Obstruction of bile duct. Obstruction of bile duct
Conditions
Interventions
Intervention 1: Intervention Group: N-acetylcysteine infusion for the first 48 hours plus standard treatment (hydration plus antibiotics after the surgery). Intervention 2: Control Group: Standard tre
Treatment - Drugs
Intervention Group: N-acetylcysteine infusion for the first 48 hours plus standard treatment (hydration plus antibiotics after the surgery)
Control Group: Standard treatment only (hydration plus antibiotics after the surgery)
Sponsors
Tabriz University of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Age above 18 years and below 75; unable to treta with ERCP or radiologic intervention; common bile diameter over 10 mm; no indication for resection of obstructive jaundice (choledochal cyst or Whipple procedure); bilirubin level over 5 mg/dl Exclusion criteria: possibility of surgical resection (Whipple procedure or bile duct tumor resection); any contraindication for acetylcysteine injection (e.g. asthma, bronchospasm, angioedema or known hypersensitivity); liver cirrhosis or need for liver transplant according to clinical or surgical findings for any reason; known renal failure or heart failure; need for mechanical ventilation before surgery, septic shock resistant to inotrope ( Systolic blood pressure less than 90) before surgery; preoperative biliary drainage by ERCP or radiologic intervention; liver enzymes (ALT, AST) greater than 10 times the normal; acute viral hepatitis or any history of drug toxicity; known liver disease such as autoimmune hepatitis; hemolysis cases
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aspartate aminotransferase. Timepoint: Preoperative and postoperative days 1, 3, 5, 7, 10, 14, and 30. Method of measurement: Measurement of serum level.;Alanine aminotransferase. Timepoint: Preoperative and postoperative days 1, 3, 5, 7, 10, 14, and 30. Method of measurement: Measurement of serum level.;Alkaline phosphatase. Timepoint: Preoperative and postoperative days 1 3 .5 .7 .10 .14. Method of measurement: Measurement of serum level.;Bilirubin. Timepoint: Preoperative and postoperative days 1, 3, 5, 7, 10, 14, and 30. Method of measurement: Measurement of serum level.;INR. Timepoint: Preoperative and postoperative days 1, 3, 5, 7, 10, 14, and 30. Method of measurement: Blood test.;Gamma glutamyl transferase. Timepoint: Preoperative and postoperative days 1 3 5 .7 .10 .14. Method of measurement: Measurement of serum level.;Blood urea nitrogen. Timepoint: Preoperative and postoperative days 1, 3, 5, 7, 10, 14, and 30. Method of measurement: Measurement of serum level.;Creatinine. Timepoint: Preoperative and postoperative days 1 3 5 .7 .10 .14. Method of measurement: Measurement of serum level. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality. Timepoint: Up to 30 days after surgery. Method of measurement: From clinical records and postdischarge follow up.;Need for dialysis. Timepoint: After the operation time up to 30 days after surgery. Method of measurement: By clinical records and postdischarge followup.;Need for mechanical ventilation. Timepoint: up to 30 days after surgery. Method of measurement: By clinical records and postdischarge followup.;Pneumonia. Timepoint: After the operation till discharge. Method of measurement: By clinical records.;Need for inotropes. Timepoint: After the operation till discharge. Method of measurement: By clinical records.;Need for liver transplantation. Timepoint: After the operation till discharge or death. Method of measurement: By clinical records.;Hepatic encephalopathy. Timepoint: After the operation till discharge or death. Method of measurement: By clinical records. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Farzad Kakaei
Tabriz University of Medical ScienceS
Outcome results
None listed