Cholelithiasis Associated With Common Bile Duct StonesED-LCNCT07517627
Optimal Timings of Laparoscopic Cholecystectomy After ERCP in Patients With Gallstones Along With CBD Stones
A study testing Early laparoscopic cholecystectomy and Delayed Laparoscopic cholecystectomy in people with Cholelithiasis Associated With Common Bile Duct Stones, run by Rija Zainab at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the mean operative time and outcomes of early versus delayed laparoscopic cholecystectomy after ERCP in patients with cholelithiasis and choledocholithiasis. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Cholelithiasis Associated With Common Bile Duct Stones
- What is being tested?
- Early laparoscopic cholecystectomy and Delayed Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2025to 1 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with cholelithiasis with choledocholithiasis based on clinical and radiological findings (right subcostal pain, presence of gallstones, and dilated common bile duct on ultrasound and MRCP)
- Age 14 to 70 years
- Both males and females
- Duration of symptoms less than 3 days
- Presence of common bile duct stone with successful clearance on ERCP
Who cannot join
- Features suggestive of malignancy on imaging
- Patients who develop severe pancreatitis after ERCP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Early Versus Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography (ERCP) in Patients of Cholelithiasis With Choledocholithiasis
This randomized controlled trial aims to compare the mean operative time and outcomes of early versus delayed laparoscopic cholecystectomy after ERCP in patients with cholelithiasis and choledocholithiasis. Patients will be randomized into two groups: early cholecystectomy (within 72 hours of ERCP) and delayed cholecystectomy (≥1 month after ERCP). Outcomes include operative time, intra-operative blood loss, hospital stay, and conversion to open cholecystectomy
Read the detailed description
Gallstones are among the most common surgical problems worldwide, and up to 20% of patients with gallstones also present with stones in the common bile duct. Standard care involves clearance of bile duct stones, typically by Endoscopic Retrograde Cholangiopancreaticography (ERCP), followed by removal of the gallbladder by laparoscopic cholecystectomy (LC).
The timing of cholecystectomy after ERCP remains debated. Early LC (within 72 hours) has been associated with fewer recurrent biliary events, reduced hospital stay, and potentially easier operative conditions. However, delayed LC (after one month) continues to be widely practiced due to institutional factors and scheduling constraints.
This randomized controlled trial at Sheikh Zayed Hospital, Lahore, is designed to evaluate whether early LC after ERCP offers measurable advantages compared with delayed LC. Patients with confirmed cholelithiasis and choledocholithiasis will be randomized into two groups: early surgery and delayed surgery. The trial will provide local evidence to guide surgical practice, focusing on operative efficiency and patient recovery.
By clarifying the optimal timing of LC after ERCP in our patient population, the study aims to support evidence-based surgical decision-making, improve outcomes, and potentially reduce healthcare costs.
- Being tested
- Early laparoscopic cholecystectomy, Delayed Laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early laparoscopic cholecystectomyProcedure or surgery
Laparoscopic removal of gall bladder within 72hours of laparoscopic cholecystectomy
Delayed Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic removal of gall bladder 4 weeks or more after successful ERCP
| Study group | Role | What they receive |
|---|---|---|
| Early laparoscopic cholecystectomy | Experimental | Patients will undergo laparoscopic cholecystectomy within 72hours followed by successful ERCP Receives: Procedure: Early laparoscopic cholecystectomy |
| Delayed Laparoscopic cholecystectomy | Active comparator | Patients will undergo laparoscopic cholecystectomy 4 weeks or more after successful ERCP Receives: Procedure: Delayed Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Operative time
Duration of surgery measured from the first incision to closure of the last incision.
Measured: During surgery
Secondary outcomes (3)
Length of Hospital Stay
Total number of days from hospital admission to discharge.
Measured: From admission to discharge (up to 30 days)
Intraoperative Blood Loss
Blood loss measured in milliliters from suction apparatus during surgery.
Measured: During Surgery
Conversion to Open Cholecystectomy
Number of patients requiring conversion from laparoscopic to open surgery
Measured: During Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start5 May 2025
- Primary completion6 Oct 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholelithiasis Associated With Common Bile Duct StonesStudies 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
- Model description
- Parallel Assignment (Two arms, Early vs Delayed Laparoscopic cholecystectomy)
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rija Zainab
- Sponsor type
- University, hospital or other
- Collaborators
- Shaikh Zayed Hospital, Lahore
- Responsible party
- Sponsor-investigator, Rija Zainab, Shaikh Zayed Hospital, Lahore
- Investigators
- Dr. Rija Zainab, MS General surgery, Principal investigator, Shaikh Zayed Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517627
- Sponsor's protocol ID
- TERC/FB/INT/595/2024
- Acronym
- ED-LC
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because there is no plan to make individual participant-level data available to other researchers. Only aggregate study results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Early Versus Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography (ERCP) in Patients of Cholelithiasis With Choledocholithiasis
- ClinicalTrials.gov ID
- NCT07517627
- Acronym / sponsor ID
- ED-LC / TERC/FB/INT/595/2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rija ZainabUniversity, hospital or other
- Collaborators
- Shaikh Zayed Hospital, Lahore
- Study start
- 5 May 2025 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 8 Apr 2026 (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.
