Pancreatic Cancer, Periampullary Carcinoma
Conditions
Keywords
Obstructive Jaundice, Preoperative Biliary Drainage, Pancreatoduodenectomy
Brief summary
The purpose of this study is to evaluate the efficacy of preoperative biliary drainage (PBD) which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by observing the prevalence of drainage and surgery related complications, hospital stay, medical cost and life quality compared to surgery alone. It is anticipated that PBD can reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.
Detailed description
Obstructive jaundice is a common symptom in patients with pancreatic head cancer or peri-ampullary cancer. It is regarded that proper surgical resection is the only possible way of radical cure for those patients without evidence of metastasis. Since high preoperative bilirubin level is suggested to be a risk factor for pancreatoduodenectomy, preoperative biliary drainage has been applied to clinical practice to improve the outcome of surgery. However, results from previous studies have inconsistent results showing that PBD may have adverse effect on patients by elevating the prevalence of complications. Since PBD is widely performed worldwide, its value needs to be clarified. Thus the present study is designed to systematically evaluate the value of PBD via recruiting participants who may most likely benefit from PBD. It is anticipated that results from this study can present an instructive conclusion on whether PBD should be performed prior to pancreatoduodenectomy as well as reveal the preferable type of PBD.
Interventions
PROCEDUREPancreatoduodenectomy
PROCEDUREENBD and Pancreatoduodenectomy
PROCEDUREEBD and Pancreatoduodenectomy
PROCEDUREPTCD and Pancreatoduodenectomy
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 70 years old * CT (Computed Tomography), CTA (Computed Tomographic Angiography), MRI (Magnetic Resonance Imaging) or ultrasonic test suggested pancreatic head carcinoma or periampullary carcinoma with obstructive jaundice * First routine test of serum bilirubin above 250μmol per liter
Exclusion criteria
* Distant metastasis in liver, lung or other sites * Invasion of local blood vessels (e.g. aorta, portal vein, postcava) * Poor physical condition, unable to tolerate anesthesia and surgery (e.g. severe cardio-pulmonary diseases, blood coagulation disorders) * With cholangitis, active hepatitis or other diseases which should be excluded from study according to the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Infectious Complications | up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Bile Leakage | up to 6 months |
| Incidence of Pancreatic Leakage | up to 6 months |
| Life Quality Score | up to 12 months |
| Digestive Function Recovery | up to 6 months |
| Incidence of Hemorrhagic Complications | up to 6 months |
| Liver Function Evaluation | up to 6 months |
Other
| Measure | Time frame |
|---|---|
| Incidence of Pleural Effusion | up to 6 months |
| Incidence of Incision Complications | up to 3 months |
| Incidence of Pulmonary Infections | up to 6 months |
Countries
China
Contacts
Primary ContactHuai-zhi Wang, M.D., Ph.D.
Outcome results
None listed