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

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06071507

Collaborator

European Pancreatic Club (Other), The Mediterranean Institute for Transplantation and Advanced Specialized Therapies (Other)

250

Enrollment

Locations

47.9

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Outlet Obstruction Pancreatic Cancer

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

Anticipated Study Start Date :

Nov 3, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Nov 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Clinical Success [30 days]
A Gastric Outlet Obstruction Scoring System (GOOSS) >/= 2 after the initial intervention, corresponding to the ability to eat at least soft solids

Secondary Outcome Measures

Eating Experience [3 months]
Mean difference in the Anorexia Cachexia subscale of the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) scale between pre- and post-procedure
Chemotherapy Tolerance [24 months]
Delay or discontinuation of an intended chemotherapy regimen
Body Mass Index [6 months]
A numerical value calculated by dividing a person's weight in kilograms by the square of their height in meters
Body Composition [6 months]
Muscle area calculated using CT scans using dedicated software
Nutritional status [6 months]
Evaluated through the Prognostic Nutritional Index, using biochemical values stardardly evaluated during chemotherapy

Other Outcome Measures

Technical Success [Day 0]
completion of the intended procedure
Full diet [3 months]
GOOSS >/= 3, that is the possibility to eat a full diet
Adverse events [30 days]
Any post-procedural undesirable event requiring an escalation of medical care (additional investigations or treatments, including medical therapy)
Symptoms recurrence [24 months]
Persistent recurrence of obstructing symptoms (GOOS Score </=1) after a former clinical success (GOOS Score >/=2)
Overall Survival [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

age < 18 years
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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital la pitié salpêtrière, APHP	Paris	France
2	IRCCS San Raffaele Scientific Institute	Milan	Italy	20132
3	ISMETT - University of Palermo	Palermo	Italy
4	São João University Hospital	Porto	Portugal
5	Acibadem Maslak Hospital	Istanbul	Turkey