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Gastric Outlet ObstructionGOOSENCT06071507

Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

An observational study of Gastric Outlet Obstruction and Pancreatic Cancer, run by IRCCS San Raffaele at 5 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Outlet Obstruction, Pancreatic Cancer
How many people
250 participants
Where
5 sitesin 4 countries
Study dates
15 Apr 2024to Dec 2027
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Giuseppe Vanella, MD contact

+390226439574

vanella.giuseppe@hsr.it

Laura Apadula contact

apadula.laura@hsr.it

5 sites in 4 countries

Italy2 sites, 2 recruiting

  • IRCCS San Raffaele Scientific Institute

    Milan, 20132

    Giuseppe Vanella, MD, +390226439574, vanella.giuseppe@hsr.it

    Recruiting

  • ISMETT - University of Palermo

    Palermo

    Giacomo Rizzo

    Not yet recruiting

Other trials in Italy

France1 site, 1 recruiting

  • Hôpital la pitié salpêtrière, APHP

    Paris

    Charles De Ponthaud

    Sebastien Gaujoux

    Not yet recruiting

Other trials in France

Portugal1 site, 1 recruiting

  • São João University Hospital

    Porto

    Filipe Vilas Boas Silva

    Not yet recruiting

Other trials in Portugal

Turkey (Türkiye)1 site, 1 recruiting

  • Acibadem Maslak Hospital

    Istanbul

    Bahadir Bozkırlı

    Not yet recruiting

Other trials in Turkey (Türkiye)

About this study

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:

Read more
  • 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.

Read the 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.

Keywords
Enteral stent, Duodenal stent, Gastroenterostomy, EUS, Bypass, LAMS, Gastrojejunostomy
Medical subject headings
Gastric Outlet Obstruction, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06071507
Study groupRoleWhat they receive
Enteral StentingEndoscopic 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 GastrojejunostomyThe 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 GastrojejunostomyThe procedure implies a surgical anastomosis between gastric wall and a jejunal loop. The procedure can be performed either through laparoscopy or open surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days

Secondary outcomes (5)

  1. Eating Experience

    Mean difference in the Anorexia Cachexia subscale of the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) scale between pre- and post-procedure

    Measured: 3 months

  2. Chemotherapy Tolerance

    Delay or discontinuation of an intended chemotherapy regimen

    Measured: 24 months

  3. Body Mass Index

    A numerical value calculated by dividing a person's weight in kilograms by the square of their height in meters

    Measured: 6 months

  4. Body Composition

    Muscle area calculated using CT scans using dedicated software

    Measured: 6 months

  5. Nutritional status

    Evaluated through the Prognostic Nutritional Index, using biochemical values stardardly evaluated during chemotherapy

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2023
  2. Study start15 Apr 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06071507
Sponsor's protocol ID
GOOSE
Acronym
GOOSE
Status last verified
Jan 2026
First submitted
1 Oct 2023
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20003966

  • 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.

    PubMed 35325931

  • 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.

    PubMed 33852900

  • 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.

    PubMed 34121130

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Outlet Obstruction and Pancreatic Cancer, run by IRCCS San Raffaele at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy, France, Portugal, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giuseppe Vanella, MD (+390226439574, vanella.giuseppe@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Success (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06071507, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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