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Идёт набор NCT07413068

Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis

— Наблюдательное Cholelithiasis Associated With Common Bile Duct Stones

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: endoscopic transpapillary gallbladder-preserving, ERCP plus Laparoscopic Cholecystectomy, Conservative treatment.
Кому может быть актуально
Состояния в реестре: Cholelithiasis Associated With Common Bile Duct Stones. 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
Китай
Следующий шаг
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Официальное название

Comparative Study of ERCP, ERCP Plus Laparoscopic Cholecystectomy, and Conservative Management in Patients With Concomitant Choledocholithiasis and Cholecystolithiasis.

Обзор

Recruit patients with cholelithiasis with concomitant choledocholithiasis into the cohort, and assign them to undergo endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment based on patient preference. Collect clinical data and patient-reported outcomes regularly at baseline and during follow-up in the cohort. Assess the clinical safety of ERCP-GPC and LC by evaluating the clinical success rate of treatment as well as the incidence of short-term and long-term postoperative complications; investigate the efficacy differences among endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment in managing cholelithiasis with concomitant choledocholithiasis.

Вмешательства

  • Процедура endoscopic transpapillary gallbladder-preserving
    Based on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving
  • Процедура ERCP plus Laparoscopic Cholecystectomy
    Based on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy
  • Препарат Conservative treatment
    Based on the patient's preference, they will receive the following treatment：ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.

Первичные конечные точки

  • Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications. [Срок оценки: From enrollment to 3 years after the end of treatment]
Вторичные конечные точки (2)
  • Investigate the differences in efficacy among endoscopic transpapillary gallbladder-preserving cholecystolithotomy , ERCP plus laparoscopic cholecystectomy and conservative treament in managing cholelithiasis with concomitant choledocholithiasis. [Срок оценки: From enrollment to 3 years after the end of treatment]
  • Conduct a comparative analysis of the economic efficiency of ERCP-GPC , LC and conservative treatment. [Срок оценки: From enrollment to 3 years after the end of treatment]

Критерии участия

Критерии включения

  • Patients over the age of 18 years;
  • Ultrasound, MRCP, or other imaging examination findings (CT/MRI) clearly indicate a diagnosis of cholelithiasis with concomitant choledocholithiasis;
  • Patients with no history of gastrointestinal reconstruction surgery or cholecystectomy or previous biliary tract surgery (include history of ERCP);
  • Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
  • The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
  • Voluntary provision of signed informed consent.

Критерии исключения

  • Atrophic cholecystitis; porcelain gallbladder; suspect malignant tumor of the gallbladder; stenosis of the lower segment of the common bile duct; Mirrizzi syndrome;
  • Unable to undergo endoscopic interventions for various reasons;
  • Absolute surgical contraindications, including severe hepatic, renal, cardiac and pulmonary insufficiency, history of cerebral coma and allergy to anesthesia, etc;
  • Presence of ectopic duodenal papilla or congenital pancreaticobiliary malformation;
  • Patients with severe coagulopathy, defined as an International Normalized Ratio (INR) > 1.5 or patients with significant thrombocytopenia (platelet count < 50 × 10⁹/L);
  • Pregnant women;

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
  • Qilu Hospital of Shandong University — Цзинань

Идентификаторы

NCT: NCT07413068 · 2025SDU-QILU-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