Choledocholithiasis with CholecystitisNCT06599437
For Patients with Stones in Gallbladder and Bile Duct Stones At the Same Time, Surgical Removal of the Gallbladder with the Laparoscope is Done in the Same Admission Compared to Its Removal After 6 Weeks Following Successful Removel of the Stones from the Bile Ducts by the Side View Endoscope
A study testing laparoscopic cholecystectomy and Late laparoscopic cholecystectomy in people with Choledocholithiasis with Cholecystitis, run by Damanhour Medical National Institute at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if early laparoscopic cholecystectomy is safe and feasible when performed during the same admission for patients with concomitant gallbladder and common bile duct stones after clearance of CBD stones via ERCP in comparison to Late laparoscopic cholecystectomy 6 weeks after… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Choledocholithiasis with Cholecystitis
- What is being tested?
- laparoscopic cholecystectomy and Late laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 15 Aug 2024
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with concomitant gallbladder and common bile duct stone who underwent clearance of common bile duct stones by ERCP
Who cannot join
- Severe pancreatitis
- Suspicion of post-ERCP bleeding or perforation,
- Associated malignancy
- Those in whom ERCP failed to clear the CBD stones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Index Laparoscopic Cholecystectomy Following Clearance of Common Bile Duct Stones Via Endoscopic Retrograde Cholangiography
The goal of this clinical trial is to learn if early laparoscopic cholecystectomy is safe and feasible when performed during the same admission for patients with concomitant gallbladder and common bile duct stones after clearance of CBD stones via ERCP in comparison to Late laparoscopic cholecystectomy 6 weeks after ERCP. The main questions it aims to answer are: laparoscopic cholecystectomy
- Does index laparoscopic cholecystectomy associate with less recurrence of biliary complications?
- Is index laparoscopic cholecystectomy feasible and safe for the patients in terms of intraoperative difficulties, conversion to open, hospital stay, and postoperative complications than late laparoscopic cholecystectomy? the investigator will compare index laparoscopic cholecystectomy with late laparoscopic cholecystectomy 6 weeks after ERCP to see if index laparoscopic cholecystectomy is safe and feasible and associated with better outcomes.
Read more
Participants will:
Come to the outpatient clinic every week after intervention for follow-up for 3 months after surgery.
Read the detailed description
The study population of this randomized controlled trial study is those who underwent CBD stone clearance by ERCP. The included fifty patients were stratified randomly into two groups: early and delayed.
Randomization was done using computer-generated random number sequences in concealed envelopes with a block randomization design. Laparoscopic cholecystectomy is performed on the next day after successful clearance of stones from CBD while, the patient is still admitted, for the early group and postponed 4 to 6 weeks for the delayed group after the patient is discharged home.
Laparoscopic cholecystectomy was performed by the same surgical team for both groups.
- Conditions
- Choledocholithiasis with Cholecystitis
- Being tested
- laparoscopic cholecystectomy, Late laparoscopic cholecystectomy
- Keywords
- choledocholithiasis, ERCP, Early cholecystectomy
- 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
Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP.
Late laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct.
| Study group | Role | What they receive |
|---|---|---|
| Early same admission laparoscopic cholecystectomy ( group A) | Active comparator | Early laparoscopic cholecystectomy is performed on next day within 24 hours after common bile duct stone removal by ERCP. Receives: Procedure: laparoscopic cholecystectomy |
| Late laparoscopic cholecystectomy ( group B) | Active comparator | Late laparoscopic cholecystectomy is performed 6 weeks after common bile duct stones clearance Receives: Procedure: Late laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of biliary events
the occurence of acute cholecystitism biliary colics, common bile duct stonem pancreatitisand cholangitis after ERCP while waiting for laparoscopic cholecystectomy
Measured: up to 3 months after surgery
Secondary outcomes (9)
operative time
time from the first incision of skin to skin closure and completion of surgery
Measured: during surgery
pancreatitis
acute inflammation of the pancreas : abdominal pain, elevated lipase and amylase ( more than 3 folds) and/or findings specific for the pancreatitits on imaging.
