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Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

NCT04289831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-02-28

No results posted yet for this study

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 this study is to evaluate the impact of PBD on surgical and oncologic outcomes after PD in jaundiced patients with operable peri-ampulary tumors.

Conditions

  • Periampullary Cancer
  • Biliary Obstruction
  • Preoperative Biliary Drainage

Interventions

PROCEDURE

Preoperative Biliary Drainage (PBD)

Endoscopic retrograde biliary drainage (ERBD) and stent placement was the first choice for PBD while ultrasound-guided percutaneous transhepatic biliary drainage (PTBD) was done if ERBD was not feasible. Biliary drainage was considered successful if the serum bilirubin level decreased by 50% or more within 2 weeks after the procedure. Patients with failed PBD were referred directly to surgery, while those with successful PBD were referred to surgery 4 to 6 weeks after first drainage procedure according to the latest guidelines

PROCEDURE

Surgery

The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy

Sponsors & Collaborators

  • University of Alexandria

    lead OTHER

Principal Investigators

  • Mohamed M Elmessiry, MD,PhD · Ass. Professor of Surgery (Surgical Oncology Unit)

  • Eman A Mohamed, MD, PhD · Lecturer of Internal Medicine (Gastroenterology Unit)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-10-31
Completion
2019-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04289831 on ClinicalTrials.gov