Choledocholithiasis With CholecystitisNCT04475796
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
A study testing Laparoscopic cholecystectomy in people with Choledocholithiasis With Cholecystitis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Choledocholithiasis With Cholecystitis
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 May 2020
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who underwent laparoscopic cholecystectomy after clearance of CBDs by ERCP
Who cannot join
- advanced liver cirrhosis, pancreatitis, acute cholangitis, suspected malignancy, severe malnutrition, and pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516
About this study
The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones.
Read the detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile duct stones (CBDs) and gallbladder stones. There has been a debate about the appropriate timing of laparoscopic cholecystectomy after ERCP. The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new parameters like Nassar scale.
- Conditions
- Choledocholithiasis With Cholecystitis
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- Choledocholithiasis, Early, Delayed, Laparoscopic cholecystectomy, ERCP, Nassar scale
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy performed after ERCP
| Study group | Role | What they receive |
|---|---|---|
| Early group | Active comparator | Not described Receives: Procedure: Laparoscopic cholecystectomy |
| Delayed group | Active comparator | Not described Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
the time to perform laparoscopic cholecystectomy from the time of incision to the last suture
Measured: one day
Secondary outcomes (1)
intraoperative difficulty and complications
the difficulties that face the surgeon during the surgery and the early complications that result
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Feb 2019
- Primary completion1 Feb 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choledocholithiasis With CholecystitisStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aouf, Kafrelsheikh University
- Investigators
- Ahmed Aouf, Dr., Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475796
- Sponsor's protocol ID
- 124569124569
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
- ClinicalTrials.gov ID
- NCT04475796
- Acronym / sponsor ID
- 124569124569
- Conditions
- Choledocholithiasis With Cholecystitis
- Keywords
- Choledocholithiasis, Early, Delayed, Laparoscopic cholecystectomy, ERCP, Nassar scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 17 Jul 2020 (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.
The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones.
Detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile duct stones (CBDs) and gallbladder stones. There has been a debate about the appropriate timing of laparoscopic cholecystectomy after ERCP. The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new parameters like Nassar scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early group | Active comparator | Procedure: Laparoscopic cholecystectomy |
| Delayed group | Active comparator | Procedure: Laparoscopic cholecystectomy |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who underwent laparoscopic cholecystectomy after clearance of CBDs by ERCP
Key exclusion criteria (1 listed)
- advanced liver cirrhosis, pancreatitis, acute cholangitis, suspected malignancy, severe malnutrition, and pregnancy.
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 |
|---|---|---|
| Laparoscopic cholecystectomyLaparoscopic cholecystectomy performed after ERCP | Procedure or surgery | Delayed group, Early group |
Primary outcome
operative time
Time frame: one day
the time to perform laparoscopic cholecystectomy from the time of incision to the last suture
1 secondary outcome
intraoperative difficulty and complications
Time frame: one day
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 17 Jul 2020.
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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.
Ahmed Aouf, Dr. principal investigator
Kafrelsheikh 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 Laparoscopic cholecystectomy in people with Choledocholithiasis With Cholecystitis, run by Kafrelsheikh 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 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: finished, as of the sponsor's last update on 17 Jul 2020. 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?
operative time (time frame: one day). 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 17 Jul 2020.