Spots Global Cancer Trial Database for Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

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Trial Identification

Brief Title: Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

Official Title: "Impact of Preoperative Biliary Drainage on Surgical and Oncologic Outcomes After Pancreatico-Duodenectomy in Patients With Operable Malignant Periampulary Tumors. A Randomized Controlled Study"

Study ID: NCT04289831

Conditions

Periampullary Cancer

Biliary Obstruction

Preoperative Biliary Drainage

Interventions

Preoperative Biliary Drainage (PBD)

Surgery

Study Description

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

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 while group II managed by PBD followed by surgery. Both groups were compared regarding perioperative mortality, morbidities, tumor recurrence and 2 years survival rates.