Common Bile Duct ClosureNCT04264299
Comparative Study of Three Common Bile Duct Closure Techniques
A study testing T tube drainage, Primary closure and Antegrade stenting in people with Common Bile Duct Closure, run by South Valley University at 1 site in Egypt.
Trial summary
This study evaluates the efficacy and safety of three different methods of CBD repair after common bile duct exploration and provides more evidence for selecting the optimal duct closure after choledocholithotomy. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Bile Duct Closure
- What is being tested?
- T tube drainage, Primary closure and Antegrade stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 30 Apr 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CBD stones
- age from 20 to 80,
- CBD > 0.8 cm and < 2.5 cm,
- American Society of Anesthesiologists (ASA) grade I, II or III,
- agreement to randomization and complete the study requirement. Exclusion criteria
- acute suppurative cholangitis,
Show all 12Show fewer
- acute biliary pancreatitis,
- biliary malignancy,
- biliary malformation,
- distal CBD stenosis and or obstruction,
- trans-cystic stone extraction,
- explorations followed by choledochojejunostomy and choledochoduodenostomy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Three Common Bile Duct Closure Techniques After Choledocholithotomy: Safety and Efficacy
This study evaluates the efficacy and safety of three different methods of CBD repair after common bile duct exploration and provides more evidence for selecting the optimal duct closure after choledocholithotomy.
Read the detailed description
At present, the commonest available options for CBD closure include repair over T-tube drain, primary closure, and repair after antegrade biliary stenting. All three methods present specific technical performance features, require different postoperative management protocols, and are charged with specific morbidity related to the procedure and therefore should not be considered the same procedure in the context of CBDE.
Repair over T-tube is the traditional surgical technique. It has many advantages as post-operative distal CBD decompression, trans-tubal cholangiography, and availability of retained CBD stones extraction. However, it has several potential complications up to 10% of patients. The most frequent complications are bile leakage, tract infection, T-tube dislodgement, electrolyte and nutritional disturbances, cholangitis, or acute renal failure from dehydration due to inadequate water ingestion. It also causes discomfort and persistent pain to the patient along with increased hospital admission and thus the economic burden to the country. Primary closure of CBD has been described in the literature to overcome these adverse consequences of the T-tube. However, it has many potential complications as a potential bile leak and CBD stricture, which may occur due to papillary edema and insufficient bile duct expansion. There are conflicting results regarding significant differences in the morbidity and mortality between primary closure and T-tube drainage. There is no conclusive evidence displaying whether primary closure is better or worse than T-tube drainage after CBD exploration.
Using a biliary stent in primary closure is an effective method to decrease the two complications, which can reduce biliary pressure without bile loss. Although there are some available drainage options after CBDE, a consensus on the optimal drainage is yet to be reached.
- Conditions
- Common Bile Duct Closure
- Being tested
- T tube drainage, Primary closure, Antegrade stenting
- Keywords
- choledocholithiasis, T-tube, primary repair, biliary stenting
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T tube drainageProcedure or surgery
closure of common bile duct over T tube
Primary closureProcedure or surgery
Primary closure of common bile duct
Antegrade stentingProcedure or surgery
Closure of common bile duct over antegrade plastic biliary stent
| Study group | Role | What they receive |
|---|---|---|
| T tube drainage | Active comparator | Closure of common bile duct after choledocholithotomy over T tube Receives: Procedure: Primary closure; Procedure: Antegrade stenting |
| Primary closure | Experimental | Primary closure of the common bile duct after choledocholithotomy Receives: Procedure: T tube drainage; Procedure: Antegrade stenting |
| Antegrade stenting | Experimental | Closure of common bile duct over antegrade biliary plastic stent Receives: Procedure: T tube drainage; Procedure: Primary closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative bile leak
The discharge of fluid via intra-abdominal drain or intra-abdominal fluid with bilirubin concentration at least 3 times the serum bilirubin concentration measured at the same time on or after the 3rd postoperative day, or as the need for radiologic or surgical intervention because of biliary collections.
Measured: 3rd to 7th postoperative day
Post operative biliary stricture
The segmental shrunken of CBD diameter and proximal dilatation by MRCP.
Measured: 6 month
Recurrent biliary stones
Common bile duct stone after 6 months of the procedure
Measured: 6 month
Secondary outcomes (8)
Visual analogue score
the severity of postoperative pain. from 0 (no pain) to 10 (maximum pain)
Measured: 3 days
The number of patients need postoperative opioid
The patients need of postoperative opioid (pethidine Hcl 50 mg)
Measured: 3 days
Postoperative bilirubin level
the rate of decreased bilirubin postoperatively
Measured: 7 days
Hospital stays
the number of days in hospital from the day of operation to the day of discharge
Measured: 10 days
Drain-carried time
the number of days before drain removal
Measured: 20 days
Total cost of treatment
The cost of intervention and management of postoperative complications
Measured: Through study completion, average 6 month
Return to normal activity
the number of days required for the patient to return to normal activity
Measured: 30 days
Type of re-intervention
the number of intervention required for each patient totally
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct ClosureStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed Omar, South Valley University
- Investigators
- Mohammed A. Omar, Ass. Prof., Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264299
- Sponsor's protocol ID
- SVU 300
- Status last verified
- May 2021
- First submitted
- 7 Feb 2020
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Omar MA, Redwan AA, Alansary MN. Comparative study of three common bile duct closure techniques after choledocholithotomy: safety and efficacy. Langenbecks Arch Surg. 2022 Aug;407(5):1805-1815. doi: 10.1007/s00423-022-02597-3. Epub 2022 Jul 4.
