Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periampullary Cancer, Biliary Obstruction, Preoperative Biliary Drainage

Intervention / Treatment
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* Procedure: Preoperative Biliary Drainage (PBD)
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct Surgery (DS) group<br>patients subjected to direct surgery (DS) within 1 week after randomization | Procedure: Surgery<br>* The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy<br>|
| Active Comparator: Preoperative Biliary Drainage (PBD) group<br>patients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks. | Procedure: Preoperative Biliary Drainage (PBD)<br>* 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<br>Procedure: Surgery<br>* The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor recurrence | Local or systemic recurrence of the malignant tumor | 2 years follow up after surgery | 
| Disease free survival (DFS) | % of patients survived without any evidence of tumor recurrence after 2 years follow up | 2 years follow up after surgery | 
| Overall survival (OS) | % of patients survived with or without tumor recurrence after 2 years follow up | 2 years follow up after surgery |