Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

Phase 3

• Conditions: Postoperative Complications
• Interventions: Procedure: preoperative biliary drainage

• Registration Number: NCT01744938
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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.

Detailed Description

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

Study Timeline

• Status Verified: 2012-05
• Study Start: 2012-09
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-07
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preoperative biliary drainage	preoperative biliary drainage	percutaneous preoperative biliary drainage before pancreaticoduodenectomy guided by CT scan

Primary Outcome Measures

Name	Time	Method
the difference in postoperative morbidity	12 weeks postoperation	the difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage))