Clinical trial NCT01941342: Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy
Official title: Evaluation of Preoperative Biliary Drainage on Outcome of Pancreatoduodenectomy: A Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Periampullary Carcinoma
Keywords: Obstructive Jaundice
Preoperative Biliary Drainage
Pancreatoduodenectomy
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Infectious Complications
timeFrame: up to 12 months
Secondary outcomes:
measure: Incidence of Hemorrhagic Complications
timeFrame: up to 6 months
measure: Liver Function Evaluation
timeFrame: up to 6 months
measure: Incidence of Bile Leakage
timeFrame: up to 6 months
measure: Incidence of Pancreatic Leakage
timeFrame: up to 6 months
measure: Life Quality Score
timeFrame: up to 12 months
measure: Digestive Function Recovery
timeFrame: up to 6 months
Other outcomes:
measure: Incidence of Incision Complications
timeFrame: up to 3 months
measure: Incidence of Pulmonary Infections
timeFrame: up to 6 months
measure: Incidence of Pleural Effusion
timeFrame: up to 6 months
Locations:
city: Chongqing
country: China
facility: Institution of Hepatobiliary Surgery, Southwest Hospital
state: Chongqing
Study officials:
affiliation: Southwest Hospital, China
name: Huai-zhi Wang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: