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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006991-18 | EudraCT Number |
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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)
Despite cumulative efforts in surgery and perioperative management, the morbi-mortality rates of pancreatoduodenectomy (PD) remain high. The most frequent complications were sepsis and infectious complications 44%, hemorrhagic complications 36.6%, pulmonary complications 35.2%, shock 29.8% and pancreatic fistula 27.9%.
PD is a technically complex procedure with substantial associated morbidity and mortality. Infectious complications have been reported to occur in as many as 30% of patients following open PD.
Biliary colonization that arises from preoperative procedures for biliary drainage closely predicts infectious complications following PD. Besides biliary intervention, nutritional reserve and biliary or pancreatic anastomotic leaks are common factors linked to developing infectious complications following PD.
D'Angelica et al. Recently demonstrated the superiority of Piperacillin-tazobactam compared with cefoxitin as antimicrobial prophylaxis for PD: a randomized clinical trial in JAMA, with a significant reduction of postoperative SSI rate.
One of the main risk factors for infectious complications and especially surgical site infections, but also post-operative pancreatic fistula is bacteriobilia, defined by the bile contamination by microorganism(s) related to preoperative biliary drainage.
A significant decrease in all-type SSI and organ-space SSI with Broad spectrum antibiotics was observed after open PD, as reported by Kone et al. or De Grandi et al. According to Kone et al. on subgroup analysis, only patients with preoperative biliary stents and/ or jaundice (61% of PD patients) had an association between Broad-abx and decreased SSI. Numbered of surgeons modified their antibiotic usage in this setting of preoperative biliary drainage, as we also observed in France, where more than 50% prescribed a broad spectrum antibiotherapy intraoperatively only (antibioprophylaxis) or for 3 to 5 days.
The aim of this study is to determine whether a prophylactic treatment used only during surgery, or for 5 days with this treatment, in the clinical context of PD after biliary drainage, is effective in reducing surgical complications, particularly infectious ones.
Such results could reduce the need for prolonged anti-infectious treatments and reoperations (surgical and radiological). Hospital stays could also be shortened, with a positive impact on your quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Broad spectrum antibioprophylaxis | Active Comparator | Antibioprophylaxis with Piperacillin-tazobactam during DPC. |
|
| Broad spectrum antibiotherapy | Experimental | 5 days Antibiotherapy (Piperacillin-tazobactam) from surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibioprophylaxis (Piperacillin-tazobactam) | Drug | antibiotic prophylaxis during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Infectious complications at post-operative | Overall postsurgical morbidity, graded according to the Dindo/Clavien classification and CCI score | day 90 |
| Correlation between post-operative bacteriological samples and intraoperative bile samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lilian Schwarz | Contact | 0232888416 | +33 | lilian.schwarz@chu-rouen.fr |
| Julie Rondeaux, PhD | Contact | 0232885427 | +33 | julie.rondeaux@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de ROUEN | Rouen | 76031 | France |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39169298 | Derived | Schwarz L, Gillibert A, Rondeaux J, Lacroix E, Sa Cunha A, Joannes-Boyau O. Study protocol of the FRENCH24-ANIS study: postoperative anti-infective strategy following pancreaticoduodenectomy in patients with preoperative biliary stents-an intergroup FRENCH-ACHBT-SFAR prospective randomized controlled trial. BMC Surg. 2024 Aug 22;24(1):237. doi: 10.1186/s12893-024-02507-y. |
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| 5 days Antibiotherapy (Piperacillin-tazobactam) | Drug | 5 days Antibiotherapy from surgery |
|
|
Correlation between post-operative bacteriological samples and intraoperative bile samples (presence of bacterial strains)
| day 90 |
| Bacteriological resistance profiles | Incidence of fungal contamination | day 90 |
| Correlation between bacteriological and fungal contaminations | Correlation between bacteriological and fungal contaminations (presence of bacterial strains and fungal contamination) | day 90 |
| Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria | Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria | day 90 |
| Readmission rates and Duration of hospitalization | Readmission rates and Duration of hospitalization | day 90 |
| ID | Term |
|---|---|
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| ID | Term |
|---|---|
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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