Fundus-first Laparoscopic Cholecystectomy in Difficult Gallbladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Bile Duct Injury Rate
研究概览
简要总结
Bile duct injury (BDI) remains the most feared complication of laparoscopic cholecystectomy, particularly in difficult gallbladder cases. The fundus-first technique has emerged as a potentially safer alternative to classical laparoscopic cholecystectomy for challenging cases. This single-center, prospective, randomized controlled trial compared the efficacy and safety of fundus-first laparoscopic cholecystectomy (FF-LC) versus classical laparoscopic cholecystectomy (C-LC) in 174 patients with difficult gallbladder characteristics. The primary outcome was bile duct injury rate. Secondary outcomes included conversion to open surgery, operative parameters, and postoperative complications.
详细描述
Bile duct injury (BDI) rates remain 0.3-1.5% in difficult gallbladders. FFLC avoids early dissection near critical structures, potentially lowering BDI risk.
This randomized controlled trial aims to compare the safety and efficacy of fundus-first (FF) versus classical (Calot-first) laparoscopic cholecystectomy techniques in patients with difficult gallbladders. The study will evaluate perioperative outcomes, conversion rates, complications, and operative time between the two surgical approaches. Based on recent evidence suggesting an improved safety profile with the fundus-first technique, we hypothesize that the FF approach will demonstrate reduced bile duct injury rates and improved surgical outcomes in difficult cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Surgeons are not blinded due to the intervention's nature; data collectors, assessors, and analysts are blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Symptomatic cholelithiasis or cholecystitis requiring laparoscopic cholecystectomy (elective or emergency)
- •Difficult gallbladder characteristics: Acute cholecystitis (Tokyo Guidelines 2018 Grade II/III), wall thickness >4 mm on US, pericholecystic fluid, impacted stone in Hartmann's pouch/cystic duct, previous upper abdominal surgery, BMI >30 kg/m², ≥3 previous cholecystitis episodes, contracted gallbladder, Mirizzi syndrome Type I/II, empyema, severe pericholecystic adhesions on imaging, suspected anatomical variations
- •The American Society of Anesthesiologists (ASA) physical status I-III
- •Suitable for laparoscopic approach
- •Informed consent
排除标准
- •Suspected gallbladder malignancy
- •Choledocholithiasis requiring endoscopic intervention
- •Mirizzi syndrome Grade III-IV
- •Gallbladder perforation with generalized peritonitis
- •Pregnancy or lactation
- •Contraindications to laparoscopy (severe cardiopulmonary disease, coagulopathy)
- •Previous biliary or hepatic surgery
- •Cirrhosis with portal hypertension
- •Active coagulopathy
- •Patient refusal
研究组 & 干预措施
Fundus-First Laparoscopic Cholecystectomy ( FFLC)
Laparoscopic cholecystectomy starting dissection at the gallbladder fundus, progressing retrograde toward the cystic duct/artery. Critical View of Safety (CVS) confirmed before duct division.
干预措施: Fundus-First Laparoscopic Cholecystectomy ( FFLC) (Procedure)
Classical Laparoscopic Cholecystectomy (CLC)
The standard "critical view of safety" technique (anterior-posterior dissection of Calot's triangle first).
干预措施: Classical Laparoscopic Cholecystectomy (CLC) (Procedure)
结局指标
主要结局
Bile Duct Injury Rate
时间窗: Intraoperative to 30 days postoperative
Incidence of bile duct injury, confirmed by intraoperative cholangiography, direct visualization, or postoperative imaging.
次要结局
- Estimated Blood Loss(Intraoperative)
- CVS Achievement Rate(Intraoperative)
- Intraoperative Cholangiography Rate(Intraoperative)
- Gallbladder Perforation Rate(Intraoperative)
- Conversion to Open Surgery Rate(Intraoperative)
- Operative Time(Intraoperative)
- Time to Achieve Critical View of Safety (CVS)(Intraoperative)
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University