Идёт набор NCT06391359

Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2)

Без фазы С лечением Idiopathic Acute Pancreatitis

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: Laparoscopic cholecystectomy, Watchful waiting.
Кому может быть актуально: Состояния в реестре: Idiopathic Acute Pancreatitis. 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: Нидерланды
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

Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2): a Multicenter Randomized Trial

Обзор

Rationale: Annually, acute pancreatitis is diagnosed in 6,500 patients in the Netherlands. In up to 25% of patients no definitive cause can be determined after routine work-up including endoscopic ultrasound and this is deemed to be idiopathic acute pancreatitis (IAP). IAP is known for its high recurrence rate. It is hypothesized that microlithiasis, a type of biliary pancreatitis, is the most common cause of IAP. Laparoscopic cholecystectomy (LC) is highly effective in preventing recurrence of biliary pancreatitis. Currently no randomized trial has compared LC with conservative treatment in patients with IAP after adequate work-up including endoscopic ultrasound. Objective: To assess the effectiveness of LC as compared to conservative treatment in patients after a first, second or third episode of an 'EUS-negative' IAP. Study design: Multicenter randomized controlled trial. Patients will be followed for one year after randomization. Study population: Adults with a first, second or third episode of IAP, of which at least one episode is characterized by a 'negative EUS'. Intervention (if applicable): Laparoscopic cholecystectomy versus conservative treatment. Main study parameters/endpoints: The primary endpoint is pancreatitis recurrence. Secondary endpoints include occurrence of biliary events, complications of LC, number and severity of recurrent episodes of pancreatitis, quality of life (QALY), costs (hospital and societal) and cost-effectiveness.

Вмешательства

Процедура Laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Другое Watchful waiting
Watchful waiting

Первичные конечные точки

Acute pancreatitis recurrence [Срок оценки: Within 1 year after date of inclusion]

Критерии участия

Критерии включения

At least 18 years old
Eligible for early (laparoscopic)\* cholecystectomy
Full required diagnostic work-up of patient has been performed, including EUS
First, second or third episode of IAP, of which at least one episode characterized by a 'negative-EUS'' result
Informed consent for participation was obtained \*if required open cholecystectomy is allowed