Multi-factor Analysis Of Short-term Palliation Efficacy Of Percutaneous Transhepatic Biliary Drainage And Stenting For Malignant Obstructive Jaundice

BackgroundMalignant obstructive jaundice (MOJ) is a group of mechanical bile duct obstruction due to malignant disease of the bile duct lumen and wall or the outer of bile duct, including cholangiocarcinoma, gallbladder cancer, hepatocellular carcinoma, ampullary carcinoma, pancreatic cancer and metastatic cancer, and so on. These tumors are often accompanied by blocking the proximal bile duct resulting in biliary tract dilatation and infection. Along with the obstruction, the inside pressure of bile duct and endothelial cell permeability increase and bilirubin enter into the blood, which can cause obstructive jaundice, sepsis, biliary cirrhosis, liver failure and hepatorenal syndrome, etc.In general, surgery is still the most important and radical approach to treat malignant obstructive jaundice. Surgical approaches mainly include removal of lesions and surgical bile duct drainage. But malignant obstructive jaundice is found mostly when the tumors are on the advanced stage. Only 7% patients can suffer radical surgery and only 19% can be done by palliative biliary-enteric anastomosis. The incidence rate of postoperative complications and postoperative mortality are higher. For those patients with unresectable disease, progressive jaundice constitutes an immediate limitation to their survival and causes significant loss to their quality of life secondary to pruritis, malaise and cholangitis with the patients'average survival time less than 3 months. Effective and lasting decompression of the biliary tree is a priority therapeutic method including biliary drainage and placement of biliary stent. These procedures could be finished by these minimally invasive techniques: percutaneous transhepatic biliary drainage/stenting (PTBD and PTBS) and endoscopic retrograde biliary drainage (ERBD). Compared to surgery, patient can often be treated under moderate sedation with a short hospital stay.In the last sixty years, the procedure of PTBD and PTBS has been progressing in skills and materials, and now has been the most important palliative technique in the treatment of MOJ because of its higher successful rate and better therapeutic effect comparing with ERBD.PTBD and PTBS can reach a better relieving effect for MOJ. But in clinical, we found sometimes that PTBD and PTBS did not work as we expected, and the degree of palliation differed largely in these patients. So we thought there could be other influential factors.Depending on clinical experience, characteristic of bile duct diseases and selected literatures, this study will discuss the influence factors of palliative effect of PTBD and PTBS from aspects of characteristic of imaging and chemical analysis, diseased and therapeutic conditions, and complications.ObjectiveThe purpose of the present study is to evaluate short-term palliative effect of PTBD and PTBS in MOJ, and to describe the influence factors of this palliative therapy.Materials and Methods111 cases of MOJ (,range 20-82 years, mean age 61.6 years) between May 2005 and June 2009 underwent clinical assessment. They were diagnosed as cholangiocarcinoma (n=52 cases,46.8%), pancreatic carcinoma (n=22,19.8%), gallbladder carcinoma (n=6,5.4%), liver cancer (n=8,7.2%), periampulllary carcinoma (n=7,6.3%), metastatic carcinoma of head pancreas (n=7,6.3%), metastatic carcinoma of hepatic hilum (n= 9,8.1%). Clinical analysis had been done in all cases through history-taking, physical examination, blood chemical and ultrasound or CT or magnetic resonance imaging examination. Serum total bilirubin exceeded 60 umol/L in 111 patients.PTBD and PTBS was carried out in all patients, including 8.5F multi-lateral holes drainage tubes (COOK, USA) or bare metal stent (8mm or 10 mm diameter) placement.Eighteen influence factors were recorded, which may be related to the palliative efficacy of MOJ, including perioperatively total bilirubin, direct bilirubin (DB), indirect bilirubin (IB), serum albumin (ALB), prothrombin time (PT), the degree of bile duct dilatation, location and length of stricture involving Bismuth type for hepatic hilar lesions, unilateral or bilateral drainage, the duration of jaundice, ascites, preoperative and post-operative suppurative cholangiti, bile duct bleeding after procedure, and so on. It is regarded as effective treatment that the total bilirubin decreased more than 30% on the 7th day after operation, based on Tian fuzhou palliative efficacy criterion. Multifactors analysis was done to explain whether the related factors affected the short-term palliative efficacy or not for MOJ after PTBD and PTBS. ResultsAll patients underwent PTBD OR PTBS successfully with the success rate 100%. Twenty seven external drainage tubes (n=16,14.4%),74 internal and external drainage tubes (n=55,49.6%) and 53 bare metal stents (n=40,36.0%) were placed in bile ducts totally. Intraoperative or postoperative hemobilia were found in 3 cases (2.7%). Suppurative cholangitis happened in 32 cases (28.8%) and sepsis in 18 cases (16.2%). Acute pancreatitis, acute renal failure and other critical complications were not found in these cases.