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
  Purpose

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 Intervention Phase
Postoperative Complications
Procedure: preoperative biliary drainage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice: A Phase III, Randomized, Controlled, Single Center Study.

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • 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))


Estimated Enrollment: 136
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01744938     History of Changes
Other Study ID Numbers: CIH-STQ-201205001
Study First Received: December 5, 2012
Last Updated: December 5, 2012
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 25, 2014