Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy — GOOSE  

Pancreatic Cancer Clinical Trial

Official title: Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Gastric Outlet Obstruction (GOO) syndrome is a frequent complication of biliopancreatic and gastroduodenal neoplasms and manifests with recurrent vomiting, dehydration and malnutrition, seriously compromising quality of life and the ability to tolerate chemotherapy.

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. ;

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pancreatic Cancer
• Pyloric Stenosis

• NCT number: NCT06071507
• Study type: Observational [Patient Registry]
• Source: IRCCS San Raffaele
• Contact: Giuseppe Vanella, MD
• Phone: +390226439574
• Email: vanella.giuseppe@hsr.it
• Status: Recruiting
• Start date: April 15, 2024
• Completion date: December 2027