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


Phase 3
18 Years
65 Years
Open (Enrolling by invite only)
Both
Postoperative Complications

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the difference in postoperative morbidity

Outcome Description:

the difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage))

Outcome Time Frame:

12 weeks postoperation

Safety Issue:

No

Principal Investigator

Song Tian qiang, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tianjin Medical University Cancer Institute and Hospital

Authority:

China: Ethics Committee

Study ID:

CIH-STQ-201205001

NCT ID:

NCT01744938

Start Date:

September 2012

Completion Date:

December 2015

Related Keywords:

  • Postoperative Complications
  • Postoperative Complications,
  • mortality,
  • length of Stay,
  • economics
  • Jaundice
  • Jaundice, Obstructive
  • Postoperative Complications

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