Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice: A Phase III, Randomized, Controlled, Single Center Study.

Sponsors

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Source 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.

Overall Status Unknown status
Start Date September 2012
Completion Date December 2016
Primary Completion Date November 2016
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
the difference in postoperative morbidity 12 weeks postoperation
Enrollment 136
Condition
Intervention

Intervention Type: Procedure

Intervention Name: preoperative biliary drainage

Description: percutaneous preoperative biliary drainage guided by CT

Arm Group Label: preoperative biliary drainage

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Song Tian qiang, doctor Principal Investigator Tianjin Medical University Cancer Institute and Hospital
Verification Date

May 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: early surgery

Type: No Intervention

Description: only receiving pancreaticoduodenectomy without preoperative biliary drainage

Label: preoperative biliary drainage

Type: Experimental

Description: percutaneous preoperative biliary drainage before pancreaticoduodenectomy guided by CT scan

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov