Status:
COMPLETED
Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors
Lead Sponsor:
University of Alexandria
Conditions:
Periampullary Cancer
Biliary Obstruction
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The impact of preoperative biliary drainage (PBD) on morbidity and mortality associated with Pancreaticoduodenectomy (PD) in patients with peri-ampulary tumors is still controversial. The objective of...
Detailed Description
150 consecutive jaundiced patients with suspected operable peri-ampullary tumors were randomized via concealed envelopes into 2 groups (each included 75 patients), group I managed by direct surgery wh...
Eligibility Criteria
Inclusion
- Serum bilirubin level above 4 mg/dl
- suspected peri-ampullary tumor at computed tomography (CT)
- No evidence of distant metastasis or locally advanced tumor
Exclusion
- Patients with evidence of distant metastasis or locally advanced tumor
- Prior neoadjuvant chemotherapy or Radiotherapy
- Prior biliary surgery
- Patients with contraindication for major surgery
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04289831
Start Date
August 1 2015
End Date
October 1 2019
Last Update
February 28 2020
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