Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01744938
First received: December 5, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted

December 5, 2012
December 5, 2012
September 2012
September 2015   (final data collection date for primary outcome measure)
the difference in postoperative morbidity [ Time Frame: 12 weeks postoperation ] [ Designated as safety issue: No ]
the difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage))
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Postoperative Complications
Procedure: preoperative biliary drainage
percutaneous preoperative biliary drainage guided by CT
  • No Intervention: early surgery
    only receiving pancreaticoduodenectomy without preoperative biliary drainage
  • Experimental: preoperative biliary drainage
    percutaneous preoperative biliary drainage before pancreaticoduodenectomy guided by CT scan
    Intervention: Procedure: preoperative biliary drainage

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
136
December 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01744938
CIH-STQ-201205001
Yes
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
Not Provided
Principal Investigator: Song Tian qiang, doctor Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP