Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

Tianjin Medical University

Status and phase: Unknown; Phase 3

Conditions: Postoperative Complications

Treatments: Procedure: preoperative biliary drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT01744938

CIH-STQ-201205001

Details and patient eligibility

About

Patients with the lower malignant obstructive jaundice planned to do the pancreaticoduodenectomy, receiving preoperative biliary drainage or early surgery (without preoperative biliary drainage), both groups has the similar surgical morbidity, no statistics significance.

Full description

Patients with the lower malignant obstructive jaundice divided into two groups:early surgery, preoperative biliary drainage + surgery.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with the lower malignant obstructive jaundice
• Total bilirubin: 150-350 umol/L

Exclusion criteria

• age less than 18
• emergency operation
• biliary tract stent placed
• past history of operation on pancreas
• intraoperative unresectable tumor with pancreaticoduodenectomy
• unresectable tumor or potential resectable tumor with pancreaticoduodenectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

early surgery

No Intervention group

Description:

only receiving pancreaticoduodenectomy without preoperative biliary drainage

preoperative biliary drainage

Experimental group

Description:

percutaneous preoperative biliary drainage before pancreaticoduodenectomy guided by CT scan

Treatment:

Procedure: preoperative biliary drainage