Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Clinical Success [Срок оценки: 30 days]

Вторичные конечные точки (5)

• Eating Experience [Срок оценки: 3 months]
• Chemotherapy Tolerance [Срок оценки: 24 months]
• Body Mass Index [Срок оценки: 6 months]
• Body Composition [Срок оценки: 6 months]
• Nutritional status [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 2 центра

• IRCCS San Raffaele Scientific Institute — Milan
• ISMETT - University of Palermo — Palermo

Франция · 1 центр

• Hôpital la pitié salpêtrière, APHP — Paris

Португалия · 1 центр

• São João University Hospital — Porto

Turkey (Türkiye) · 1 центр

• Acibadem Maslak Hospital — Istanbul

Публикации

• 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
• 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: 10.105 PMID 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: 10.10 PMID 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):1803-181 PMID 34121130

Идентификаторы

NCT: NCT06071507 · GOOSE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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