Laparoscopic CholecystectomyNCT07130864
Early vs Late Laparoscopic Cholecystectomy After Common Bile Duct Stones Clearance Through Ercp.
A study testing Early cholecystectomy and Late cholecystectomy in people with Laparoscopic Cholecystectomy and Choledocholithiasis, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
There is controversy about timing of cholecystectomy after the common bile duct is cleared of stones. our study aims to compare the results of early vs late cholecystectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Cholecystectomy, Choledocholithiasis, ERCP
- What is being tested?
- Early cholecystectomy and Late cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 sitePakistan
- Study dates
- 23 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- .All patients undergoing laparoscopic cholecystectomy who had concomitant choledocholithiasis for which ercp is done.
Who cannot join
- .Non consenting indviduals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Khyber teaching hospital
Peshawar, Khyberpukhtunkhwa, 25000
Saeed Sarwar, MBBS, +923420973863, saeedkmc2020@gmail.com
About this study
Official title: Early Vs Late Laparoscopic Cholecystectomy After Ercp For Choledocholithiasis, A Randomised Control Trial.
There is controversy about timing of cholecystectomy after the common bile duct is cleared of stones. our study aims to compare the results of early vs late cholecystectomy.
- Being tested
- Early cholecystectomy, Late cholecystectomy
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early cholecystectomyProcedure or surgery
Early cholecystectomy is performed within 72 hours of ERCP.
Late cholecystectomyProcedure or surgery
Late cholecystectomy is performed after 72 hours of ERCP
| Study group | Role | What they receive |
|---|---|---|
| Early Group | Experimental | Early group consist of those patients whose cholecystectomy is performed within 72 hours of ERCP . Receives: Procedure: Early cholecystectomy |
| Late group | Experimental | Late group consist of those patients whose cholecystectomy is performed after 72 hours of ERCP. Receives: Procedure: Late cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulty level of cholecystectomy
the presence of diffuse pericholecystic scar adhesions, Calot's triangle with intense fibrosis, atrophic gallbladder, presence of a cholecysto-enteric or cholecyto-choledochal fistula, presence of necrotic changes, liver abscess or the presence of impacted stones and the help of a senior colleague will be considered a difficult cholecystectomy
Measured: From start of surgery till end, On day 1 of surgery
Secondary outcomes (2)
Bile duct injury
Bile duct injury that ocuurs intraoperatively or detected in postoperative period
Measured: From the day 1 of surgery till one month
Hospital stay
Hospital stay determined from day of surgery till discharge
Measured: from day 1 of surgery till discharge, upto 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start23 May 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Saeed Sarwar, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130864
- Sponsor's protocol ID
- 530/DME/KMC
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients confidentiality maybe breached
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Vs Late Laparoscopic Cholecystectomy After Ercp For Choledocholithiasis, A Randomised Control Trial.
- ClinicalTrials.gov ID
- NCT07130864
- Acronym / sponsor ID
- 530/DME/KMC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 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.
There is controversy about timing of cholecystectomy after the common bile duct is cleared of stones. our study aims to compare the results of early vs late cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Group | Experimental | Procedure: Early cholecystectomyEarly group consist of those patients whose cholecystectomy is performed within 72 hours of ERCP . |
| Late group | Experimental | Procedure: Late cholecystectomyLate group consist of those patients whose cholecystectomy is performed after 72 hours of ERCP. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- .All patients undergoing laparoscopic cholecystectomy who had concomitant choledocholithiasis for which ercp is done.
Key exclusion criteria (1 listed)
- .Non consenting indviduals
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 cholecystectomyEarly cholecystectomy is performed within 72 hours of ERCP. | Procedure or surgery | Early Group |
| Late cholecystectomyLate cholecystectomy is performed after 72 hours of ERCP | Procedure or surgery | Late group |
Primary outcome
Difficulty level of cholecystectomy
Time frame: From start of surgery till end, On day 1 of surgery
the presence of diffuse pericholecystic scar adhesions, Calot's triangle with intense fibrosis, atrophic gallbladder, presence of a cholecysto-enteric or cholecyto-choledochal fistula, presence of necrotic changes, liver abscess or the presence of impacted stones and the help of a senior colleague will be considered a difficult cholecystectomy
2 secondary outcomes
Bile duct injury
Time frame: From the day 1 of surgery till one month
Hospital stay
Time frame: from day 1 of surgery till discharge, upto 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No. Patients confidentiality maybe breached
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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.
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 cholecystectomy and Late cholecystectomy in people with Laparoscopic Cholecystectomy and Choledocholithiasis, run by Khyber Teaching Hospital 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saeed Sarwar, MBBS (+923420973863, saeedkmc2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulty level of cholecystectomy (time frame: From start of surgery till end, On day 1 of 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 19 Aug 2025.