswijk M, Vanella G, van Malenstein H, Laleman W, Jaekers J, Topal B, Daams F, Besselink MG, Arcidiacono PG, Voermans RP, Fockens P, Larghi A, van Wanrooij RLJ, Van der Merwe SW. Laparoscopic versus EUS-guided gastroenterostomy for gastric outlet obstruction: an international multicenter propensity score-matched comparison (with video). Gastrointest Endosc. 2021 Sep;94(3):526-536.e2. doi: 10.1016/j.gie.2021.04.006. Epub 2021 Apr 20.
Boghossian MB, Funari MP, De Moura DTH, McCarty TR, Sagae VMT, Chen YI, Mendieta PJO, Neto FLP, Bernardo WM, Dos Santos MEL, Chaves FT, Khashab MA, de Moura EGH. EUS-guided gastroenterostomy versus duodenal stent placement and surgical gastrojejunostomy for the palliation of malignant gastric outlet obstruction: a systematic review and meta-analysis. Langenbecks Arch Surg. 2021 Sep;406(6):1803-1817. doi: 10.1007/s00423-021-02215-8. Epub 2021 Jun 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GOOSE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.