PubMed 35786738
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Three Common Bile Duct Closure Techniques After Choledocholithotomy: Safety and Efficacy
- ClinicalTrials.gov ID
- NCT04264299
- Acronym / sponsor ID
- SVU 300
- Conditions
- Common Bile Duct Closure
- Keywords
- choledocholithiasis, T-tube, primary repair, biliary stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 11 Feb 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.
This study evaluates the efficacy and safety of three different methods of CBD repair after common bile duct exploration and provides more evidence for selecting the optimal duct closure after choledocholithotomy.
Detailed description
At present, the commonest available options for CBD closure include repair over T-tube drain, primary closure, and repair after antegrade biliary stenting. All three methods present specific technical performance features, require different postoperative management protocols, and are charged with specific morbidity related to the procedure and therefore should not be considered the same procedure in the context of CBDE.
Repair over T-tube is the traditional surgical technique. It has many advantages as post-operative distal CBD decompression, trans-tubal cholangiography, and availability of retained CBD stones extraction. However, it has several potential complications up to 10% of patients. The most frequent complications are bile leakage, tract infection, T-tube dislodgement, electrolyte and nutritional disturbances, cholangitis, or acute renal failure from dehydration due to inadequate water ingestion. It also causes discomfort and persistent pain to the patient along with increased hospital admission and thus the economic burden to the country. Primary closure of CBD has been described in the literature to overcome these adverse consequences of the T-tube. However, it has many potential complications as a potential bile leak and CBD stricture, which may occur due to papillary edema and insufficient bile duct expansion. There are conflicting results regarding significant differences in the morbidity and mortality between primary closure and T-tube drainage. There is no conclusive evidence displaying whether primary closure is better or worse than T-tube drainage after CBD exploration.
Using a biliary stent in primary closure is an effective method to decrease the two complications, which can reduce biliary pressure without bile loss. Although there are some available drainage options after CBDE, a consensus on the optimal drainage is yet to be reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T tube drainage | Active comparator | Procedure: Primary closure, Procedure: Antegrade stentingClosure of common bile duct after choledocholithotomy over T tube |
| Primary closure | Experimental | Procedure: T tube drainage, Procedure: Antegrade stentingPrimary closure of the common bile duct after choledocholithotomy |
| Antegrade stenting | Experimental | Procedure: T tube drainage, Procedure: Primary closureClosure of common bile duct over antegrade biliary plastic stent |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- CBD stones
- age from 20 to 80,
- CBD > 0.8 cm and < 2.5 cm,
- American Society of Anesthesiologists (ASA) grade I, II or III,
- agreement to randomization and complete the study requirement. Exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| T tube drainageclosure of common bile duct over T tube | Procedure or surgery | Antegrade stenting, Primary closure |
| Primary closurePrimary closure of common bile duct | Procedure or surgery | Antegrade stenting, T tube drainage |
| Antegrade stentingClosure of common bile duct over antegrade plastic biliary stent | Procedure or surgery | Primary closure, T tube drainage |
Primary outcome
Postoperative bile leak
Time frame: 3rd to 7th postoperative day
The discharge of fluid via intra-abdominal drain or intra-abdominal fluid with bilirubin concentration at least 3 times the serum bilirubin concentration measured at the same time on or after the 3rd postoperative day, or as the need for radiologic or surgical intervention because of biliary collections.
Post operative biliary stricture
Time frame: 6 month
The segmental shrunken of CBD diameter and proximal dilatation by MRCP.
Recurrent biliary stones
Time frame: 6 month
Common bile duct stone after 6 months of the procedure
8 secondary outcomes
Visual analogue score
Time frame: 3 days
The number of patients need postoperative opioid
Time frame: 3 days
Postoperative bilirubin level
Time frame: 7 days
Hospital stays
Time frame: 10 days
Drain-carried time
Time frame: 20 days
Total cost of treatment
Time frame: Through study completion, average 6 month
Return to normal activity
Time frame: 30 days
Type of re-intervention
Time frame: 6 month
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 11 May 2021.
- Derived from this study: PubMed 35786738Omar MA, Redwan AA, Alansary MN. Comparative study of three common bile duct closure techniques after choledocholithotomy: safety and efficacy. Langenbecks Arch Surg. 2022 Aug;407(5):1805-1815. doi: 10.1007/s00423-022-02597-3. Epub 2022 Jul 4.
- Individual participant dataSharing planned: No
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, Ass. Prof. principal investigator
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 T tube drainage, Primary closure and Antegrade stenting in people with Common Bile Duct Closure, 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 12 inclusion and 0 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 11 May 2021. 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?
Postoperative bile leak (time frame: 3rd to 7th postoperative day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04264299, which also lists 1 linked publication.
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 11 May 2021.