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Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent

ConditionsPancreaticoduodenectomyAntibiotherapy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

The main objective of the study is to compare 2 broad-spectrum antibiotic (Piperacillin / Tazobactam) treatment modalities, following pancreaticoduodenectomy in patients with preoperative biliary stent, to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Planned pancreaticoduodenectomy for periampullary neoplasms

Endoscopic or radiological pre-operative biliary drainage

Age ≥ 18 years old

Patient able to comply with the study protocol, in the investigator's judgment

Disqualifiers

Contraindication to PIPERACILLIN/TAZOBACTAM PANPHARMA 4g / 500mg powder for solution for injection in accordance with its SmPC

Patients allergic to beta-lactam antibiotics

Others pancreatic resection

Absence of preoperative biliary drainage

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antibioprophylaxis (Piperacillin-tazobactam)

    Drug

    antibiotic prophylaxis during surgery

  • 5 days Antibiotherapy (Piperacillin-tazobactam)

    Drug

    5 days Antibiotherapy from surgery

Treatment groups

326 Participants
are divided into 2 treatment groups
Group A: Broad spectrum antibioprophylaxisActive comparator 1 intervention
Group B: Broad spectrum antibiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

presence of an organ/space SSI

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

Time frame
90 days after the surgery

Secondary outcomes

1

Infectious complications at post-operative

Overall postsurgical morbidity, graded according to the Dindo/Clavien classification and CCI score

Time frame
day 90
2

Correlation between post-operative bacteriological samples and intraoperative bile samples

Correlation between post-operative bacteriological samples and intraoperative bile samples (presence of bacterial strains)

Time frame
day 90
3

Bacteriological resistance profiles

Incidence of fungal contamination

Time frame
day 90
4

Correlation between bacteriological and fungal contaminations

Correlation between bacteriological and fungal contaminations (presence of bacterial strains and fungal contamination)

Time frame
day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: