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Postoperative anti-infective strategy following pancreaticoduodenectomy in patients with preoperative biliary stent FRENCH24 ANIS

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515181-14-00
Acronym
2020/0423/HP
Enrollment
326
Registered
2024-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with preoperative biliary stent treated by pancreaticoduodenectomy

Brief summary

The primary endpoint is the presence of organ/space SSI determined according to the Centers for Disease Control and Prevention’s national nosocomial infections surveillance system. Organ/space SSIs included postoperative pancreatic fistula (POPF) and bile leakage, with positive culture results.

Detailed description

Infectious complications at post-operative day 90 Overall postsurgical morbidity, graded according to the Dindo/Clavien classification and CCI score at post operative day 90 Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria Readmission rates at post-operative day 90 Duration of hospitalization, Correlation between post-operative bacteriological samples and intraoperative bile samples, Bacteriological resistance profiles, Incidence of fungal contamination, Correlation between bacteriological and fungal contaminations, Incremental cost per infectious complications avoided

Interventions

DRUGPIPERACILLINE/TAZOBACTAM KABI 4 g/ 500 mg
DRUGpoudre pour solution pour perfusion.

Sponsors

Centre Hospitalier Universitaire Rouen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the presence of organ/space SSI determined according to the Centers for Disease Control and Prevention’s national nosocomial infections surveillance system. Organ/space SSIs included postoperative pancreatic fistula (POPF) and bile leakage, with positive culture results.

Secondary

MeasureTime frame
Infectious complications at post-operative day 90 Overall postsurgical morbidity, graded according to the Dindo/Clavien classification and CCI score at post operative day 90 Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria Readmission rates at post-operative day 90 Duration of hospitalization, Correlation between post-operative bacteriological samples and intraoperative bile samples, Bacteriological resistance profiles, Incidence of fungal contamination, Correlation between bacteriological and fungal contaminations, Incremental cost per infectious complications avoided

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026