Trial Outcomes & Findings for Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy (NCT NCT00679952)

Results Overview

pancreatic fistula rate is stratified according to ISGPF criteria. Grade A; No major impact Grade B; Clinically relevant fistula, specific treatment may be required Grade C; Most severe form of fistula, with a high mortality rate

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

168 participants

Primary outcome timeframe

postoperative 1 week

Results posted on

2014-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Closed Suction Drainage Group closed suction drainage group (CD group)	Natural Drainage Group natural drainage group (ND group)
Overall Study STARTED	86	82
Overall Study COMPLETED	86	82
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Closed Suction Drainage Group n=86 Participants closed suction drainage group (CD group)	Natural Drainage Group n=82 Participants natural drainage group (ND group)	Total n=168 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=93 Participants	49 Participants n=4 Participants	108 Participants n=27 Participants
Age, Categorical >=65 years	27 Participants n=93 Participants	33 Participants n=4 Participants	60 Participants n=27 Participants
Age, Continuous	60.7 years STANDARD_DEVIATION 10.1 • n=93 Participants	61.4 years STANDARD_DEVIATION 11.1 • n=4 Participants	61.2 years STANDARD_DEVIATION 10.6 • n=27 Participants
Sex: Female, Male Female	37 Participants n=93 Participants	27 Participants n=4 Participants	64 Participants n=27 Participants
Sex: Female, Male Male	49 Participants n=93 Participants	55 Participants n=4 Participants	104 Participants n=27 Participants
Region of Enrollment Korea, Republic of	86 participants n=93 Participants	82 participants n=4 Participants	168 participants n=27 Participants

PRIMARY outcome

Timeframe: postoperative 1 week

pancreatic fistula rate is stratified according to ISGPF criteria. Grade A; No major impact Grade B; Clinically relevant fistula, specific treatment may be required Grade C; Most severe form of fistula, with a high mortality rate

Outcome measures

Outcome measures
Measure	Closed Suction Drainage Group n=86 Participants closed suction drainage group (CD group)	Natural Drainage Group n=82 Participants natural drainage group (ND group)
Number of Patients With Pancreatic Fistula	9 participants	8 participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

Adverse Events

Closed Suction Drainage Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Natural Drainage Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical instructor

Seoul National University College of Medicine

Phone: 82-2-2072-2817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place