Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy

NCT04134546 | Unknown

• 1 other identifier: biliary tract injury
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bile duct injury following cholecystectomy is an iatrogenic catastrophe associated with significant peri operative morbidity and mortality(1, 2) reduced long term survival(3) and quality of life(4, 5) and high rates of subsequent litigation6. It should be regarded as preventable. The advent of laparoscopic cholecystectomy has resulted in a resurgence of interest in bile duct injury and its subsequent management. Population based studies(6.7) suggest a significant increase in the incidence of injury (0•1 to 0•5 per cent) following the implementation of the laparoscopic approach(8) Bile duct injury should be regarded as preventable, but over 70 per cent of surgeons regard it as unavoidable(9). Although most injuries occur within the surgeon's first 100 laparoscopic cholecystectomies, one third happen after the surgeon has performed more than 200; it is more than inexperience that leads to bile duct injury(10). It has been suggested that the commonest cause of common bile duct injury is misidentification of biliary anatomy (70-80 per cent of injuries)(11,12),a reduction in risk if surgeons perform routine intraoperative cholangiography Recognition of bile duct injury at the time of cholecystectomy allows an opportunity for the hepatobiliary surgeon to assess its severity and the presence of any vascular injury

Conditions

Biliary Fistula

Outcome Measures

Primary Outcomes (1)

• faliure of interventon

  By mesurment liver functon as direct billirubin

  two months

Secondary Outcomes (1)

• plan for improving

  two months

Study Arms (1)

group with biliary injury

EXPERIMENTAL

group for Early versus late intervention after biliary tract injury post cholecystectomy

Procedure: CBD exoloration

Interventions

CBD exoloration PROCEDURE

Early versus late intervention after biliary tract injury post cholecystectomy

group with biliary injury

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with post cholecystectomy biliary tract injury admitted at Assuit university hospital at the period of the study

You may not qualify if:

• Any case with biliary leakage not post cholecystectomy

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Biliary Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at general surgery department

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 22, 2019
• Study Start: October 30, 2019
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: October 22, 2019

Record last verified: 2019-10