Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy

Army Medical University

Status and phase: Unknown; Phase 2

Conditions: Periampullary Carcinoma; Pancreatic Cancer

Treatments: Procedure: PTCD and Pancreatoduodenectomy; Procedure: EBD and Pancreatoduodenectomy; Procedure: ENBD and Pancreatoduodenectomy; Procedure: Pancreatoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01941342

NDR-2014-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 274 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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274 participants in 4 patient groups

Pancreatoduodenectomy

Active Comparator group

Description:

Instant pancreatoduodenectomy within one week after diagnosis including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract.

Treatment:

Procedure: Pancreatoduodenectomy

ENBD and Pancreatoduodenectomy

Experimental group

Description:

Consistent ENBD (Endoscopic Nasobiliary Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract.

Treatment:

Procedure: ENBD and Pancreatoduodenectomy

EBD and Pancreatoduodenectomy

Experimental group

Description:

Consistent EBD (Endoscopic Biliary Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract.

Treatment:

Procedure: EBD and Pancreatoduodenectomy

PTCD and Pancreatoduodenectomy

Experimental group

Description:

Consistent PTCD (Percutaneous Transhepatic Cholangial Drainage) for 3 weeks or drainage until bilirubin level decreases to 200μmol per liter or below then perform pancreatoduodenectomy including: Evaluate the resectability; Remove pancreas head, gastric pyloric antrum, duodenum, distal common bile duct and regional lymph nodes; Reconstruct digestive tract.

Treatment:

Procedure: PTCD and Pancreatoduodenectomy