Invasive Intervention of Local Complications of Acute Pancreatitis

Официальное название

Drainage and Debridement of Local Complications of Acute Pancreatitis: A Single-center Real-world Prospective Study

Обзор

Strategies for invasive intervention in acute pancreatitis include sequential or combined use of multiple drainage and debridement modalities. The more widely used is the step-up approach, which requires an individualized and multidisciplinary (internal medicine, interventional radiology, endoscopy, surgery, critical care medicine, and nutritionists) approach. The available evidence from randomized controlled studies is from highly selected subject populations, and it is unclear whether the results can be applied to complex clinical situations in real clinics, and the optimal strategy for drainage of peripancreatic lesions in different patients still needs to be evaluated in the real world. This study intends to establish a prospective single-center cohort for real-world analysis to collect comprehensive clinic information and clinical outcomes, to evaluate the effectiveness and safety of existing intervention strategies, especially the timing and modality of interventions, in real-world clinical practice, and to explore the key factors affecting patient prognosis.

Вмешательства

• Процедура Invasive intervention for acute pancreatitis
  Invasive interventions include drainage (endoscopic transmural drainage, imaging-guided percutaneous catheter drainage) and debridement (endoscopic debridement, videoscopic assisted retroperitoneal debridement, laparoscopic surgical debridement, open surgical debridement).

Первичные конечные точки

• Major complications or death [Срок оценки: Day 1 from admission until 6 months after discharge]

Вторичные конечные точки (11)

• Organ failure [Срок оценки: Day 1 from admission until 6 months after discharge]
• Systemic complication [Срок оценки: Day 1 from admission until 6 months after discharge]
• Enterocutaneous fistula [Срок оценки: Day 1 from admission until 6 months after discharge]
• Perforation of visceral organ [Срок оценки: Day 1 from admission until 6 months after discharge]
• Intraabdominal bleeding [Срок оценки: Day 1 from admission until 6 months after discharge]
• Pancreatic fistula [Срок оценки: Day 1 from admission until 6 months after discharge]
• New-onset diabetes [Срок оценки: Day 1 from admission until 6 months after discharge]
• Use of pancreatic enzymes [Срок оценки: Day 1 from admission until 6 months after discharge]
• Length of hospitalization [Срок оценки: Day 1 from admission until the 1 day of discharge]
• Length of intesive care [Срок оценки: Day 1 from admission until the 1 day of discharge]
• Total direct medical costs and indirect costs [Срок оценки: Day 1 from admission until the 1 day of discharge]

Критерии участия

Критерии включения

• Admission diagnosis of acute pancreatitis;
• Localized complications confirmed by imaging examinations;
• Voluntary participation in the study and signing of an informed consent form.

Критерии исключения

• Improved with conservative treatment without invasive interventions for local complications during hospitalization.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT06023771 · K4433

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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