Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

University of Alexandria

Status: Completed

Conditions: Periampullary Cancer; Biliary Obstruction; Preoperative Biliary Drainage

Treatments: Procedure: Surgery; Procedure: Preoperative Biliary Drainage (PBD)

Study type: Interventional

Funder types: Other

Identifiers

NCT04289831

03027612

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Direct Surgery (DS) group

Active Comparator group

Description:

patients subjected to direct surgery (DS) within 1 week after randomization

Treatment:

Procedure: Surgery

Preoperative Biliary Drainage (PBD) group

Active Comparator group

Description:

patients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks.

Treatment:

Procedure: Preoperative Biliary Drainage (PBD)

Procedure: Surgery