ClinicalTrials.gg
CompletedNCT05436626Updated May 16, 2023

Post-cholecystectomy Major Bile Duct Injury

An interventional study of Early BDI reconstruction without abdominal sepsis control and Early BDI reconstruction with abdominal sepsis control in Common Bile Duct Injury, sponsored by South Valley University. Completed. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by South Valley University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 years 4 months after the study started (first participant enrolled Feb 2014, registered Jun 2022).

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Phase
Not applicable
Study type
Interventional
Enrollment
277
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Common Bile Duct Injury

Keywords

  • bile duct injury
  • reconstruction time
  • abdominal sepsis
03

In context

Intraabdominal Infections

129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.

This study's enrollment of 277 is above the median of 140 across 77 interventional studies indexed under Intraabdominal Infections.

Browse Intraabdominal Infections studies →

Lead sponsor

South Valley University is the lead sponsor of 153 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients diagnosed with BDI within 6 weeks after open or laparoscopic cholecystectomy,
  2. E1 to E4 BDI,
  3. Failed stenting with endoscopic retrograde cholangiopancreatography (ERCP),
  4. (ASA) score I-III,
  5. Agreement to complete the study

Exclusion criteria

Exclusion Criteria:

  1. Advanced liver cirrhosis.
  2. Benign or malignant bile duct stricture.
  3. concomitant vascular and visceral injury
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
277 participants (actual)

Study arms

  • Experimental
    Early BDI reconstruction without abdominal sepsis control

    BDI reconstruction within 6 weeks after the injury without controlling the abdominal sepsis

    Procedure: Early BDI reconstruction without abdominal sepsis control

  • Experimental
    Early BDI reconstruction with abdominal sepsis control

    BDI reconstruction within 6 weeks after the injury after controlling the abdominal sepsis

    Procedure: Early BDI reconstruction with abdominal sepsis control

  • Active comparator
    Delayed reconstruction

    BDI reconstruction after 6 weeks after the injury a

    Procedure: Delayed reconstruction

Interventions

  • ProcedureEarly BDI reconstruction without abdominal sepsis control

    BDI reconstruction within 6 weeks after the injury without abdominal sepsis control

  • ProcedureEarly BDI reconstruction with abdominal sepsis control

    BDI reconstruction within 6 weeks after the injury with abdominal sepsis control

  • ProcedureDelayed reconstruction

    BDI reconstruction after 6 weeks after the injury

06

What researchers measure

Primary outcomes

  1. Reconstruction success rate

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

    Time frame: 3 month

Secondary outcomes

  1. Operative time

    The time from skin incision to closure

    Time frame: 5 hours

  2. Blood loss

    the total amount of blood loss during the operation

    Time frame: 5 hours

  3. External stent

    The use of external stent for the hepaticojejunostomy reconstruction

    Time frame: 90 days

  4. Drain-carried time

    the number of days before drain removal

    Time frame: 90 days

  5. Total cost of treatment

    The cost of intervention and management of postoperative complications

    Time frame: 6 month

  6. Return to normal activity

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

    Time frame: 3 months

  7. Re-intervention

    The number of procedures per patient

    Time frame: 6 months

  8. Hospital stays

    the number of admission in the hospital

    Time frame: 6 months

  9. Patient quality of life

    the patient satisfaction

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2014 to primary completion in Jan 2022, 95 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2022
First posted
Jun 29, 2022
StartActual
Feb 1, 2014
Primary completionActual
Jan 31, 2022
CompletionActual
Jan 31, 2022
Last update
May 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05436626
Responsible party
Mohammed Ahmed Omar, MD (Associate professor of surgery, South Valley University) — Principal investigator
First posted
Jun 29, 2022
Start date
Feb 1, 2014
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022
Last update
May 16, 2023

Study contacts

Mohammed A. Omar, Ass. prof.
principal investigator · Faculty of medicine, South Valley University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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