Bile suppletion as adjuvant therapy in the treatment of iatrogenic bile duct injury after cholecystectomy: a bitter necessity?

• Conditions: 10003018; Bile duct damage; Bile duct injury; 10004606; 10069888

• Registration Number: NL-OMON30074
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

-Older than 18 years of age
-Total or partial iatrogenic damage of the biliary tract after cholecystectomy, leading to biliary drainage and subsequent need for surgical reconstruction.
-Patients are included in the study after signing informed consent.

Exclusion Criteria

-Malignancies of the biliary tract
-Malignancies of the pancreas
-Unwillingness to receive bile restitution
-Cholangitis (bacterial contamination of the bile)
-Insufficient bile-drain production < 100 ml per 24 hours
-Age < 18 years
-Inability to write or read the Dutch language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Body weight expressed in Kilogrammes.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Body Mass Index (BMI),<br /><br>- Body composition expressed in fat-mass, lean body mass, handgrip strength and<br /><br>mid-arm muscular circumference (MAMC),<br /><br>- Nutritional intake expressed in macronutrients, micronutrients and fluids,<br /><br>- Stability of Cl, K, Na, Ca, Fe and cholesterol plasma values.<br /><br>- Quality of life measured by SF-36 and GiQLi,<br /><br>- Incidence of nausea, intestinal cramps, intestinal pain and diarrhoea and<br /><br>sepsis. </p><br>