Post-cholecystectomy Major Bile Duct Injury
Condition: Common Bile Duct Injury
MeSH terms: Postcholecystectomy Syndrome; Wounds and Injuries
Study type: Interventional

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.
    

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.
    

Intervention name(s): Early BDI reconstruction without abdominal sepsis control; Early BDI reconstruction with abdominal sepsis control; Delayed reconstruction
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): BDI reconstruction within 6 weeks after the injury without abdominal sepsis control; BDI reconstruction within 6 weeks after the injury with abdominal sepsis control; BDI reconstruction after 6 weeks after the injury
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bile duct injury; reconstruction time; abdominal sepsis