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CompletedNCT05011630Updated Aug 18, 2021

Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary

An observational study in Intraabdominal Abscess After Procedure, sponsored by National Taiwan University Hospital. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
539
Ages
20 Years and older
Sex
All
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Study summary

Background Intra-abdominal abscess (IAA) is one of the most serious surgical infectious complications on pancreaticoduodenectomy (PD) patients. Preoperative biliary drainage (PBD) is considered as a risk of surgical infectious complications. However, the reason why PBD caused IAA was unknown. In this study, we hypothesize that bile contamination may increase the rate of IAA as bile from residual common bile duct (CBD) leaks and contaminates the abdominal cavity.

Methods We retrospectively collected PD patients with performance of bile culture between 2007 and 2019 in our institute. As to bile culture, we used a swab to do intraoperative bile cultures after transection of the CBD. IAA was defined as a postoperative fluid collection managed by CT-guided placement of drains with documental bacteriological culture.

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Conditions studied

  • Intraabdominal Abscess After Procedure

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Keywords

  • pancreaticoduodenectomy, biliary drainage, positive bile culture, intra-abdominal abscess, surgical complication
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In context

Abdominal Abscess

31 studies on the registry are indexed under Abdominal Abscess; 5 are open to participants now.

Browse Abdominal Abscess studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Surgical populations

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all pancreaticoduodenectomy patients

Exclusion criteria

Exclusion Criteria:

  • no bile cultures
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
539 participants (actual)
Patient registry
No

Groups and cohorts

  • IAA group

    Intraabdominal abscess (IAA) is defined as either a turbid discharge from the intraoperatively placed drain or a postoperative fluid collection managed by CT-guided placement of drains with documental bacteriological culture.

    Other: Pancreaticoduodenectomy

  • Non-IAA group

    No IAA formation

    Other: Pancreaticoduodenectomy

Interventions

  • OtherPancreaticoduodenectomy

    The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA

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What researchers measure

Primary outcomes

  1. Intraabdominal abscess

    The abscess formation after surgery

    Time frame: 1 month after surgery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2007 to primary completion in Dec 2019, 155 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2021
First posted
Aug 18, 2021
StartActual
Jan 1, 2007
Primary completionActual
Dec 31, 2019
CompletionActual
Jun 30, 2021
Last update
Aug 18, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05011630
Responsible party
Sponsor
First posted
Aug 18, 2021
Start date
Jan 1, 2007
Primary completion
Dec 31, 2019
Completion
Jun 30, 2021
Last update
Aug 18, 2021

Study contacts

Jin-Ming Wu, MD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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