Clinical trial NCT06071507: Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
Official title: Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Outlet Obstruction
Pancreatic Cancer
Keywords: Enteral stent
Duodenal stent
Gastroenterostomy
EUS
Bypass
LAMS
Gastrojejunostomy
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: European Pancreatic Club
name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
First posted: 2023-10-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Success
timeFrame: 30 days
Secondary outcomes:
measure: Eating Experience
timeFrame: 3 months
measure: Chemotherapy Tolerance
timeFrame: 24 months
measure: Body Mass Index
timeFrame: 6 months
measure: Body Composition
timeFrame: 6 months
measure: Nutritional status
timeFrame: 6 months
Other outcomes:
measure: Technical Success
timeFrame: Day 0
measure: Full diet
timeFrame: 3 months
measure: Adverse events
timeFrame: 30 days
measure: Symptoms recurrence
timeFrame: 24 months
measure: Overall Survival
timeFrame: 24 months
Locations:
city: Paris
country: France
facility: Hôpital la pitié salpêtrière, APHP
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
city: Palermo
country: Italy
facility: ISMETT - University of Palermo
city: Porto
country: Portugal
facility: São João University Hospital
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
Study officials:
affiliation: IRCCS San Raffaele
name: Giuseppe Vanella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Raffaele
name: Gabriele Capurso, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.