Common Bile Duct InjuryNCT05436626
Post-cholecystectomy Major Bile Duct Injury
A study testing Delayed reconstruction in people with Common Bile Duct Injury, run by South Valley University.
Trial summary
Bile duct injury (BDI) is one of the devastating recognized complications of cholecystectomy which does not respect the seniority or experience of the surgeon. It has a disastrous impact on long-term survival, health-related quality of life, and healthcare costs as well as high rates of litigation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Common Bile Duct Injury
- What is being tested?
- Delayed reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2014to 31 Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with BDI within 6 weeks after open or laparoscopic cholecystectomy,
- E1 to E4 BDI,
- Failed stenting with endoscopic retrograde cholangiopancreatography (ERCP),
- American Society of Anesthesiologists (ASA) score I-III,
- Agreement to complete the study
Who cannot join
- Advanced liver cirrhosis.
- Benign or malignant bile duct stricture.
- concomitant vascular and visceral injury
About this study
Official title: Post-cholecystectomy Major Bile Duct Injury: Ideal Time to Repair Based on a Multicenter Study With Promising Results.
Bile duct injury (BDI) is one of the devastating recognized complications of cholecystectomy which does not respect the seniority or experience of the surgeon. It has a disastrous impact on long-term survival, health-related quality of life, and healthcare costs as well as high rates of litigation. The incidence of BDI increased with the introduction of laparoscopic cholecystectomy (LC) with an incidence of around 0.3-1.5%.
The initial aim of BDI is to manage abdominal and biliary sepsis and to transform an acute BDI into a controlled external biliary fistula.
Read more
The surgical treatment of postcholecystectomy BDI success depends on many factors as the severity of the injury, the centers and surgeon's experiences, the patient's condition, and the reconstruction time. The optimal time for the reconstruction and the patient's condition remains an active topic of interest and debate. Many papers discussed their impact on the short and long-term outcomes with different conflicting results from different institutions.
Based on the previous data and the absence of guidelines that recommend the timing of BDI reconstruction, the decision for the timing of reconstruction should be based on the predicted success of the operation, costs, and patient quality of life. If comparable morbidity and mortality outcomes can be obtained, patient quality of life and effective use of healthcare resources should be taken into consideration. We hypothesized that inadequate sepsis control and BDI reconstruction can be done safely at any time of presentation.
Our study aimed to present our experience in the management of major post-cholecystectomy BDI with HJ and analyze the impact of both the reconstruction time and the control of sepsis on the BDI reconstruction success rate. By analyzing the results of these three treatment strategies, we can better understand the factors that affect reconstruction success, costs, and health-related quality of life associated with BDI and subsequent repair.
Read the detailed description
Bile duct injury (BDI) is one of the devastating recognized complications of cholecystectomy which does not respect the seniority or experience of the surgeon. It has a disastrous impact on long-term survival, health-related quality of life, and healthcare costs as well as high rates of litigation. Most of these patients are young females, between the ages of 30 and 50 years, with a long life expectancy, and in their most productive years. The incidence of BDI increased with the introduction of laparoscopic cholecystectomy (LC) with an incidence of around 0.3-1.5%; additionally, it results in complete transection. In Egypt, LC is developing rapidly in the primary hospitals that have bad medical conditions and the practicing surgeons have now still beyond the initial learning curve associated with this technique. As a result, the incidence of BDI increased, furthermore the majority were major and complex injuries. Based on the worldwide cholecystectomy frequency, even this low rate of BDI presents a significant potential healthcare burden. Due to this, it is critical that these patients have prompt recognition of their problem and reliable treatment with a long-term success rate. The initial aim of BDI is to manage abdominal and biliary sepsis and to transform an acute BDI into a controlled external biliary fistula. Following this, the severity of the damage should be evaluated. Whereas minor injuries are usually treated with endoscopic or percutaneous intervention, major injuries represent a major challenge even for hepatobiliary surgeons (HBS), and reconstructive surgery by hepaticojejunostomy (HJ) is usually indicated. Successful surgical reconstruction of Type E injuries can be as high as 90% when performed in highly specialized centers with expert multidisciplinary teams. Unfortunately, a considerable number of BDIs are still managed by injuring non-specialized surgeons in non-tertiary centers with poor surgical outcomes.
The surgical treatment of postcholecystectomy BDI success depends on many factors as the severity of the injury, the centers and surgeon's experiences, the patient's condition, and the reconstruction time. The optimal time for the reconstruction and the patient's condition remains an active topic of interest and debate. Many papers discussed their impact on the short and long-term outcomes with different conflicting results from different institutions.
