Jaundice, Obstructive, Klatskin Tumor
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including PTBD (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS (Endoscopic Biliary Stenting).
Interventions
PROCEDUREPTBD group
Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
PROCEDUREENBD group
Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
PROCEDUREEBS group
Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who meet the following four criteria are included into the study: 1. Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery; 2. Serum total bilirubin is higher than 51 umol/l; 3. Age is older than 18 and younger than 80 years old; 4. Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD.
Exclusion criteria
* If any of the following items are met, the subject cannot enter the study. 1. Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery; 2. Malignant obstructive jaundice caused by metastatic tumors; 3. Pregnancy or lactation women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate after drainage | From PBD to completion of radical surgery, an average of 1 month | Complication rate between PBD (preoperative biliary drainage) and radical surgery |
| Complication rate after radical surgery | 1 month post operatively | Complication rate after radical surgery |
| Success rate of PBD | Day 1 | Success rate of different methods of PBD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| implantation metastasis | Day 1 | Rate of implantation metastasis |
| Rate of change in Total bilirubin | 2 weeks after PBD | Recovery efficiency of liver function |
| operative time | Day 1 | duration of radical surgery |
| Rate of change in aspartate aminotransferase | 2 weeks after PBD | Recovery efficiency of liver function |
| Rate of change in alanine aminotransferase | 2 weeks after PBD | Recovery efficiency of liver function |
| Hepatoduodenal edema | at time of radical surgery | Degree of hepatoduodenal edema (including no edema, mild edema, moderate edema, and severe edema) |
| Perioperative mortality | from PBD to 4 weeks after surgery, an average of 2 month | Mortality between PBD and 4 weeks after surgery |
Contacts
Primary ContactHoubao Liu, PHD
Outcome results
None listed