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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT05436626
Study groupRoleWhat they receive
Early BDI reconstruction without abdominal sepsis controlExperimentalBDI 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 controlExperimentalBDI reconstruction within 6 weeks after the injury after controlling the abdominal sepsis
Receives: Procedure: Early BDI reconstruction with abdominal sepsis control
Delayed reconstructionActive comparatorBDI 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.

  1. Reconstruction success rate

    The successful reconstruction was defined as the repair with HJ with no further intervention

    Measured: 3 month

Secondary outcomes (9)
  1. Operative time

    The time from skin incision to closure

    Measured: 5 hours

  2. Blood loss

    the total amount of blood loss during the operation

    Measured: 5 hours

  3. External stent

    The use of external stent for the hepaticojejunostomy reconstruction

    Measured: 90 days

  4. Drain-carried time

    the number of days before drain removal

    Measured: 90 days

  5. Total cost of treatment

    The cost of intervention and management of postoperative complications

    Measured: 6 month

  6. Return to normal activity

    the number of days required for the patient to return to normal activity

    Measured: 3 months

  7. Re-intervention

    The number of procedures per patient

    Measured: 6 months

  8. Hospital stays

    the number of admission in the hospital

    Measured: 6 months

  9. 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.

  1. First posted29 Jun 2022
  2. Study start1 Feb 2014
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

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)
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

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.

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