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Идёт набор NCT06867172

Prevalence of Pancreatic Steatosis in Pancreatic Cystic Neoplasms and Pancreatic Adenocarcinoma

— Наблюдательное Pancreatic Steatosis Pancreatic Cyst Pancreatic Adenocarcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: computerized tomography, Endosonography (EUS).
Кому может быть актуально
Состояния в реестре: Pancreatic Steatosis, Pancreatic Cyst, Pancreatic Adenocarcinoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Румыния
Следующий шаг
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Официальное название

The Emerging Issue - Pancreatic Steatosis Prevalence in Pancreatic Cystic Neoplasms and Adenocarcinoma: Insights From a Single-center Retrospective Study

Обзор

Several pancreatic neoplastic cystic lesions, such as IPMN (intrapapilary mucinous neoplasia), cystic neuroendocrine tumors (NET) and mucinous neoplasms, present a carcinogenetic risk, though it is yet unknown if this risk is increased in patients with pancreatic steatosis (PS). The primary objective of the study is to determine de prevalence of pancreatic steatosis in pancreatic neoplastic cysts and if pancreatic steatosis is increased in those lesions that pose a carcinogenetic risk. The secondary objective is to evaluate the prevalence of pancreatic steatosis in pancreatic adenocarcinoma.

Подробное описание

Pancreatic steatosis has gained significant novel interest in the pathophysiology of PDAC and neoplastic cystic lesions. Pancreatic steatosis is the new emerging issue in pancreatology. Recently, pancreatic steatosis has gained significant novel interest in the pathophysiology of PDAC.

The primary objective of the study is to determine de prevalence of pancreatic steatosis in pancreatic neoplastic cysts and if pancreatic steatosis is increased in those lesions that pose a carcinogenetic risk.

Pancreatic ductal adenocarcinoma (PDAC) has a poor survival, predominantly as a result of its diagnosis in advanced stages. Pathological changes of steatosis are an independent determinant of PDAC, and these pathological changes are correlated with the attenuation of the pancreas on computed tomography (CT). The secondary objective is to evaluate the prevalence of pancreatic steatosis in pancreatic adenocarcinoma.

Вмешательства

  • Диагностический тест computerized tomography
    Little is known about the prevalence of pancreatic steatosis in patients with pancreatic cystic lesions therefore this observational study aims to clarify the data.
  • Диагностический тест Endosonography (EUS)
    EUS can better evaluate all pancreatic cysts, therefore is mandatory in this observational study.

Первичные конечные точки

  • increased prevalence of pancreatic steatosis in neoplastic cystic lesions [Срок оценки: From enrollment up to 5 years]
Вторичные конечные точки (1)
  • Increased prevalence of pancreatic steatosis in PDAC [Срок оценки: From enrollment up to 5 years]

Критерии участия

Критерии включения

  • Age 18 or older
  • Patients with at least 1 pancreatic cystic lesion based on CT and EUS features, with a cyst size ≥ 5mm; or healthy subjects or PDAC (confirmed by histopathological exam).

Критерии исключения

  • No evidence of written informed consent
  • Patients with contraindications for endoscopy due to comorbidities
  • Metal stent in hepato-bilio-pancreatic region at time of baseline CT-imaging (vascular, luminal and biliary)
  • Acute pancreatitis at baseline imaging
  • Pancreatic surgery at baseline imaging in our department
  • Splenectomy
  • Patients with significant alcohol consumption, defined as alcohol intake of over 20 g daily (140 g weekly) for men and 10 g daily (70 g weekly) for women

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Румыния · 1 центр
  • Prof Dr Agrippa Ionescu; Clinical Emergency Hospital — Bucharest

Публикации

  • Rebours V, Gaujoux S, d'Assignies G, Sauvanet A, Ruszniewski P, Levy P, Paradis V, Bedossa P, Couvelard A. Obesity and Fatty Pancreatic Infiltration Are Risk Factors for Pancreatic Precancerous Lesions (PanIN). Clin Cancer Res. 2015 Aug 1;21(15):3522-8. doi: 10.1158/1078-0432.CCR-14-2385. Epub 2015 Feb 19. PMID 25700304
  • Kashiwagi K, Seino T, Fukuhara S, Minami K, Horibe M, Iwasaki E, Takaishi H, Itoh K, Sugino Y, Inoue N, Iwao Y, Kanai T. Pancreatic Fat Content Detected by Computed Tomography and Its Significant Relationship With Intraductal Papillary Mucinous Neoplasm. Pancreas. 2018 Oct;47(9):1087-1092. doi: 10.1097/MPA.0000000000001103. PMID 30028443

Идентификаторы

NCT: NCT06867172 · 346833

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