Bile Duct InjuryNCT05243225
Laparoscopic Versus Open Surgical Management of Post Cholecystectomy Bile Duct Injury
An observational study of Bile Duct Injury, run by Assiut University.
Trial summary
Comparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury. Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bile Duct Injury
- What is being tested?
- Laparoscopic versus open surgical management of post cholecystectomy bile duct injury
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Jan 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with bile duct injury post cholecystectomy
Who may be able to join
- All patients with post cholecystectomy bile duct injuries admitted to surgery department in Asyut University Hospitals and El-Rajhi hospital at the period of the study.
- Patients fit for surgery.
- Patients informed consent for study.
- Patients with signs and symptoms due to Bile duct injury like abdominal pain, jaundice and high liver function parameters
Who cannot join
- Unfit cases for laparoscopic surgery.
- Unfit patients for open surgery.
- Patients refuse consent to participate in the study.
- Patients who had previous repair.
- Patients who present with abdominal sepsis.
Trial locations and contacts
No sites are listed yet.
About this study
Comparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury.
Read the detailed description
Bile duct injury (BDI) post cholecystectomy is an iatrogenic catastrophe associated with significant morbidity , mortality and poor quality of life this is due to the large number of cholecystectomies per year all over the world. Cholecystectomy whether open or laparoscopic is done in large number about 750,000 annually in USA, the incidence of BDI post cholecystectomy is about 0.1-0.2% in open cholecystectomy and 0.4-0.6% in laparoscopic cholecystectomy although the percentage appears small but it still large number about 2100 patients per year. The two most frequent scenarios of BDI may be occurrence of bile leak or bile duct obstruction. Early recognition of iatrogenic bile duct injury is essential to prevent major morbidity by imaging techniques, such as Ultrasound and CT which are extremely valuable during the initial evaluation but MRCP remains the gold standard for diagnosis. ERCP can confirm the presence of biliary injury and provides a means for definitive management. The main aim of surgical treatment is the reconstruction of proper flow of bile to the alimentary tract. Repair of such injuries still remains a challenge due to the variety of size of injury, site of injury if proximal or distal, the severity of injury and the time of presentation after the injury. Repair of such BDI may be done by laparoscopy or by open surgery which still a matter of debate. There are many described techniques should be done by specialized hepatobiliary surgeon from simple repair, repair over T-tube up to hepaticojejunostomy. Despite widespread advances in laparoscopic surgery, laparoscopic repair of post-cholecystectomy bile duct injury (BDI) has rarely been reported related mainly to technical difficulty.
- Conditions
- Bile Duct Injury
- Being tested
- Laparoscopic versus open surgical management of post cholecystectomy bile duct injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic versus open surgical management of post cholecystectomy bile duct injuryProcedure or surgery
Comparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic management of post cholecystectomy bile duct injury. | Under general intubation anaesthesia, trocars are inserted in the abdomen, insufflation by CO2 adhesiolysis is performed to reach the bile duct. Evaluation by intraoperative cholangiogram then according to the site and the size of the injury repair will done. If the injury is small simple repair or repair on T-tube will be done. If the injury is large repair on T-tube or hepaticojejunostomy will be done .If it is a distal injury repair on T-tube or biloenteric shunt will be done .If the injury is proximal biloenteric shunt will be done. Intra-abdominal drains insertion Receives: Procedure: Laparoscopic versus open surgical management of post cholecystectomy bile duct injury | |
| open surgical management of post cholecystectomy bile duct injury. | Under general intubation anaesthesia, a generous right subcostal incision is performed and could be extended on demand upward to the xiphoid process and/or to the left subcostal area. Thorough dissection and adhesiolysis is performed to reach the bile duct. Evaluation by intraoperative cholangiogram according to the site and the size of the injury repair will be done. If the injury is small simple repair or repair on T-tube will be done . If the injury is large repair on T-tube or hepaticojejunostomy will be done .If it is a distal injury repair on T-tube or biloenteric shunt will be done .If the injury is proximal biloenteric shunt will be done .Intra-abdominal drains insertion. Receives: Procedure: Laparoscopic versus open surgical management of post cholecystectomy bile duct injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between outcomes of laparoscopic and open surgical management of post cholecystectomy bile duct injury.
