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Completed

NCT Number: NCT07137546

Fundus-first Laparoscopic Cholecystectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liver and GIT hospital / Minia university

Minya, Minya Governorate, 61519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fundus-First Laparoscopic Cholecystectomy ( FFLC)

Procedure
  • 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

Classical Laparoscopic Cholecystectomy (CLC)

Procedure
  • 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

Primary outcomes

  1. Bile Duct Injury Rate

    Time frame: Intraoperative to 30 days postoperative

    Incidence of bile duct injury, confirmed by intraoperative cholangiography, direct visualization, or postoperative imaging.

Secondary outcomes

  1. Conversion to Open Surgery Rate

    Time frame: Intraoperative

    Rate of conversion from laparoscopic to open procedure due to dense adhesions, bleeding, unclear anatomy, or suspected BDI.

  2. Operative Time

    Time frame: Intraoperative

    Total time from skin incision to closure (minutes).

  3. Time to Achieve Critical View of Safety (CVS)

    Time frame: Intraoperative

    Time from incision to CVS achievement (minutes).

  4. CVS Achievement Rate

    Time frame: Intraoperative

    Proportion of cases where CVS was achieved.

  5. Estimated Blood Loss

    Time frame: Intraoperative

    Intraoperative blood loss (mL).

  6. Intraoperative Cholangiography Rate

    Time frame: Intraoperative

    Proportion requiring cholangiography for unclear anatomy or suspected stones.

  7. Gallbladder Perforation Rate

    Time frame: Intraoperative

    Incidence of intraoperative gallbladder perforation.

Other outcomes

  1. Intraoperative Complications Rate

    Time frame: Intraoperative

    Overall intraoperative complications (e.g., bleeding, perforation, injury).

  2. Postoperative Complications

    Time frame: Up to 30 days postoperative

    Rate of complications requiring treatment or intervention.

  3. Major Postoperative Complications

    Time frame: Up to 30 days postoperative

    Rate of complications requiring surgical intervention under anesthesia.

  4. Length of Hospital Stay

    Time frame: Postoperative

    Days from surgery to discharge .

  5. Readmission Rate Within 30 Days

    Time frame: 30 days postoperative

    Proportion readmitted for complications.

  6. Time to Return to Normal Activity

    Time frame: Up to 30 days postoperative

    Days to resume normal activities

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Fundus-first Laparoscopic Cholecystectomy in Difficult Gallbladder

Acronym: FFLC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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