Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

NCT06071507 | Recruiting

• 1 other identifier: GOOSE
• Study Type: observational
• Target: 250
• Locations: 4 countries
• Sites: 5

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.

Conditions

Gastric Outlet Obstruction; Pancreatic Cancer

Keywords

Enteral stent; Duodenal stent; Gastroenterostomy; EUS; Bypass; LAMS; Gastrojejunostomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Eating Experience

  3 months

• Chemotherapy Tolerance

  24 months

• Body Mass Index

  6 months

• Body Composition

  6 months

• Nutritional status

  6 months

Other Outcomes (5)

• Technical Success

  Day 0

• Full diet

  3 months

• Adverse events

  30 days

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A homogeneous population of patients with pathologically confirmed Pancreatic Cancer, candidate to palliation of Gastric Outlet Obstruction and active oncological treatment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• European Pancreatic Club: collaborator
• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: collaborator

Study Sites (5)

Hôpital la pitié salpêtrière, APHP

Paris, France

NOT YET RECRUITING

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

RECRUITING

ISMETT - University of Palermo

Palermo, Italy

NOT YET RECRUITING

São João University Hospital

Porto, Portugal

NOT YET RECRUITING

Acibadem Maslak Hospital

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

Related Publications (4)

• 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.

  PMID: 20003966 BACKGROUND

• 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.

  PMID: 35325931 BACKGROUND

• 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.

  PMID: 33852900 BACKGROUND

• 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.

  PMID: 34121130 BACKGROUND

MeSH Terms

Conditions

Gastric Outlet Obstruction; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Giuseppe Vanella, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

• Gabriele Capurso, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Vanella, MD

CONTACT

+390226439574; vanella.giuseppe@hsr.it

Laura Apadula

CONTACT

apadula.laura@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 6, 2023
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); TU (1); IT (2); PT (1)