Trial Outcomes & Findings for Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers (NCT NCT01134276)

Results Overview

at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

211 participants

Primary outcome timeframe

within 120 days after drainage

Results posted on

2014-06-11

Participant Flow

Total 211 patients underwent pancreatoduodenectomy after preoperative biliary drainage at Seoul National University Hospital.

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

Participant milestones

Participant milestones
Measure	ERBD biliary drainage : biliary drainage via ERBD/ENBD	PTBD biliary drainage : biliary drainage via PTBD
Overall Study STARTED	104	107
Overall Study COMPLETED	104	107
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ERBD n=104 Participants final biliary drainage procedure: biliary drainage via ERBD/ENBD	PTBD n=107 Participants final biliary drainage procedure : biliary drainage via PTBD	Total n=211 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 8.6 • n=5 Participants	63.5 years STANDARD_DEVIATION 9.0 • n=7 Participants	64.8 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	42 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	65 Participants n=7 Participants	136 Participants n=5 Participants
Region of Enrollment Korea, Republic of	104 participants n=5 Participants	107 participants n=7 Participants	211 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	PTBD n=107 Participants finial biliary drainage procedure: biliary drainage via PTBD	ERBD n=104 Participants finial biliary drainage procedure: biliary drainage via ERBD or ENBD
Incidence of Infectious Complications After Biliary Drainage	11 participants	5 participants

SECONDARY outcome

Timeframe: within 14 days after drainage

Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)

Outcome measures

Outcome measures
Measure	PTBD n=107 Participants finial biliary drainage procedure: biliary drainage via PTBD	ERBD n=104 Participants finial biliary drainage procedure: biliary drainage via ERBD or ENBD
Change in Total Serum Bilirubin After Drainage	0.7 mg/dL/day Standard Deviation 0.5	0.6 mg/dL/day Standard Deviation 0.4

SECONDARY outcome

Timeframe: during hospital stay for biliary drainage procedure

Total hospital cost during admission after Biliary Drainage in US dollars

Outcome measures

Outcome measures
Measure	PTBD n=107 Participants finial biliary drainage procedure: biliary drainage via PTBD	ERBD n=104 Participants finial biliary drainage procedure: biliary drainage via ERBD or ENBD
Total Hospital Cost During Admission After Biliary Drainage	16.0 thousands in US dollars Standard Deviation 5.9	17.0 thousands in US dollars Standard Deviation 7.5

Adverse Events

PTBD

Serious events: 29 serious events

Other events: 0 other events

Deaths: 0 deaths

ERBD

Serious events: 23 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PTBD n=107 participants at risk final biliary drainage procedure: biliary drainage via PTBD Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting	ERBD n=104 participants at risk final biliary drainage procedure: biliary drainage via ERBD/ENBD Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting
Blood and lymphatic system disorders Bleeding	5.6% 6/107 • Number of events 6 • 7 days after procedure such as PTBD and ENBD/ERBD per Intervention	2.9% 3/104 • Number of events 3 • 7 days after procedure such as PTBD and ENBD/ERBD per Intervention
Gastrointestinal disorders Pancreatitis	2.8% 3/107 • Number of events 3 • 7 days after procedure such as PTBD and ENBD/ERBD per Intervention	16.3% 17/104 • Number of events 17 • 7 days after procedure such as PTBD and ENBD/ERBD per Intervention
Gastrointestinal disorders Cholangitis	8.4% 9/107 • Number of events 9 • 7 days after procedure such as PTBD and ENBD/ERBD per Intervention	4.8% 5/104 • Number of events 5 • 7 days after procedure such as PTBD and ENBD/ERBD per Intervention
Surgical and medical procedures tube malfunction	8.4% 9/107 • Number of events 9 • 7 days after procedure such as PTBD and ENBD/ERBD per Intervention	6.7% 7/104 • Number of events 7 • 7 days after procedure such as PTBD and ENBD/ERBD per Intervention
Gastrointestinal disorders Bile peritonitis	1.9% 2/107 • Number of events 2 • 7 days after procedure such as PTBD and ENBD/ERBD per Intervention	0.00% 0/104 • 7 days after procedure such as PTBD and ENBD/ERBD per Intervention

Other adverse events

Adverse event data not reported

Additional Information

Sun-Whe Kim

Seoul National University College of Medicine

Phone: +82-2-2072-2315

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place