Ampulla of Vater Cancer, Bile Duct Cancer, Pancreas Head Cancer, Periampullary Cancers With Obstructive Jaundice
Conditions
Brief summary
Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.
Interventions
PROCEDUREbiliary drainage
biliary drainage via PTBD or ERBD/ENBD
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patient who have periampullary tumors causing obstructive jaundice * patient age: ≥20 and ≤85 * resectable state of disease * no history of previous chemotherapy or radiotherapy * patients without uncontrollable severe cardiovascular, respiratory disease * Karnofsky performance scale ≥70 * informed consent
Exclusion criteria
* patients with distant metastasis or locally advanced disease with major vascular invasion * duodenal cancer * biliary drainage before randomization * previous chemotherapy or radiotherapy * uncontrollable active infection except cholangitis * severe comorbid disease (cardiac, pulmonary, cerebrovascular)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Infectious Complications After Biliary Drainage | within 120 days after drainage | at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Serum Bilirubin After Drainage | within 14 days after drainage | Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day) |
| Total Hospital Cost During Admission After Biliary Drainage | during hospital stay for biliary drainage procedure | Total hospital cost during admission after Biliary Drainage in US dollars |
Countries
South Korea
Participant flow
Recruitment details
Total 211 patients underwent pancreatoduodenectomy after preoperative biliary drainage at Seoul National University Hospital.
Pre-assignment details
144 patients and 68 patients were intended to be treated with ERBD/ENBD and PTBD, respectively. Among 144 patients, 39 patients were switched to PTBD due to a procedure failure. Finally, 104 and 107 patients were treated with ERBD/ENBD and PTBD, respectively. Clinical outcomes were compared on the basis on the final drainage method
Participants by arm
| Arm | Count |
|---|---|
| ERBD final biliary drainage procedure: biliary drainage via ERBD/ENBD | 104 |
| PTBD final biliary drainage procedure : biliary drainage via PTBD | 107 |
| Total | 211 |
Baseline characteristics
| Characteristic | ERBD | PTBD | Total |
|---|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 8.6 | 63.5 years STANDARD_DEVIATION 9 | 64.8 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment Korea, Republic of | 104 participants | 107 participants | 211 participants |
| Sex: Female, Male Female | 33 Participants | 42 Participants | 75 Participants |
| Sex: Female, Male Male | 71 Participants | 65 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 107 | 0 / 104 |
| serious Total, serious adverse events | 29 / 107 | 23 / 104 |
Outcome results
Primary
Incidence of Infectious Complications After Biliary Drainage
at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
Time frame: within 120 days after drainage
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PTBD | Incidence of Infectious Complications After Biliary Drainage | 11 participants |
| ERBD | Incidence of Infectious Complications After Biliary Drainage | 5 participants |
Secondary
Change in Total Serum Bilirubin After Drainage
Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)
Time frame: within 14 days after drainage
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTBD | Change in Total Serum Bilirubin After Drainage | 0.7 mg/dL/day | Standard Deviation 0.5 |
| ERBD | Change in Total Serum Bilirubin After Drainage | 0.6 mg/dL/day | Standard Deviation 0.4 |
Secondary
Total Hospital Cost During Admission After Biliary Drainage
Total hospital cost during admission after Biliary Drainage in US dollars
Time frame: during hospital stay for biliary drainage procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTBD | Total Hospital Cost During Admission After Biliary Drainage | 16.0 thousands in US dollars | Standard Deviation 5.9 |
| ERBD | Total Hospital Cost During Admission After Biliary Drainage | 17.0 thousands in US dollars | Standard Deviation 7.5 |