Biliary Obstruction, Periampullary Cancer, Preoperative Biliary Drainage
Conditions
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.
Interventions
PROCEDUREPreoperative Biliary Drainage (PBD)
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
PROCEDURESurgery
The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy
Sponsors
University of Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Overall survival (OS) | 2 years follow up after surgery | % of patients survived with or without tumor recurrence after 2 years follow up |
Outcome results
None listed