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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

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.

Condition or disease Intervention/treatment Phase
Postoperative Complications Procedure: preoperative biliary drainage Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice: A Phase III, Randomized, Controlled, Single Center Study.
Study Start Date : September 2012
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
U.S. FDA Resources

Arm Intervention/treatment
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
Procedure: preoperative biliary drainage
percutaneous preoperative biliary drainage guided by CT



Primary Outcome Measures :
  1. 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))



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744938


Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Principal Investigator: Song Tian qiang, doctor Tianjin Medical University Cancer Institute and Hospital

Additional Information:
Publications of Results:

Other Publications:
Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01744938     History of Changes
Other Study ID Numbers: CIH-STQ-201205001
First Posted: December 7, 2012    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: May 2012

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Postoperative Complications,
mortality,
length of Stay,
economics

Additional relevant MeSH terms:
Postoperative Complications
Jaundice
Jaundice, Obstructive
Pathologic Processes
Hyperbilirubinemia
Skin Manifestations
Signs and Symptoms