(1) Palliative efficacy of one week (paired sample t test):preoperative total bilirubins (TB) were 278.21±153.67 umol/L, and postoperative total bilirubins were reduced to 153.80±114.7umol/L. There is statistically significant difference (P≤0.001) between TB and D7TB. Total bilirubin decreased (42.0±30.5)%, and it was effective in reducing of jaundice in 79 cases (efficient rate 71.2%).Palliative efficacy of one month:47 people were followed up in one month after PTBD and PTBS. Total bilirubin, direct bilirubin and indirect bilirubin decreased about 25%. Total bilirubin decreased to normal in 9 patients, and the success rate of palliation was 19.1%.(2) Preliminary analysis of the factorsThe impact factors of one week palliative efficacy are postoperative one week infection (F= 3.215, P= 0.044), preoperative liver function (t=-1.994, P= 0.049). The impact factors of one month palliative efficacy are the methods of treatment (F=4.021, P=0.025), the time of bile duct obstruction (r=0.422, P=0.003), postoperative one month biliary tract infection (t=-2.269, P=0.028), degree of stenosis (t=3.665, P=0.001), preoperative liver function (t=-3.840, P＜0.001) and preoperative TB (r=0.363, P=0.012).(3) Logistic regression analysis Logistic regression analysis results of one week palliative efficacy:logistic regression model was significant(x2= 4.156, P= 0.041). Fitting equation was fine, Negelkerke R2 was 0.150. Parameter estimates was made:The patients with MOJ which complicated postoperative infection had a worse palliative efficacy (OR= 0.552,95% CI 0.315～0.968). The Palliative effective rate of non-hilar obstruction was 2.653 times as high as of hilar MOJ (OR= 2.653,95% CI 0.988～7.121). Postoperative jaundice reduced faster in the patients with the higher preoperative TB (OR= 1.004,95% CI,1.000～1.007).The logistic regression analysis results of one month Palliative efficacy:logistic regression model was significant (x2= 10.217, P= 0.001). Fitting equation was well, Negelkerke R2 equated to 0.437. Parameter estimation was made:The palliative success rate in the patients with non-hilar obstruction was 13.706 times as high as in the patients with of hilar MOJ (OR= 13.706,95% CI was 2.087～90.030). Stent group (internal drainage) has the highest success rate, while the success rate of external drainage group was the lowest (OR= 4.574,95% CI 0.964～21.704).Conclusions(1) There is a wonderful short-term palliative efficacy for MOJ after PTBD and PTBS. Total bilirubin almost decreased 42% and 75% respectively in one week and one month after PTBD and PTBS. The palliative effective rate in one week after PTBD and PTBS is 71.2%, and the palliative success rate in one month is 19.1%.(2)Postoperative biliary tract infection and sepsis, preoperative liver function C level are risk factors of one week palliative efficacy; These patients with non-hilar MOJ had a better palliative efficacy compared with the patients with hilar MOJ. Palliative efficacy of MOJ with higher postoperative TB shows better.(3) The impact factors of one month palliative success rate after PTBD and PTBS would be obstructive position, the methods of treatment, preoperative liver function, degree of stenosis, preoperative TB, the time of bile duct obstruction and postoperative one month biliary tract infection. The total bilirubin in the patients with non-hilar MOJ Child-Pugh B degree, partial stenosis and treated by stenting are more likely to return to normal level. The total bilirubin in the patients with long-time obstruction, higher preoperative TB and biliary tract infection in one month are hard to return to normal level.(4) Unilateral or bilateral drainage styles, complicated hemobilia after PTBD and PTBS have no significant effect for short-term palliative efficacy after statistical analysis. However, the choice of drainage styles didn't followed the randomized and controlled principle, and the cases of biliary hemorrhage are a few, so further studys are needed.(5) These factors such as:postoperative IB/TB, Bismush type of hilar MOJ, the length of stenosis, degree of bile duct dilatation, the cause of MOJ, the gender and age of these patients with MOJ, have no significant effect for short-term palliative efficacy after PTBD and PTBS.