Fundus-first Laparoscopic Cholecystectomy (FFLC)

Fundus-first Laparoscopic Cholecystectomy in Difficult Gallbladder

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.

Study Overview

• Status: Completed
• Conditions: Cholecystitis; Acute Cholecystitis; Pericholecystic Abscess
• Intervention / Treatment: Procedure: Fundus-First Laparoscopic Cholecystectomy ( FFLC); Procedure: Classical Laparoscopic Cholecystectomy (CLC)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya Governorate
    • Minya, Minya Governorate, Egypt, 61519
      • Liver and GIT hospital / Minia university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Fundus-First Laparoscopic Cholecystectomy ( FFLC); Standard 4-port laparoscopic setup; Carbon dioxide (CO₂) pneumoperitoneum (12-15 mmHg); Dissection begins at gallbladder fundus; Peritoneum incised from infundibulum to fundus along liver bed; Gallbladder dissected from fundus toward infundibulum; Cystic artery and duct identified and divided last; Critical view of safety achieved before vessel division
Active Comparator: Classical Laparoscopic Cholecystectomy (CLC); The standard "critical view of safety" technique (anterior-posterior dissection of Calot's triangle first).	Procedure: Classical Laparoscopic Cholecystectomy (CLC); Standard 4-port laparoscopic setup; Carbon dioxide (CO₂) pneumoperitoneum (12-15 mmHg); Dissection begins at Calot's triangle; Critical view of safety achieved first; Cystic artery and duct divided before gallbladder bed dissection; Gallbladder dissected from liver bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bile Duct Injury Rate	Incidence of bile duct injury, confirmed by intraoperative cholangiography, direct visualization, or postoperative imaging.	Intraoperative to 30 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion to Open Surgery Rate	Rate of conversion from laparoscopic to open procedure due to dense adhesions, bleeding, unclear anatomy, or suspected BDI.	Intraoperative
Operative Time	Total time from skin incision to closure (minutes).	Intraoperative
Time to Achieve Critical View of Safety (CVS)	Time from incision to CVS achievement (minutes).	Intraoperative
CVS Achievement Rate	Proportion of cases where CVS was achieved.	Intraoperative
Estimated Blood Loss	Intraoperative blood loss (mL).	Intraoperative
Intraoperative Cholangiography Rate	Proportion requiring cholangiography for unclear anatomy or suspected stones.	Intraoperative
Gallbladder Perforation Rate	Incidence of intraoperative gallbladder perforation.	Intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Complications Rate	Overall intraoperative complications (e.g., bleeding, perforation, injury).	Intraoperative
Postoperative Complications	Rate of complications requiring treatment or intervention.	Up to 30 days postoperative
Major Postoperative Complications	Rate of complications requiring surgical intervention under anesthesia.	Up to 30 days postoperative
Length of Hospital Stay	Days from surgery to discharge .	Postoperative
Readmission Rate Within 30 Days	Proportion readmitted for complications.	30 days postoperative
Time to Return to Normal Activity	Days to resume normal activities	Up to 30 days postoperative

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Saleh K Saleh, MD, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): February 1, 2026
• Study Completion (Actual): February 17, 2026

Study Registration Dates

• First Submitted: August 14, 2025
• First Submitted That Met QC Criteria: August 15, 2025
• First Posted (Actual): August 22, 2025

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Bile duct injury; Conventional laparoscopic cholecystectomy; Fundus-first laparoscopic cholecystectomy; Difficult gallbladder; Critical view of safety
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: 1131/04/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No