Меню
Идёт набор NCT07517627

Optimal Timings of Laparoscopic Cholecystectomy After ERCP in Patients With Gallstones Along With CBD Stones

Без фазы С лечением 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: Early laparoscopic cholecystectomy, Delayed Laparoscopic cholecystectomy.
Кому может быть актуально
Состояния в реестре: Cholelithiasis Associated With Common Bile Duct Stones. Базовые параметры: 14 лет — 70 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
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparative Analysis of Early Versus Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography (ERCP) in Patients of Cholelithiasis With Choledocholithiasis

Обзор

This randomized controlled trial aims to compare the mean operative time and outcomes of early versus delayed laparoscopic cholecystectomy after ERCP in patients with cholelithiasis and choledocholithiasis. Patients will be randomized into two groups: early cholecystectomy (within 72 hours of ERCP) and delayed cholecystectomy (≥1 month after ERCP). Outcomes include operative time, intra-operative blood loss, hospital stay, and conversion to open cholecystectomy

Подробное описание

Gallstones are among the most common surgical problems worldwide, and up to 20% of patients with gallstones also present with stones in the common bile duct. Standard care involves clearance of bile duct stones, typically by Endoscopic Retrograde Cholangiopancreaticography (ERCP), followed by removal of the gallbladder by laparoscopic cholecystectomy (LC).

The timing of cholecystectomy after ERCP remains debated. Early LC (within 72 hours) has been associated with fewer recurrent biliary events, reduced hospital stay, and potentially easier operative conditions. However, delayed LC (after one month) continues to be widely practiced due to institutional factors and scheduling constraints.

This randomized controlled trial at Sheikh Zayed Hospital, Lahore, is designed to evaluate whether early LC after ERCP offers measurable advantages compared with delayed LC. Patients with confirmed cholelithiasis and choledocholithiasis will be randomized into two groups: early surgery and delayed surgery. The trial will provide local evidence to guide surgical practice, focusing on operative efficiency and patient recovery.

By clarifying the optimal timing of LC after ERCP in our patient population, the study aims to support evidence-based surgical decision-making, improve outcomes, and potentially reduce healthcare costs.

Вмешательства

  • Процедура Early laparoscopic cholecystectomy
    Laparoscopic removal of gall bladder within 72hours of laparoscopic cholecystectomy
  • Процедура Delayed Laparoscopic cholecystectomy
    Laparoscopic removal of gall bladder 2 weeks or more after successful ERCP

Первичные конечные точки

  • Mean Operative time [Срок оценки: During surgery]
Вторичные конечные точки (3)
  • Length of Hospital Stay [Срок оценки: From admission to discharge (up to 30 days)]
  • Intraoperative Blood Loss [Срок оценки: During Surgery]
  • Conversion to Open Cholecystectomy [Срок оценки: During Surgery]

Критерии участия

Критерии включения

  • Patients diagnosed with cholelithiasis with choledocholithiasis based on clinical and radiological findings (right subcostal pain, presence of gallstones, and dilated common bile duct on ultrasound and MRCP)
  • Age 14 to 70 years
  • Both males and females
  • Duration of symptoms less than 3 days
  • Presence of common bile duct stone with successful clearance on ERCP

Критерии исключения

  • Features suggestive of malignancy on imaging
  • Patients who develop severe pancreatitis after ERCP

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
Лечение

Центры проведения

Пакистан · 1 центр
  • Shaikh Zayed hospital Lahore — Lahore

Идентификаторы

NCT: NCT07517627 · TERC/FB/INT/595/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