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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
The common hepatic duct was cut and the duodenal side is closed by suture. The small intestine was cut off 15 cm below the ligament of Treitz. The distal end was lifted, and a 1-2 cm incision was made at the jejunal wall 4-5 cm from the jejunal stump. The anastomosis is used a 5-0 PSD Ⅱ suture, with double needles, inside-out in the jejunum and outside-in in the hepatic duct. One side of needles was used to continuely penetrate and suture the whole layer of the posterior-lateral wall of the jejunum, the posterior-lateral wall of the biliary duct, and the other side of needles was used to continuely stuere the anterior part of the anastomosis. Mucosa-to-mucosa contact should be ensured with every stitch.The anastomotic stomas were then checked for leakage. Enteric-enteric anastomosis was performed 60 cm below the site of the hepatojejunal anastomosis.
The T-tube was placed for biliary drainage and the common bile duct was intermittently sutured with 4-0 vicryl sutures.
stone recurrence rate
A recurrence stone was defined as a stone detected more than 3 months after surgery by any diagnostic method. (%)
Time frame: 3 years
biliary stricturer rate
Biliary stricture defined as clinically evident stenosis and subclinical stenosis proved by endoscopic examination or reoperation (%)
Time frame: 3 years
Cholangitis rate
The diagnosis of cholangitis is based on clinically evident (abdominal discomfort/pain, jaundice or fever associated with hepatolithiasis (%)
Time frame: 3 years
sphincter of oddi function
Grading criteria for the SO function were as follows: Normal; Laxity and Loss of function
Time frame: an expected average of 120 minutes
Mortality
Operative mortality was defined as any death resulting from a complication during surgery
Time frame: 90 days
Biliary leakage
Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems
Time frame: 90 days
total bilirubin
serum total bilirubin on 3 postoperative day (umol/L)
Time frame: 90 days
quality of life grading
Quality of life will be assessed by Visick score (Ⅰ～Ⅳ).
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Time frame: 3 years