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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.

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01744938
Enrollment
136
Registered
2012-12-07
Start date
2012-09-30
Completion date
2016-12-31
Last updated
2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

Postoperative Complications,, mortality,, length of Stay,, economics

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.

Interventions

percutaneous preoperative biliary drainage guided by CT

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the difference in postoperative morbidity12 weeks postoperationthe difference in postoperative morbidity between two groups (preoperative biliary drainage or early surgery (without preoperative biliary drainage))

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026