CholecystitisFFLCNCT07137546
Fundus-first Laparoscopic Cholecystectomy
A study testing Fundus-First Laparoscopic Cholecystectomy ( FFLC) and Classical Laparoscopic Cholecystectomy (CLC) in people with Cholecystitis and Acute Cholecystitis, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholecystitis, Acute Cholecystitis, Pericholecystic Abscess
- What is being tested?
- Fundus-First Laparoscopic Cholecystectomy ( FFLC) and Classical Laparoscopic Cholecystectomy (CLC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 17 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- Previous biliary or hepatic surgery
- Cirrhosis with portal hypertension
- Active coagulopathy
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Liver and GIT hospital / Minia university
Minya, Minya Governorate, 61519
About this study
Official title: 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.
Read the 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
- Being tested
- Fundus-First Laparoscopic Cholecystectomy ( FFLC), Classical Laparoscopic Cholecystectomy (CLC)
- Keywords
- Fundus-first laparoscopic cholecystectomy, Conventional laparoscopic cholecystectomy, Bile duct injury, Difficult gallbladder, Critical view of safety
- Medical subject headings
- Cholecystitis, Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundus-First Laparoscopic Cholecystectomy ( FFLC)Procedure or surgery
- 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 or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Fundus-First Laparoscopic Cholecystectomy ( FFLC) | Experimental | Laparoscopic cholecystectomy starting dissection at the gallbladder fundus, progressing retrograde toward the cystic duct/artery. Critical View of Safety (CVS) confirmed before duct division. Receives: Procedure: Fundus-First Laparoscopic Cholecystectomy ( FFLC) |
| Classical Laparoscopic Cholecystectomy (CLC) | Active comparator | The standard "critical view of safety" technique (anterior-posterior dissection of Calot's triangle first). Receives: Procedure: Classical Laparoscopic Cholecystectomy (CLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bile Duct Injury Rate
Incidence of bile duct injury, confirmed by intraoperative cholangiography, direct visualization, or postoperative imaging.
Measured: Intraoperative to 30 days postoperative
Secondary outcomes (7)
Conversion to Open Surgery Rate
Rate of conversion from laparoscopic to open procedure due to dense adhesions, bleeding, unclear anatomy, or suspected BDI.
Measured: Intraoperative
Operative Time
Total time from skin incision to closure (minutes).
Measured: Intraoperative
Time to Achieve Critical View of Safety (CVS)
Time from incision to CVS achievement (minutes).
Measured: Intraoperative
CVS Achievement Rate
Proportion of cases where CVS was achieved.
Measured: Intraoperative
Estimated Blood Loss
Intraoperative blood loss (mL).
Measured: Intraoperative
Intraoperative Cholangiography Rate
Proportion requiring cholangiography for unclear anatomy or suspected stones.
Measured: Intraoperative
Gallbladder Perforation Rate
Incidence of intraoperative gallbladder perforation.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 May 2024
- Primary completion1 Feb 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Khairy Saleh MD, Minia University
- Investigators
- Saleh K Saleh, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137546
- Sponsor's protocol ID
- 1131/04/2024
- Acronym
- FFLC
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fundus-first Laparoscopic Cholecystectomy in Difficult Gallbladder
- ClinicalTrials.gov ID
- NCT07137546
- Acronym / sponsor ID
- FFLC / 1131/04/2024
- Conditions
- Cholecystitis, Acute Cholecystitis, Pericholecystic Abscess
- Keywords
- Fundus-first laparoscopic cholecystectomy, Conventional laparoscopic cholecystectomy, Bile duct injury, Difficult gallbladder, Critical view of safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fundus-First Laparoscopic Cholecystectomy ( FFLC) | Experimental | Procedure: 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. |
| Classical Laparoscopic Cholecystectomy (CLC) | Active comparator | Procedure: Classical Laparoscopic Cholecystectomy (CLC)The standard "critical view of safety" technique (anterior-posterior dissection of Calot's triangle first). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Suspected gallbladder malignancy
- Choledocholithiasis requiring endoscopic intervention
- Mirizzi syndrome Grade III-IV
- Gallbladder perforation with generalized peritonitis
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Fundus-First Laparoscopic Cholecystectomy ( FFLC) |
| 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 | Procedure or surgery | Classical Laparoscopic Cholecystectomy (CLC) |
Primary outcome
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.
7 secondary outcomes
Conversion to Open Surgery Rate
Time frame: Intraoperative
Operative Time
Time frame: Intraoperative
Time to Achieve Critical View of Safety (CVS)
Time frame: Intraoperative
CVS Achievement Rate
Time frame: Intraoperative
Estimated Blood Loss
Time frame: Intraoperative
Intraoperative Cholangiography Rate
Time frame: Intraoperative
Gallbladder Perforation Rate
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saleh K Saleh, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fundus-First Laparoscopic Cholecystectomy ( FFLC) and Classical Laparoscopic Cholecystectomy (CLC) in people with Cholecystitis and Acute Cholecystitis, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bile Duct Injury Rate (time frame: Intraoperative to 30 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.