Fundus-first Laparoscopic Cholecystectomy

NCT ID: NCT07137546

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-01-01

Brief Summary

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.

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.

Conditions

Cholecystitis; Acute Cholecystitis; Pericholecystic Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fundus-First Laparoscopic Cholecystectomy ( FFLC)

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

Classical Laparoscopic Cholecystectomy (CLC)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Saleh Khairy Saleh MD

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saleh K Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Liver and GIT hospital / Minia university

Minya, Minya Governorate, Egypt

Countries

Egypt

Other Identifiers

1131/04/2024

Identifier Type: -

Identifier Source: org_study_id