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Post-cholecystectomy Major Bile Duct Injury

Primary Purpose

Common Bile Duct Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early BDI reconstruction without abdominal sepsis control
Early BDI reconstruction with abdominal sepsis control
Delayed reconstruction
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Injury focused on measuring bile duct injury, reconstruction time, abdominal sepsis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. American Society of Anesthesiologists (ASA) score I-III,
  5. Agreement to complete the study

Exclusion Criteria:

  1. Advanced liver cirrhosis.
  2. Benign or malignant bile duct stricture.
  3. concomitant vascular and visceral injury

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Early BDI reconstruction without abdominal sepsis control

    Early BDI reconstruction with abdominal sepsis control

    Delayed reconstruction

    Arm Description

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

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

    BDI reconstruction after 6 weeks after the injury a

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Operative time
    The time from skin incision to closure
    Blood loss
    the total amount of blood loss during the operation
    External stent
    The use of external stent for the hepaticojejunostomy reconstruction
    Drain-carried time
    the number of days before drain removal
    Total cost of treatment
    The cost of intervention and management of postoperative complications
    Return to normal activity
    the number of days required for the patient to return to normal activity
    Re-intervention
    The number of procedures per patient
    Hospital stays
    the number of admission in the hospital
    Patient quality of life
    the patient satisfaction

    Full Information

    First Posted
    June 23, 2022
    Last Updated
    May 13, 2023
    Sponsor
    South Valley University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05436626
    Brief Title
    Post-cholecystectomy Major Bile Duct Injury
    Official Title
    Post-cholecystectomy Major Bile Duct Injury: Ideal Time to Repair Based on a Multicenter Study With Promising Results.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2014 (Actual)
    Primary Completion Date
    January 31, 2022 (Actual)
    Study Completion Date
    January 31, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    South Valley University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Common Bile Duct Injury
    Keywords
    bile duct injury, reconstruction time, abdominal sepsis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    277 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Early BDI reconstruction without abdominal sepsis control
    Arm Type
    Experimental
    Arm Description
    BDI reconstruction within 6 weeks after the injury without controlling the abdominal sepsis
    Arm Title
    Early BDI reconstruction with abdominal sepsis control
    Arm Type
    Experimental
    Arm Description
    BDI reconstruction within 6 weeks after the injury after controlling the abdominal sepsis
    Arm Title
    Delayed reconstruction
    Arm Type
    Active Comparator
    Arm Description
    BDI reconstruction after 6 weeks after the injury a
    Intervention Type
    Procedure
    Intervention Name(s)
    Early BDI reconstruction without abdominal sepsis control
    Intervention Description
    BDI reconstruction within 6 weeks after the injury without abdominal sepsis control
    Intervention Type
    Procedure
    Intervention Name(s)
    Early BDI reconstruction with abdominal sepsis control
    Intervention Description
    BDI reconstruction within 6 weeks after the injury with abdominal sepsis control
    Intervention Type
    Procedure
    Intervention Name(s)
    Delayed reconstruction
    Intervention Description
    BDI reconstruction after 6 weeks after the injury
    Primary Outcome Measure Information:
    Title
    Reconstruction success rate
    Description
    The successful reconstruction was defined as the repair with HJ with no further intervention
    Time Frame
    3 month
    Secondary Outcome Measure Information:
    Title
    Operative time
    Description
    The time from skin incision to closure
    Time Frame
    5 hours
    Title
    Blood loss
    Description
    the total amount of blood loss during the operation
    Time Frame
    5 hours
    Title
    External stent
    Description
    The use of external stent for the hepaticojejunostomy reconstruction
    Time Frame
    90 days
    Title
    Drain-carried time
    Description
    the number of days before drain removal
    Time Frame
    90 days
    Title
    Total cost of treatment
    Description
    The cost of intervention and management of postoperative complications
    Time Frame
    6 month
    Title
    Return to normal activity
    Description
    the number of days required for the patient to return to normal activity
    Time Frame
    3 months
    Title
    Re-intervention
    Description
    The number of procedures per patient
    Time Frame
    6 months
    Title
    Hospital stays
    Description
    the number of admission in the hospital
    Time Frame
    6 months
    Title
    Patient quality of life
    Description
    the patient satisfaction
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Advanced liver cirrhosis. Benign or malignant bile duct stricture. concomitant vascular and visceral injury
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammed A. Omar, Ass. prof.
    Organizational Affiliation
    Faculty of medicine, South Valley University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Post-cholecystectomy Major Bile Duct Injury

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