---
title: "Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary"
nct_id: NCT05011630
overall_status: COMPLETED
sponsor: National Taiwan University Hospital
study_type: OBSERVATIONAL
primary_condition: Intraabdominal Abscess After Procedure
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05011630.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05011630"
ct_last_update_post_date: 2021-08-18
last_seen_at: "2026-05-12T07:17:27.213Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Specific Bile Microorganisms Caused Intra-abdominal Abscess on Pancreaticoduodenectomy Patients: Customized Antibiotics And Antifungal Medication May Be Necessary

**NCT ID:** [NCT05011630](https://clinicaltrials.gov/study/NCT05011630)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 539
- **Lead Sponsor:** National Taiwan University Hospital
- **Conditions:** Intraabdominal Abscess After Procedure
- **Start Date:** 2007-01-01
- **Completion Date:** 2021-06-30
- **CT.gov Last Update:** 2021-08-18

## Brief 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.

## Eligibility

- **Minimum age:** 20 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* all pancreaticoduodenectomy patients

Exclusion Criteria:

* no bile cultures
```

## Arms

- **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.
- **Non-IAA group** — No IAA formation

## Interventions

- **Pancreaticoduodenectomy** (OTHER) — The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA

## Primary Outcomes

- **Intraabdominal abscess** _(time frame: 1 month after surgery)_ — The abscess formation after surgery

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05011630.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05011630*  
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