Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

Not Applicable

Completed

• Conditions: Biliary Obstruction; Preoperative Biliary Drainage; Periampullary Cancer
• Interventions: Procedure: Surgery; Procedure: Preoperative Biliary Drainage (PBD)

• Registration Number: NCT04289831
• Lead Sponsor: University of Alexandria

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.

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2017-10
• Study Completion: 2019-10
• Status Verified: 2020-02
• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Study First Posted: 2020-02-28
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Surgery (DS) group	Surgery	patients subjected to direct surgery (DS) within 1 week after randomization
Preoperative Biliary Drainage (PBD) group	Preoperative Biliary Drainage (PBD)	patients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks.
Preoperative Biliary Drainage (PBD) group	Surgery	patients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks.

Primary Outcome Measures

Name	Time	Method
Early postoperative mortality (within 3 months)	within 90 days after surgery	Death within 90 days postoperatively
Early postoperative morbidities (within 3 months)	within 90 days after surgery	Any complications related to surgery within 3 months including: postoperative bleeding, pancreatic fistula, Biliary leakage, Intra-abdominal infection, wound infection/ dehiscence

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years follow up after surgery	% of patients survived with or without tumor recurrence after 2 years follow up
Tumor recurrence	2 years follow up after surgery	Local or systemic recurrence of the malignant tumor
Disease free survival (DFS)	2 years follow up after surgery	% of patients survived without any evidence of tumor recurrence after 2 years follow up