CompletedNot Applicable

Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

150 participantsStarted 2015-08

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Patients with evidence of distant metastasis or locally advanced tumor * Prior neoadjuvant chemotherapy or Radiotherapy * Prior biliary surgery * Patients with contraindication for major surgery

What they're measuring

Early postoperative mortality (within 3 months)

Timeframe: within 90 days after surgery

Early postoperative morbidities (within 3 months)

Timeframe: within 90 days after surgery

Trial details

NCT IDNCT04289831

SponsorUniversity of Alexandria

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

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