Common Bile Duct CalculiNCT05901363
ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy
A study testing Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy and aparoscopic common bile duct exploration and laparoscopic cholecystectomy in people with Common Bile Duct Calculi, run by South Valley University at 1 site in Egypt.
Trial summary
Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Common Bile Duct Calculi
- What is being tested?
- Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy and aparoscopic common bile duct exploration and laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 30 Oct 2022
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with cholecystocholedocholithiasis
- American Society of Anesthesiologists (ASA) scores of I-III
- Age 20-70 years.
Who cannot join
- cholangitis,
- acute biliary pancreatitis,
- suspected Mirizzi syndrome,
- suspected hepatobiliary malignancy,
- perforated gallbladder,
- biliary peritonitis,
Show all 11Show fewer
- intrahepatic stones,
- pregnancy,
- previous cholecystectomy,
- altered anatomy such as Billroth II reconstruction or any form of Roux-en-Y reconstruction that interfere with the endoscopic approach,
- Contraindications to laparoscopic surgery as severe liver cirrhosis or upper abdominal surgery were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy for Cholecystocholedocholithiasis - The Same Operator: A Multicenter Randomized Controlled Trial
Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.
Read the detailed description
Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.
Single-session treatment of gallbladder and CBD stones is safe, efficient, shortens hospital stay, and is less expensive than staged procedures.
Although there is some evidence suggesting that LCBDE may be associated with a lower rate of retained stones compared with ERCP, previous studies comparing LCBDE with ERCP and stone extraction have collectively failed to demonstrate the superiority of one approach over the other.
- Conditions
- Common Bile Duct Calculi
- Being tested
- Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy, aparoscopic common bile duct exploration and laparoscopic cholecystectomy
- Keywords
- Endoscopic retrograde cholangiopancreatography, laparoscopic common bile duct exploration, Laparoscopic cholecystectomy, single operator, cholecystocholedocholithiasis
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomyProcedure or surgery
Also called ERCP plus LC
laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones
aparoscopic common bile duct exploration and laparoscopic cholecystectomyProcedure or surgery
Also called LCBDE plus LC
laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy | Experimental | endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy Receives: Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy |
| laparoscopic common bile duct exploration and laparoscopic cholecystectomy | Active comparator | Not described Receives: Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
successful laparoscopic cholecystectomy and successful common bile duct stone extraction
Measured: 2 years
Secondary outcomes (7)
operative time
the overall time of the procedure
Measured: from 1 to 5 hours
morbidity
any intraoperative or postoperative adverse event
Measured: 3 years
mortality
death of patient
Measured: 3 years
Hospital stay
the length of hospital stay from the day of admission to the day of discharge
Measured: 30 days
the number of hospital readmission
Measured: 3 years
the number of postoperative intervention
Measured: 3 years
The total cost of treatment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Feb 2019
- Primary completion30 Oct 2021
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct CalculiStudies 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, Investigator
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed Omar, MD, South Valley University
- Investigators
- Mohammed A Omar, Principal investigator, General Surgery Department, Faculty of Medicine, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901363
- Sponsor's protocol ID
- SVU/MED/SUR011/4/23/4/613
- Status last verified
- Jun 2023
- First submitted
- 3 Jun 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy for Cholecystocholedocholithiasis - The Same Operator: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05901363
- Acronym / sponsor ID
- SVU/MED/SUR011/4/23/4/613
- Conditions
- Common Bile Duct Calculi
- Keywords
- Endoscopic retrograde cholangiopancreatography, laparoscopic common bile duct exploration, Laparoscopic cholecystectomy, single operator, cholecystocholedocholithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 13 Jun 2023 (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.
Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.
Detailed description
Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.
Single-session treatment of gallbladder and CBD stones is safe, efficient, shortens hospital stay, and is less expensive than staged procedures.
Although there is some evidence suggesting that LCBDE may be associated with a lower rate of retained stones compared with ERCP, previous studies comparing LCBDE with ERCP and stone extraction have collectively failed to demonstrate the superiority of one approach over the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy | Experimental | Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomyendoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy |
| laparoscopic common bile duct exploration and laparoscopic cholecystectomy | Active comparator | Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with cholecystocholedocholithiasis
- American Society of Anesthesiologists (ASA) scores of I-III
- Age 20-70 years.
Key exclusion criteria (11 listed)
- cholangitis,
- acute biliary pancreatitis,
- suspected Mirizzi syndrome,
- suspected hepatobiliary malignancy,
- perforated gallbladder,
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 |
|---|---|---|
| Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomyAlso: ERCP plus LClaparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones | Procedure or surgery | Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy |
| aparoscopic common bile duct exploration and laparoscopic cholecystectomyAlso: LCBDE plus LClaparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones | Procedure or surgery | laparoscopic common bile duct exploration and laparoscopic cholecystectomy |
Primary outcome
success rate
Time frame: 2 years
successful laparoscopic cholecystectomy and successful common bile duct stone extraction
7 secondary outcomes
operative time
Time frame: from 1 to 5 hours
morbidity
Time frame: 3 years
mortality
Time frame: 3 years
Hospital stay
Time frame: 30 days
the number of hospital readmission
Time frame: 3 years
the number of postoperative intervention
Time frame: 3 years
The total cost of treatment
Time frame: 30 days
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 13 Jun 2023.
- Individual participant dataSharing planned: Yes. After publication
Related trials for Common Bile Duct Calculi
Recruiting
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Cholecystectomy, Laparoscopic, Choledocholithiasis
Recruiting
Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
Choledocholithiasis, Common Bile Duct Stones
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Cholecystolithiasis, Common Bile Duct Gall Stones
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
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.
Mohammed A Omar principal investigator
General Surgery Department, Faculty of Medicine, South Valley 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 Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy and aparoscopic common bile duct exploration and laparoscopic cholecystectomy in people with Common Bile Duct Calculi, run by South Valley 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 3 inclusion and 11 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 13 Jun 2023. 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?
success rate (time frame: 2 years). 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 13 Jun 2023.