Clinical trial · Observational
Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies
NCT03525067CI-TRIAL-00032923completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality for patients who underwent pancreaticoduodenectomy. The hypothesis is that a proportion of post-operative infections after pancreaticoduodenectomy is due to bacteria that colonize the bile ducts during the preoperative period.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Bile Duct; Obliteration | — | UNRESOLVED | — |
| Delayed Gastric Emptying | — | UNRESOLVED | — |
| Duodenal Cancer | Malignant Duodenal Neoplasm | ALIAS | 0.90 |
| Fistula | — | UNRESOLVED | — |
| Fistula, Biliary | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Post-Op Complication | — | UNRESOLVED | — |
| Post-Op Infection | — | UNRESOLVED | — |
| Sepsis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bile sampling for bacterial examination | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with Bile Samples
- description
- Patients underwent pancreaticoduodenectomy who had intraoperative bile sampling for bacterial examination.
- interventionNames
- Other: Bile sampling for bacterial examination
Primary outcomes (1)
- measure
- Postoperative infectious complications at postoperative day 90
- timeFrame
- Postoperative time until day 90
- description
- Patients with postoperative infectious complications and compare bacteriological results of samples with bile samples.
Secondary outcomes (3)
- measure
- Mortality before ICU discharge
- timeFrame
- 90 days
- description
- Mortality rate before ICU discharge
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients over the age of 18 * patients underwent programmed pancreaticoduodenectomy Exclusion Criteria: * Patients underwent emergency pancreaticoduodenectomy (delay less than 48 hours) * Patients had not been taken of a biliary sample in intraoperative period
References
Publications (0)
Data not yet available
No reference posted for this study.