Analysis of efficacy of repair in laparoscopic and open surgical management of post cholecystectomy bile duct injury
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study startJun 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir William Samir Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243225
- Sponsor's protocol ID
- BDI repair
- Status last verified
- Jun 2023
- First submitted
- 26 Oct 2021
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Surgical Management of Post Cholecystectomy Bile Duct Injury
- ClinicalTrials.gov ID
- NCT05243225
- Acronym / sponsor ID
- BDI repair
- Conditions
- Bile Duct Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 17 Feb 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.
Comparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury.
Detailed description
Bile duct injury (BDI) post cholecystectomy is an iatrogenic catastrophe associated with significant morbidity , mortality and poor quality of life this is due to the large number of cholecystectomies per year all over the world. Cholecystectomy whether open or laparoscopic is done in large number about 750,000 annually in USA, the incidence of BDI post cholecystectomy is about 0.1-0.2% in open cholecystectomy and 0.4-0.6% in laparoscopic cholecystectomy although the percentage appears small but it still large number about 2100 patients per year. The two most frequent scenarios of BDI may be occurrence of bile leak or bile duct obstruction. Early recognition of iatrogenic bile duct injury is essential to prevent major morbidity by imaging techniques, such as Ultrasound and CT which are extremely valuable during the initial evaluation but MRCP remains the gold standard for diagnosis. ERCP can confirm the presence of biliary injury and provides a means for definitive management. The main aim of surgical treatment is the reconstruction of proper flow of bile to the alimentary tract. Repair of such injuries still remains a challenge due to the variety of size of injury, site of injury if proximal or distal, the severity of injury and the time of presentation after the injury. Repair of such BDI may be done by laparoscopy or by open surgery which still a matter of debate. There are many described techniques should be done by specialized hepatobiliary surgeon from simple repair, repair over T-tube up to hepaticojejunostomy. Despite widespread advances in laparoscopic surgery, laparoscopic repair of post-cholecystectomy bile duct injury (BDI) has rarely been reported related mainly to technical difficulty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic management of post cholecystectomy bile duct injury. | – | Procedure: Laparoscopic versus open surgical management of post cholecystectomy bile duct injuryUnder general intubation anaesthesia, trocars are inserted in the abdomen, insufflation by CO2 adhesiolysis is performed to reach the bile duct. Evaluation by intraoperative cholangiogram then according to the site and the size of the injury repair will done. If the injury is small simple repair or repair on T-tube will be done. If the injury is large repair on T-tube or hepaticojejunostomy will be done .If it is a distal injury repair on T-tube or biloenteric shunt will be done .If the injury is proximal biloenteric shunt will be done. Intra-abdominal drains insertion |
| open surgical management of post cholecystectomy bile duct injury. | – | Procedure: Laparoscopic versus open surgical management of post cholecystectomy bile duct injuryUnder general intubation anaesthesia, a generous right subcostal incision is performed and could be extended on demand upward to the xiphoid process and/or to the left subcostal area. Thorough dissection and adhesiolysis is performed to reach the bile duct. Evaluation by intraoperative cholangiogram according to the site and the size of the injury repair will be done. If the injury is small simple repair or repair on T-tube will be done . If the injury is large repair on T-tube or hepaticojejunostomy will be done .If it is a distal injury repair on T-tube or biloenteric shunt will be done .If the injury is proximal biloenteric shunt will be done .Intra-abdominal drains insertion. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with bile duct injury post cholecystectomy
Key inclusion criteria (4 listed)
- All patients with post cholecystectomy bile duct injuries admitted to surgery department in Asyut University Hospitals and El-Rajhi hospital at the period of the study.
- Patients fit for surgery.
- Patients informed consent for study.
- Patients with signs and symptoms due to Bile duct injury like abdominal pain, jaundice and high liver function parameters
Key exclusion criteria (5 listed)
- Unfit cases for laparoscopic surgery.
- Unfit patients for open surgery.
- Patients refuse consent to participate in the study.
- Patients who had previous repair.
- Patients who present with abdominal sepsis.
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 |
|---|---|---|
| Laparoscopic versus open surgical management of post cholecystectomy bile duct injuryComparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury. | Procedure or surgery | laparoscopic management of post cholecystectomy bile duct injury., open surgical management of post cholecystectomy bile duct injury. |
Primary outcome
Comparison between outcomes of laparoscopic and open surgical management of post cholecystectomy bile duct injury.
Time frame: Baseline
Analysis of efficacy of repair in laparoscopic and open surgical management of post cholecystectomy bile duct injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Injury, run by Assiut 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact amir william samir fahmy, resident (+201119958633, amirwilliam8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between outcomes of laparoscopic and open surgical management of post cholecystectomy bile duct injury. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2023.