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COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Improvement of percutaneous transhepatic biliary internal-external drainage and its initial experience in patients with malignant obstruction of the upper biliary tree.
BACKGROUND/AIMS: To evaluate the feasibility and clinical results of modified percutaneous transhepatic biliary internal-external drainage (PTBIED) vs. conventional PTBIED in patients with malignant biliary obstruction.
METHODOLOGY: Conventional PTBIED was modified by applying side-holes to an 8.5Fr external biliary drainage catheter. Eligible patients were randomly assigned 1:1 by the doctors to receive modified PTBIED (group A) or conventional PTBIED (group B). Technical success rate, complications, hepatic function and white cell count were recorded pre- and post-procedure. All patients were followed-up until death.
RESULTS: Twenty-two patients were assigned in group A and 21 patients were involved in group B. Successful drainage was all achieved in both groups. Biliary tract infections were significantly reduced in group A (1/22) compared to group B (7/21, p<0.05). The leukocyte count fell slightly in group A post-procedure, while it rose in group B (group A: 8.45±3.22-109/L to 7.53±2.46-109/L; group B: 7.92±3.08-109/L to 10.52±5.09-109/L). Both procedures had similar effects in the recovery of hepatic function, median survival time and alleviating clinical symptoms (such as pruritis and abdominal pain).
CONCLUSIONS: Modified PTBIED can reduce the complications resulting from retrograde reflux of duodenal contents. Improved PTBIED should be used for patients with inoperable high malignant biliary obstruction.
METHODOLOGY: Conventional PTBIED was modified by applying side-holes to an 8.5Fr external biliary drainage catheter. Eligible patients were randomly assigned 1:1 by the doctors to receive modified PTBIED (group A) or conventional PTBIED (group B). Technical success rate, complications, hepatic function and white cell count were recorded pre- and post-procedure. All patients were followed-up until death.
RESULTS: Twenty-two patients were assigned in group A and 21 patients were involved in group B. Successful drainage was all achieved in both groups. Biliary tract infections were significantly reduced in group A (1/22) compared to group B (7/21, p<0.05). The leukocyte count fell slightly in group A post-procedure, while it rose in group B (group A: 8.45±3.22-109/L to 7.53±2.46-109/L; group B: 7.92±3.08-109/L to 10.52±5.09-109/L). Both procedures had similar effects in the recovery of hepatic function, median survival time and alleviating clinical symptoms (such as pruritis and abdominal pain).
CONCLUSIONS: Modified PTBIED can reduce the complications resulting from retrograde reflux of duodenal contents. Improved PTBIED should be used for patients with inoperable high malignant biliary obstruction.
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