Sphincter of Oddi Laxity Clinical Trial
Official title:
A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity
Residual and recurrent stones remain one of the most important challenges of hepatolithiasis which is reported in 20% to 50% of patients treated with these therapies. Up to now the most two common surgical procedures performed were choledochojejunostomy and T tube drainage as biliary drainage in hepatolithiasis. The goal of the present study was to evaluate the therapeutic safety, and perioperative and long-term outcomes of choledochojejunostomy versus T tube drainage for hepatolithiasis with sphincter of Oddi laxity.
Background: SOL results in reflux of duodenal fluid and enteric bacteria infection, which
lead to the formation of stones in the biliary tract. Roux-en-Y hepaticojejunostomy (HJ)
shows considerable advantage for prevention of reflux of intestinal content into the bile
duct. As a result, A randomized controlled trial (RCT) evaluate the therapeutic safety, and
perioperative and long-term outcomes of HJ versus T tube drainage for hepatolithiasis with
SOL.
Intervention: In total, 210 patients who met the following eligibly criteria were included
and were randomized to choledochojejunostomy arm or T tube drainage in a 1:1 ratio.
Clinical data include: the incidence of biliary complications (stone recurrence; biliary
stricture; cholangitis); sphincter of oddi function; biliary leakage; mortality; hepatic
injury; quality of life.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01459549 -
Randomized Controlled Trial of Treating Hepatolithiasis (Accompanied With SOL) With Choledochojejunostomy
|
N/A |