Fundus-first Laparoscopic Cholecystectomy (FFLC)

Minia University

Status: Enrolling

Conditions: Cholecystitis; Pericholecystic Abscess; Acute Cholecystitis

Treatments: Procedure: Classical Laparoscopic Cholecystectomy (CLC); Procedure: Fundus-First Laparoscopic Cholecystectomy ( FFLC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07137546

1131/04/2024

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 2 patient groups

Fundus-First Laparoscopic Cholecystectomy ( FFLC)

Experimental group

Description:

Laparoscopic cholecystectomy starting dissection at the gallbladder fundus, progressing retrograde toward the cystic duct/artery. Critical View of Safety (CVS) confirmed before duct division.

Treatment:

Procedure: Fundus-First Laparoscopic Cholecystectomy ( FFLC)

Classical Laparoscopic Cholecystectomy (CLC)

Active Comparator group

Description:

The standard "critical view of safety" technique (anterior-posterior dissection of Calot's triangle first).

Treatment:

Procedure: Classical Laparoscopic Cholecystectomy (CLC)