This randomized controlled trial aims to compare the mean operative time and outcomes of early versus delayed laparoscopic cholecystectomy after ERCP in patients with cholelithiasis and choledocholithiasis. Patients will be randomized into two groups: early cholecystectomy (within 72 hours of ERCP) and delayed cholecystectomy (≥1 month after ERCP). Outcomes include operative time, intra-operative blood loss, hospital stay, and conversion to open cholecystectomy
Detailed description
Gallstones are among the most common surgical problems worldwide, and up to 20% of patients with gallstones also present with stones in the common bile duct. Standard care involves clearance of bile duct stones, typically by Endoscopic Retrograde Cholangiopancreaticography (ERCP), followed by removal of the gallbladder by laparoscopic cholecystectomy (LC).
The timing of cholecystectomy after ERCP remains debated. Early LC (within 72 hours) has been associated with fewer recurrent biliary events, reduced hospital stay, and potentially easier operative conditions. However, delayed LC (after one month) continues to be widely practiced due to institutional factors and scheduling constraints.
This randomized controlled trial at Sheikh Zayed Hospital, Lahore, is designed to evaluate whether early LC after ERCP offers measurable advantages compared with delayed LC. Patients with confirmed cholelithiasis and choledocholithiasis will be randomized into two groups: early surgery and delayed surgery. The trial will provide local evidence to guide surgical practice, focusing on operative efficiency and patient recovery.
By clarifying the optimal timing of LC after ERCP in our patient population, the study aims to support evidence-based surgical decision-making, improve outcomes, and potentially reduce healthcare costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment (Two arms, Early vs Delayed Laparoscopic cholecystectomy)
| Arm | Type | Receives |
|---|---|---|
| Early laparoscopic cholecystectomy | Experimental | Procedure: Early laparoscopic cholecystectomyPatients will undergo laparoscopic cholecystectomy within 72hours followed by successful ERCP |
| Delayed Laparoscopic cholecystectomy | Active comparator | Procedure: Delayed Laparoscopic cholecystectomyPatients will undergo laparoscopic cholecystectomy 4 weeks or more after successful ERCP |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with cholelithiasis with choledocholithiasis based on clinical and radiological findings (right subcostal pain, presence of gallstones, and dilated common bile duct on ultrasound and MRCP)
- Age 14 to 70 years
- Both males and females
- Duration of symptoms less than 3 days
- Presence of common bile duct stone with successful clearance on ERCP
Key exclusion criteria (2 listed)
- Features suggestive of malignancy on imaging
- Patients who develop severe pancreatitis after ERCP
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 |
|---|---|---|
| Early laparoscopic cholecystectomyLaparoscopic removal of gall bladder within 72hours of laparoscopic cholecystectomy | Procedure or surgery | Early laparoscopic cholecystectomy |
| Delayed Laparoscopic cholecystectomyLaparoscopic removal of gall bladder 4 weeks or more after successful ERCP | Procedure or surgery | Delayed Laparoscopic cholecystectomy |
Primary outcome
Mean Operative time
Time frame: During surgery
Duration of surgery measured from the first incision to closure of the last incision.
3 secondary outcomes
Length of Hospital Stay
Time frame: From admission to discharge (up to 30 days)
Intraoperative Blood Loss
Time frame: During Surgery
Conversion to Open Cholecystectomy
Time frame: During Surgery
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 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because there is no plan to make individual participant-level data available to other researchers. Only aggregate study results will be reported.
Related trials for Cholelithiasis Associated With Common Bile Duct Stones
RecruitingObservational study
Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis
Cholelithiasis Associated With Common Bile Duct Stones
Recruiting
Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
Cholelithiasis Associated With Common Bile Duct Stones
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.
Dr. Rija Zainab, MS General surgery principal investigator
Shaikh Zayed Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early laparoscopic cholecystectomy and Delayed Laparoscopic cholecystectomy in people with Cholelithiasis Associated With Common Bile Duct Stones, run by Rija Zainab at 1 site in Pakistan.
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 5 inclusion and 2 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 7 Oct 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 Pakistan. 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?
Mean Operative time (time frame: During surgery). 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 7 Oct 2026.