Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

Pancreatic Cancer Clinical Trial

— GOOSE  

Official title:

Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06071507
• Other study ID #: GOOSE
• Status: Recruiting
• Start date: April 15, 2024
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele
• Contact: Giuseppe Vanella, MD
• Phone: +390226439574
• Email: vanella.giuseppe[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pancreatic Cancer
• Pyloric Stenosis

Locations

Country	Name	City	State
France	Hôpital la pitié salpêtrière, APHP	Paris
Italy	IRCCS San Raffaele Scientific Institute	Milan
Italy	ISMETT - University of Palermo	Palermo
Portugal	São João University Hospital	Porto
Turkey	Acibadem Maslak Hospital	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS San Raffaele	European Pancreatic Club, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Countries where clinical trial is conducted

France,  Italy,  Portugal,  Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Technical Success	completion of the intended procedure	Day 0
Other	Full diet	GOOSS >/= 3, that is the possibility to eat a full diet	3 months
Other	Adverse events	Any post-procedural undesirable event requiring an escalation of medical care (additional investigations or treatments, including medical therapy)	30 days
Other	Symptoms recurrence	Persistent recurrence of obstructing symptoms (GOOS Score	24 months
Other	Overall Survival		24 months
Primary	Clinical Success	A Gastric Outlet Obstruction Scoring System (GOOSS) >/= 2 after the initial intervention, corresponding to the ability to eat at least soft solids	30 days
Secondary	Eating Experience	Mean difference in the Anorexia Cachexia subscale of the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) scale between pre- and post-procedure	3 months
Secondary	Chemotherapy Tolerance	Delay or discontinuation of an intended chemotherapy regimen	24 months
Secondary	Body Mass Index	A numerical value calculated by dividing a person's weight in kilograms by the square of their height in meters	6 months
Secondary	Body Composition	Muscle area calculated using CT scans using dedicated software	6 months
Secondary	Nutritional status	Evaluated through the Prognostic Nutritional Index, using biochemical values stardardly evaluated during chemotherapy	6 months