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

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.

Study Overview

• Status: Completed
• Conditions: Intraabdominal Abscess After Procedure
• Intervention / Treatment: Other: Pancreaticoduodenectomy

• Study Type: Observational
• Enrollment (Actual): 539

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Surgical populations

Description

Inclusion Criteria:

• all pancreaticoduodenectomy patients

Exclusion Criteria:

• no bile cultures

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA
Non-IAA group; No IAA formation	Other: Pancreaticoduodenectomy; The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraabdominal abscess	The abscess formation after surgery	1 month after surgery

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Jin-Ming Wu, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: August 15, 2021
• First Submitted That Met QC Criteria: August 15, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 15, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pancreaticoduodenectomy, biliary drainage, positive bile culture, intra-abdominal abscess, surgical complication
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess; Abdominal Abscess
• Other Study ID Numbers: 201803035RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No