Measured: 3 months after surgery
conversion to open surgery
termination of the laparoscopic procedure and perfome the surgery by the conventional open surgery
Measured: During surgery
Bleeding
Intraoperative or postoperative bleeding that requires blood transfusion
Measured: during surger and up to 3 weeks
the presence of intraoperative adhesions
Adhesions around the gallbladder and at the Calot\'s triangle
Measured: During surgery
Bile leak
the leak of bile through the drain or intraabdominally
Measured: up to 1 week after surgery
Wound infection
Any evidence of infection in the wounds : redness, pain or discharge of infected fluids from the wounds
Measured: up to 3 months after surgery
hospital stays
the sum the length of stay after ERCP and laparoscopic cholecystectomy including readmission for complication management
Measured: from admission to the end of post operative follow up at 3 months after surgery
post oprative pain
the degree pain described by the patients after surgery on the visual rating scale
Measured: after surgery and up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2021
- Primary completion1 Apr 2024
- Study completion15 Aug 2024
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.
- 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
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour Medical National Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wael Ahmed El-Dawy, Damanhour Medical National Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599437
- Sponsor's protocol ID
- HD000192
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- 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 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Index Laparoscopic Cholecystectomy Following Clearance of Common Bile Duct Stones Via Endoscopic Retrograde Cholangiography
- ClinicalTrials.gov ID
- NCT06599437
- Acronym / sponsor ID
- HD000192
- Conditions
- Choledocholithiasis with Cholecystitis
- Keywords
- choledocholithiasis, ERCP, Early cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Damanhour Medical National InstituteOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to learn if early laparoscopic cholecystectomy is safe and feasible when performed during the same admission for patients with concomitant gallbladder and common bile duct stones after clearance of CBD stones via ERCP in comparison to Late laparoscopic cholecystectomy 6 weeks after ERCP. The main questions it aims to answer are: laparoscopic cholecystectomy
- Does index laparoscopic cholecystectomy associate with less recurrence of biliary complications?
- Is index laparoscopic cholecystectomy feasible and safe for the patients in terms of intraoperative difficulties, conversion to open, hospital stay, and postoperative complications than late laparoscopic cholecystectomy? the investigator will compare index laparoscopic cholecystectomy with late laparoscopic cholecystectomy 6 weeks after ERCP to see if index laparoscopic cholecystectomy is safe and feasible and associated with better outcomes.
Participants will:
Come to the outpatient clinic every week after intervention for follow-up for 3 months after surgery.
Detailed description
The study population of this randomized controlled trial study is those who underwent CBD stone clearance by ERCP. The included fifty patients were stratified randomly into two groups: early and delayed.
Randomization was done using computer-generated random number sequences in concealed envelopes with a block randomization design. Laparoscopic cholecystectomy is performed on the next day after successful clearance of stones from CBD while, the patient is still admitted, for the early group and postponed 4 to 6 weeks for the delayed group after the patient is discharged home.
Laparoscopic cholecystectomy was performed by the same surgical team for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early same admission laparoscopic cholecystectomy ( group A) | Active comparator | Procedure: laparoscopic cholecystectomyEarly laparoscopic cholecystectomy is performed on next day within 24 hours after common bile duct stone removal by ERCP. |
| Late laparoscopic cholecystectomy ( group B) | Active comparator | Procedure: Late laparoscopic cholecystectomyLate laparoscopic cholecystectomy is performed 6 weeks after common bile duct stones clearance |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with concomitant gallbladder and common bile duct stone who underwent clearance of common bile duct stones by ERCP
Key exclusion criteria (4 listed)
- Severe pancreatitis
- Suspicion of post-ERCP bleeding or perforation,
- Associated malignancy
- Those in whom ERCP failed to clear the CBD stones
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 cholecystectomyEarly laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP. | Procedure or surgery | Early same admission laparoscopic cholecystectomy ( group A) |
| Late laparoscopic cholecystectomyLaparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct. | Procedure or surgery | Late laparoscopic cholecystectomy ( group B) |
Primary outcome
recurrence of biliary events
Time frame: up to 3 months after surgery
the occurence of acute cholecystitism biliary colics, common bile duct stonem pancreatitisand cholangitis after ERCP while waiting for laparoscopic cholecystectomy
9 secondary outcomes
operative time
Time frame: during surgery
pancreatitis
Time frame: 3 months after surgery
conversion to open surgery
Time frame: During surgery
Bleeding
Time frame: during surger and up to 3 weeks
the presence of intraoperative adhesions
Time frame: During surgery
Bile leak
Time frame: up to 1 week after surgery
Wound infection
Time frame: up to 3 months after surgery
hospital stays
Time frame: from admission to the end of post operative follow up at 3 months after surgery
post oprative pain
Time frame: after surgery and up to 3 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 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Late laparoscopic cholecystectomy in people with Choledocholithiasis with Cholecystitis, run by Damanhour Medical National Institute 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 4 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 Sep 2024. 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?
recurrence of biliary events (time frame: up to 3 months after 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 Sep 2024.