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Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice

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ClinicalTrials.gov Identifier: NCT01744938
Recruitment Status : Unknown
Verified May 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : December 7, 2012
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Tracking Information
First Submitted Date  ICMJE December 5, 2012
First Posted Date  ICMJE December 7, 2012
Last Update Posted Date December 22, 2015
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
the difference in postoperative morbidity [ Time Frame: 12 weeks postoperation ]
the difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage))
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice
Official Title  ICMJE Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice: A Phase III, Randomized, Controlled, Single Center Study.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Complications
Intervention  ICMJE Procedure: preoperative biliary drainage
percutaneous preoperative biliary drainage guided by CT
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 5, 2012)
136
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01744938
Other Study ID Numbers  ICMJE CIH-STQ-201205001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tianjin Medical University Cancer Institute and Hospital
Study Sponsor  ICMJE Tianjin Medical University Cancer Institute and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Song Tian qiang, doctor Tianjin Medical University Cancer Institute and Hospital
PRS Account Tianjin Medical University Cancer Institute and Hospital
Verification Date May 2012

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