Theoretically, intra-operative reconstruction of fresh injuries allows an adequate anastomosis and will be associated with the best surgical outcomes. But this is only feasible when BDI is recognized intraoperatively with a surgeon who has sufficient experience to carry out this repair. In most cases, this is far from being the case and is difficult to achieve either due to a small portion of BDIs that is diagnosed intraoperatively or the injuring surgeon who lacks sufficient experience to execute the repair that is almost always going to make an already challenging clinical situation worse.
For postoperative recognized BDI and contrary to the desire of most surgeons, most patients prefer early surgical repair. Early reconstruction (before 6 weeks) may have benefits in terms of reduced burden for the patient and the primary surgeon, avoiding re-admissions, improving patients' quality of life, and decreasing the total healthcare cost. Nevertheless, early reconstruction by which time the patient may be associated with severe local and systemic sepsis, hypoalbuminemia, and friable edematous non-dilated common bile duct (CBD) stump is not preferred by many surgeons for fear of anastomotic failure and bad surgical outcomes. In addition, at the time of an early repair, bile duct ischemia might still be developing, which could later result in anastomotic stricture, especially with associated vascular injuries. On the other hand, many surgeons prefer delayed repair (after 6 weeks) in a less inflamed surgical site with a more defined and properly vascularized duct stump without active sepsis. Taking into consideration that delayed reconstruction may require frequent procedures and repeated admissions as preoperative optimization with subsequent longer total in-hospital stay and increased total healthcare cost. In addition to the difficulty to convince most patients to wait for the delayed reconstruction and its benefits. Recently, many recent papers reported a significant association between adequate preoperative control of abdominal sepsis and reconstruction success rate with no impact of the BDI reconstruction time on the success rate.
Based on the previous data and the absence of guidelines that recommend the timing of BDI reconstruction, the decision for the timing of reconstruction should be based on the predicted success of the operation, costs, and patient quality of life.
If comparable morbidity and mortality outcomes can be obtained, patient quality of life and effective use of healthcare resources should be taken into consideration. We hypothesized that inadequate sepsis control and BDI reconstruction can be done safely at any time of presentation.
Our study aimed to present our experience in the management of major post-cholecystectomy BDI with HJ and analyze the impact of both the reconstruction time and the control of sepsis on the BDI reconstruction success rate. By analyzing the results of these three treatment strategies, we can better understand the factors that affect reconstruction success, costs, and health-related quality of life associated with BDI and subsequent repair.
- Conditions
- Common Bile Duct Injury
- Being tested
- Early BDI reconstruction without abdominal sepsis control, Early BDI reconstruction with abdominal sepsis control, Delayed reconstruction
- Keywords
- bile duct injury, reconstruction time, abdominal sepsis
- Medical subject headings
- Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early BDI reconstruction without abdominal sepsis controlProcedure or surgery
BDI reconstruction within 6 weeks after the injury without abdominal sepsis control
Early BDI reconstruction with abdominal sepsis controlProcedure or surgery
BDI reconstruction within 6 weeks after the injury with abdominal sepsis control
Delayed reconstructionProcedure or surgery
BDI reconstruction after 6 weeks after the injury
| Study group | Role | What they receive |
|---|---|---|
| Early BDI reconstruction without abdominal sepsis control | Experimental | BDI reconstruction within 6 weeks after the injury without controlling the abdominal sepsis Receives: Procedure: Early BDI reconstruction without abdominal sepsis control |
| Early BDI reconstruction with abdominal sepsis control | Experimental | BDI reconstruction within 6 weeks after the injury after controlling the abdominal sepsis Receives: Procedure: Early BDI reconstruction with abdominal sepsis control |
| Delayed reconstruction | Active comparator | BDI reconstruction after 6 weeks after the injury a Receives: Procedure: Delayed reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconstruction success rate
The successful reconstruction was defined as the repair with HJ with no further intervention
Measured: 3 month
Secondary outcomes (9)
Operative time
The time from skin incision to closure
Measured: 5 hours
Blood loss
the total amount of blood loss during the operation
Measured: 5 hours
External stent
The use of external stent for the hepaticojejunostomy reconstruction
Measured: 90 days
Drain-carried time
the number of days before drain removal
Measured: 90 days
Total cost of treatment
The cost of intervention and management of postoperative complications
Measured: 6 month
Return to normal activity
the number of days required for the patient to return to normal activity
Measured: 3 months
Re-intervention
The number of procedures per patient
Measured: 6 months
Hospital stays
the number of admission in the hospital
Measured: 6 months
Patient quality of life
the patient satisfaction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Feb 2014
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 InjuryStudies 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
- 277 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, Ass. prof., Principal investigator, Faculty of medicine, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436626
- Sponsor's protocol ID
- SVU/MED/SUR011/4/22/11/489
- Status last verified
- May 2023
- First submitted
- 23 Jun 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Omar MA, Kamal A, Redwan AA, Alansary MN, Ahmed EA. Post-cholecystectomy major bile duct injury: ideal time to repair based on a multicentre randomized controlled trial with promising results. Int J Surg. 2023 May 1;109(5):1208-1221. doi: 10.1097/JS9.0000000000000403.
PubMed 37072143
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-cholecystectomy Major Bile Duct Injury: Ideal Time to Repair Based on a Multicenter Study With Promising Results.
- ClinicalTrials.gov ID
- NCT05436626
- Acronym / sponsor ID
- SVU/MED/SUR011/4/22/11/489
- Conditions
- Common Bile Duct Injury
- Keywords
- bile duct injury, reconstruction time, abdominal sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 29 Jun 2022 (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.
Bile duct injury (BDI) is one of the devastating recognized complications of cholecystectomy which does not respect the seniority or experience of the surgeon. It has a disastrous impact on long-term survival, health-related quality of life, and healthcare costs as well as high rates of litigation. The incidence of BDI increased with the introduction of laparoscopic cholecystectomy (LC) with an incidence of around 0.3-1.5%.
The initial aim of BDI is to manage abdominal and biliary sepsis and to transform an acute BDI into a controlled external biliary fistula.
The surgical treatment of postcholecystectomy BDI success depends on many factors as the severity of the injury, the centers and surgeon's experiences, the patient's condition, and the reconstruction time. The optimal time for the reconstruction and the patient's condition remains an active topic of interest and debate. Many papers discussed their impact on the short and long-term outcomes with different conflicting results from different institutions.
Based on the previous data and the absence of guidelines that recommend the timing of BDI reconstruction, the decision for the timing of reconstruction should be based on the predicted success of the operation, costs, and patient quality of life. If comparable morbidity and mortality outcomes can be obtained, patient quality of life and effective use of healthcare resources should be taken into consideration. We hypothesized that inadequate sepsis control and BDI reconstruction can be done safely at any time of presentation.
Our study aimed to present our experience in the management of major post-cholecystectomy BDI with HJ and analyze the impact of both the reconstruction time and the control of sepsis on the BDI reconstruction success rate. By analyzing the results of these three treatment strategies, we can better understand the factors that affect reconstruction success, costs, and health-related quality of life associated with BDI and subsequent repair.
Detailed description
Bile duct injury (BDI) is one of the devastating recognized complications of cholecystectomy which does not respect the seniority or experience of the surgeon. It has a disastrous impact on long-term survival, health-related quality of life, and healthcare costs as well as high rates of litigation. Most of these patients are young females, between the ages of 30 and 50 years, with a long life expectancy, and in their most productive years. The incidence of BDI increased with the introduction of laparoscopic cholecystectomy (LC) with an incidence of around 0.3-1.5%; additionally, it results in complete transection. In Egypt, LC is developing rapidly in the primary hospitals that have bad medical conditions and the practicing surgeons have now still beyond the initial learning curve associated with this technique. As a result, the incidence of BDI increased, furthermore the majority were major and complex injuries. Based on the worldwide cholecystectomy frequency, even this low rate of BDI presents a significant potential healthcare burden. Due to this, it is critical that these patients have prompt recognition of their problem and reliable treatment with a long-term success rate. The initial aim of BDI is to manage abdominal and biliary sepsis and to transform an acute BDI into a controlled external biliary fistula. Following this, the severity of the damage should be evaluated. Whereas minor injuries are usually treated with endoscopic or percutaneous intervention, major injuries represent a major challenge even for hepatobiliary surgeons (HBS), and reconstructive surgery by hepaticojejunostomy (HJ) is usually indicated. Successful surgical reconstruction of Type E injuries can be as high as 90% when performed in highly specialized centers with expert multidisciplinary teams. Unfortunately, a considerable number of BDIs are still managed by injuring non-specialized surgeons in non-tertiary centers with poor surgical outcomes.
The surgical treatment of postcholecystectomy BDI success depends on many factors as the severity of the injury, the centers and surgeon's experiences, the patient's condition, and the reconstruction time. The optimal time for the reconstruction and the patient's condition remains an active topic of interest and debate. Many papers discussed their impact on the short and long-term outcomes with different conflicting results from different institutions.
Theoretically, intra-operative reconstruction of fresh injuries allows an adequate anastomosis and will be associated with the best surgical outcomes. But this is only feasible when BDI is recognized intraoperatively with a surgeon who has sufficient experience to carry out this repair. In most cases, this is far from being the case and is difficult to achieve either due to a small portion of BDIs that is diagnosed intraoperatively or the injuring surgeon who lacks sufficient experience to execute the repair that is almost always going to make an already challenging clinical situation worse.
For postoperative recognized BDI and contrary to the desire of most surgeons, most patients prefer early surgical repair. Early reconstruction (before 6 weeks) may have benefits in terms of reduced burden for the patient and the primary surgeon, avoiding re-admissions, improving patients' quality of life, and decreasing the total healthcare cost. Nevertheless, early reconstruction by which time the patient may be associated with severe local and systemic sepsis, hypoalbuminemia, and friable edematous non-dilated common bile duct (CBD) stump is not preferred by many surgeons for fear of anastomotic failure and bad surgical outcomes. In addition, at the time of an early repair, bile duct ischemia might still be developing, which could later result in anastomotic stricture, especially with associated vascular injuries. On the other hand, many surgeons prefer delayed repair (after 6 weeks) in a less inflamed surgical site with a more defined and properly vascularized duct stump without active sepsis. Taking into consideration that delayed reconstruction may require frequent procedures and repeated admissions as preoperative optimization with subsequent longer total in-hospital stay and increased total healthcare cost. In addition to the difficulty to convince most patients to wait for the delayed reconstruction and its benefits. Recently, many recent papers reported a significant association between adequate preoperative control of abdominal sepsis and reconstruction success rate with no impact of the BDI reconstruction time on the success rate.
Based on the previous data and the absence of guidelines that recommend the timing of BDI reconstruction, the decision for the timing of reconstruction should be based on the predicted success of the operation, costs, and patient quality of life.
If comparable morbidity and mortality outcomes can be obtained, patient quality of life and effective use of healthcare resources should be taken into consideration. We hypothesized that inadequate sepsis control and BDI reconstruction can be done safely at any time of presentation.
Our study aimed to present our experience in the management of major post-cholecystectomy BDI with HJ and analyze the impact of both the reconstruction time and the control of sepsis on the BDI reconstruction success rate. By analyzing the results of these three treatment strategies, we can better understand the factors that affect reconstruction success, costs, and health-related quality of life associated with BDI and subsequent repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early BDI reconstruction without abdominal sepsis control | Experimental | Procedure: Early BDI reconstruction without abdominal sepsis controlBDI reconstruction within 6 weeks after the injury without controlling the abdominal sepsis |
| Early BDI reconstruction with abdominal sepsis control | Experimental | Procedure: Early BDI reconstruction with abdominal sepsis controlBDI reconstruction within 6 weeks after the injury after controlling the abdominal sepsis |
| Delayed reconstruction | Active comparator | Procedure: Delayed reconstructionBDI reconstruction after 6 weeks after the injury a |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with BDI within 6 weeks after open or laparoscopic cholecystectomy,
- E1 to E4 BDI,
- Failed stenting with endoscopic retrograde cholangiopancreatography (ERCP),
- American Society of Anesthesiologists (ASA) score I-III,
- Agreement to complete the study
Key exclusion criteria (3 listed)
- Advanced liver cirrhosis.
- Benign or malignant bile duct stricture.
- concomitant vascular and visceral injury
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 BDI reconstruction without abdominal sepsis controlBDI reconstruction within 6 weeks after the injury without abdominal sepsis control | Procedure or surgery | Early BDI reconstruction without abdominal sepsis control |
| Early BDI reconstruction with abdominal sepsis controlBDI reconstruction within 6 weeks after the injury with abdominal sepsis control | Procedure or surgery | Early BDI reconstruction with abdominal sepsis control |
| Delayed reconstructionBDI reconstruction after 6 weeks after the injury | Procedure or surgery | Delayed reconstruction |
Primary outcome
Reconstruction success rate
Time frame: 3 month
The successful reconstruction was defined as the repair with HJ with no further intervention
9 secondary outcomes
Operative time
Time frame: 5 hours
Blood loss
Time frame: 5 hours
External stent
Time frame: 90 days
Drain-carried time
Time frame: 90 days
Total cost of treatment
Time frame: 6 month
Return to normal activity
Time frame: 3 months
Re-intervention
Time frame: 6 months
Hospital stays
Time frame: 6 months
Patient quality of life
Time frame: 6 months
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 16 May 2023.
- Derived from this study: PubMed 37072143Omar MA, Kamal A, Redwan AA, Alansary MN, Ahmed EA. Post-cholecystectomy major bile duct injury: ideal time to repair based on a multicentre randomized controlled trial with promising results. Int J Surg. 2023 May 1;109(5):1208-1221. doi: 10.1097/JS9.0000000000000403.
- Individual participant dataSharing planned: No
Related trials for Common Bile Duct Injury
Recruiting
Early vs Late Laparoscopic Cholecystectomy After Common Bile Duct Stones Clearance Through Ercp.
Laparoscopic Cholecystectomy, Choledocholithiasis
Recruiting
Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage
Bile Duct; Obstruction, With Calculus, Choledocholithiasis
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
Faculty of medicine, South Valley University
Questions about this trial
What is this clinical trial studying?
A study testing Delayed reconstruction in people with Common Bile Duct Injury, run by South Valley University.
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 5 inclusion and 3 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Reconstruction success rate (time frame: 3 month). 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 NCT05436626, 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 16 May 2023.