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Набор скоро начнётся NCT07607912

Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus

— Наблюдательное Diabetes Mellitus Type 2 Pancreatectomy Pancreatic Neoplasms

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus Type 2, Pancreatectomy, Pancreatic Neoplasms. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus: A Monocentric Ambispective Observational Study

Обзор

This study will examine how removal of part or all of the pancreas affects blood sugar control, metabolism, and clinical outcomes over time. The study will include adults with diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS. Researchers will study whether glycemic control worsens after surgery and whether this risk changes according to the type of pancreatic resection. The study will also examine changes in glucose metabolism, and cancer-related outcomes. Information from routine clinical care, metabolic tests, imaging, and pancreatic tissue samples collected during surgery may be used for research analyses.

Подробное описание

Pancreatic surgery can lead to substantial changes in glucose metabolism because removal of pancreatic tissue reduces endocrine pancreatic mass and may affect insulin secretion, insulin sensitivity, and hormone regulation. In individuals with preoperative diabetes mellitus, pancreatic resection may further worsen glycemic control, increase treatment requirements, and contribute to heterogeneous metabolic trajectories after surgery.

This monocentric ambispective observational study will evaluate the clinical, metabolic, and oncological consequences of partial, near-total, and total pancreatectomy in adults with preoperative diabetes mellitus undergoing pancreatic surgery at Fondazione Policlinico Universitario A. Gemelli IRCCS.

The primary objective is to assess worsening of glycemic control 12 months after surgery according to the type of pancreatic resection. Secondary objectives include evaluation of longitudinal metabolic changes, diabetes treatment intensification, metabolic phenotypes before surgery, associations between preoperative metabolic characteristics and postoperative outcomes, and exploratory analyses of oncological outcomes including overall survival and disease-free survival.

The study integrates retrospective, ambispective, and prospective cohorts. Data collected as part of routine clinical care may include clinical and surgical information, laboratory data, imaging, oral glucose tolerance tests (OGTT), mixed meal tests (MMT), and metabolic clamp studies when available. Pancreatic tissue obtained from surgical specimens may also be used for histopathological, morphological, and molecular analyses to investigate relationships between pancreatic tissue characteristics, intrapancreatic fat, metabolic phenotypes, and clinical outcomes.

Первичные конечные точки

  • Worsening of Glycemic Control After Pancreatectomy [Срок оценки: Within 12 months after surgery]

Критерии участия

Критерии включения

  • Adult patients (≥18 years)
  • Diabetes mellitus at baseline
  • Undergoing partial, near-total, or total pancreatectomy at the study center for benign or malignant pancreatic disease
  • Availability of clinical and metabolic follow-up data according to study component
  • Written informed consent for the ambispective and prospective components, where applicable

Критерии исключения

  • Age <18 years
  • Absence of diabetes mellitus at baseline
  • Missing essential clinical data or incomplete follow-up precluding evaluation of study outcomes
  • Severe pre-existing non-oncologic clinical conditions with life expectancy <6 months
  • Refusal, withdrawal, or inability to provide informed consent for the ambispective and prospective components, where applicable

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07607912 · 27417 · EFSD08-EL25-1419-TM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