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Идёт набор NCT06918652

Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis

Без фазы С лечением High-risk Patients With Acute Calculous Cholecystitis (ACC)

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: Transmural ultrasound-guided gallbladder drainage, Laparoscopic cholecystectomy.
Кому может быть актуально
Состояния в реестре: High-risk Patients With Acute Calculous Cholecystitis (ACC). 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Randomized controlled trial on high-risk patients with ACC. Consecutive patients with a diagnosis of ACC, if they meet the inclusion and exclusion criteria, will be randomized to receive Laparoscopic cholecystectomy (LC) or transmural ultrasound-guided gallbladder drainage (TUGD) with lumen-apposing self-expandable metal stents (LAMSs) within 10 days from onset of symptoms. Blood cultures will be performed at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. Bile samples will be taken during the procedure for microbiological exam and culture. Blood samples will collected from all patients at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. The follow-up will be performed after 30 days and after 6 months from intervention with an outpatient medical examination.

Вмешательства

  • Процедура Transmural ultrasound-guided gallbladder drainage
    TUGD will be performed using the bi-flanged LAMSs mounted on an electrocautery-enhanced delivery system (Hot-AXIOS™) by an experienced endoscopist defined as \> 10 LAMS positioning per year. The diameter and length of the stent and the modality of placing the stent (under complete EUS view or with endoscopic or fluoroscopic guidance) will be chosen at the discretion of the endoscopist performing the procedure
  • Процедура Laparoscopic cholecystectomy
    LC will be performed by the four-trocar technique with transection of the cystic duct and cystic artery after reaching the critical view of safety. ELC will be performed by a surgeon trained and experienced in laparoscopic surgery defined as \> 5 laparoscopic procedures for ACC on a yearly basis

Первичные конечные точки

  • The primary objective of the study is to find if TUGD with LAMSs, compared to LC, has a lower inflammatory and immunologic impact on high-risk patients with ACC. [Срок оценки: baseline, pre-surgery, day 3]
Вторичные конечные точки (12)
  • difference between the plasma concentration biochemical and immunological parameters [Срок оценки: baseline, pre-surgery, day 1, day 3]
  • 30-day postoperative complication rate according to Clavien-Dindo [Срок оценки: day 30]
  • 30-day postoperative biliary complication rate [Срок оценки: day 30]
  • 30-day postoperative mortality rate [Срок оценки: day 30]
  • Intraoperative complication rate [Срок оценки: day 0]
  • Failure rate of performing the procedure [Срок оценки: day 0]
  • Operative times [Срок оценки: through study completion, an average of 2 years]
  • Postoperative length of stay (PO-LOS) [Срок оценки: through study completion, an average of 2 years]
  • Total length of stay (T-LOS) [Срок оценки: through study completion, an average of 2 years]
  • Total readmission rate within 6 months [Срок оценки: 6 Months after procedure]
  • Readmission rate within 6 months due to Gallstones Relates Events (GRE) [Срок оценки: 6 Months after procedure]
  • Outcomes of blood and bile cultures (to define the infectious state of the patient) [Срок оценки: Baseline, pre-surgery, during the surgery, day 1, day 3]

Критерии участия

Критерии включения

  • have a diagnosis of ACC as defined by 2018 Tokyo Guidelines criteria
  • be ≥ 18 years old
  • have a POSSUM PS ≥ 25
  • onset of symptoms <= 7 days before Emergency Department (ED) admission
  • provide signed and dated informed consent form
  • willing to comply with all study procedures and be available for the duration of the study
  • have an Israelian Score (IS) (Table 3) for the risk of main bile duct stones <2 or an IS =2 and an EUS or a MRCP negative for main bile duct stones

Критерии исключения

  • Pregnancy
  • Patients unwilling to undergo follow-up assessments
  • Patients diagnosed with concomitant pancreatitis
  • Acute cholecystitis not related to a gallstone etiology
  • Onset of symptoms >7 days before ED admission
  • Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
  • Previous drainage of the gallbladder
  • Biliary peritonitis

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Италия · 1 центр
  • SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo — Pavia

Идентификаторы

NCT: NCT06918652 · SETIMIHRACC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