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Principal investigator left the institution.
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The purpose of this clinical trial is to investigate if prolonged antibiotics after pancreatoduodenectomy can prevent the development of a pancreatic fistula and related complications. Participants who are at high risk of pancreatic fistula will be administered an extended course of antibiotics. While inpatient, the patient will receive these antibiotics through the vein, and after discharge, the antibiotics will be taken by mouth.
Pancreatoduodenectomy (PD) is a commonly performed surgical procedure utilized in the treatment of either localized malignancies or benign conditions that involve the pancreatic head, 2nd/3rd portions of the duodenum, ampulla of Vater, and distal biliary system. Historically, there has been little improvement in the rate of postoperative pancreatic fistula (POPF), which occurs in approximately 10-40% of patients, and is influenced by a number of factors, including surgeon experience, pancreatic gland texture, pancreatic duct size, and underlying diagnosis. POPF is the leaking of enterically contaminated and amylase-rich fluid from the pancreatic-jejunal anastomosis created during PD. This leak may lead to serious complications. The concept of antibiotic mitigation prior to development of a CR-POPF in patients at higher risk of developing CR-POPF is an option that will be explored in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard perioperative antibiotics | Active Comparator | The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively. |
|
| Extended antibiotic prophylaxis | Experimental | The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin/Tazobactam | Drug | Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Relevant (Grade B/C) Postoperative Pancreatic Fistula Rate | To demonstrate that extended antibiotic prophylaxis in patients with intermediate/high fistula risk score who undergo PD reduces the rate of clinically relevant postoperative pancreatic fistula in the intervention group. | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Rate of mortality | At 30 days |
| Mortality | Rate of mortality | At 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee M. Ocuin, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39424467 | Derived | Loftus A, Wu VS, Elshami M, Hue JJ, Ocuin LM. Hospital charge and resource use analysis of extended-spectrum penicillin antibiotic therapy after pancreatoduodenectomy in intermediate- and high-risk patients. HPB (Oxford). 2025 Jan;27(1):63-70. doi: 10.1016/j.hpb.2024.09.011. Epub 2024 Sep 28. | |
| 37940433 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Perioperative Antibiotics | The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively. Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days |
| FG001 | Extended Antibiotic Prophylaxis | The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants analyzed in the standard perioperative antibiotic group is zero because no patients were randomized to this arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Perioperative Antibiotics | The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively. Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinically Relevant (Grade B/C) Postoperative Pancreatic Fistula Rate | To demonstrate that extended antibiotic prophylaxis in patients with intermediate/high fistula risk score who undergo PD reduces the rate of clinically relevant postoperative pancreatic fistula in the intervention group. | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | 56 days |
|
120 days (from surgery through 30 days after the final dose of prophylactic antibiotic, approximately 90 days).
The number of participants at risk for All-Cause Mortality is zero in the Standard Perioperative Antibiotics group because no participants were randomized to this group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Perioperative Antibiotics | The control group will be treated according to current standard perioperative antibiotic practice, and perioperative antibiotics will not exceed 24 hours postoperatively. Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days |
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The Principal Investigator left University Hospitals Cleveland Medical Center. Therefore, this clinical trial was terminated prematurely.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nikola Anusic, Protocol Study Coordinator | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | 216-421-5986 | a.nikolau@icloud.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2024 | Aug 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2024 | Aug 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
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| ID | Term |
|---|---|
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
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This study will be a randomized, controlled, unblinded, double-arm study with 2:1 randomization to the intervention group.
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| Amoxicillin/ Clavulanic acid | Drug | Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics |
|
| Index Postoperative Length of Stay | Index postoperative length of stay | At 90 days |
| Composite Length of Stay | Composite 90-day length of stay | At 90 days |
| Readmission | Rate of readmission | At 30 days |
| Readmission | Rate of readmission | At 90 days |
| Delayed Gastric Emptying | Rate of delayed gastric emptying | At 90 days |
| Image-guided Drain Placement | Rate of image-guided drain placement | At 90 days |
| Postpancreatectomy Hemorrhage | Presence of postpancreatectomy hemorrhage | At 90 days |
| Superficial Surgical Site Infection | Presence of superficial surgical site infection | At 90 days |
| Deep Surgical Site Infections | Presence of deep surgical site infections | At 90 days |
| Deep Space Infections/Intra-abdominal Abscess | Presence of deep space infections/intra-abdominal abscess | At 90 days |
| Additional Drain Placement | Rate of additional drain placement | At 90 days |
| Unplanned Return to Operating Room | Measuring occurrences of unplanned return to operating room | At 90 days |
| Acute Kidney Injury | Rate of the presence of acute kidney injury | At 90 days |
| C. Difficile Colitis | Rate of the presence of C. difficile colitis | At 90 days |
| Ocuin LM, Loftus A, Elshami M, Hue JJ, Musonza T, Ammori JB, Winter JM, Hardacre JM. Extended antibiotic therapy is associated with a lower rate of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy in intermediate- and high-risk patients: A single-institution analysis. Surgery. 2024 Feb;175(2):477-483. doi: 10.1016/j.surg.2023.09.049. Epub 2023 Nov 7. |
| BG001 |
| Extended Antibiotic Prophylaxis |
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Extended Antibiotic Prophylaxis |
The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics |
|
|
| Secondary | Mortality | Rate of mortality | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 30 days |
|
|
|
| Secondary | Mortality | Rate of mortality | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| Secondary | Index Postoperative Length of Stay | Index postoperative length of stay | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Mean | Standard Deviation | Days | At 90 days |
|
|
|
| Secondary | Composite Length of Stay | Composite 90-day length of stay | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Mean | Standard Deviation | Days | At 90 days |
|
|
|
| Secondary | Readmission | Rate of readmission | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Number | number of readmissions | At 30 days |
|
|
|
| Secondary | Readmission | Rate of readmission | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Number | number of readmissions | At 90 days |
|
|
|
| Secondary | Delayed Gastric Emptying | Rate of delayed gastric emptying | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| Secondary | Image-guided Drain Placement | Rate of image-guided drain placement | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| Secondary | Postpancreatectomy Hemorrhage | Presence of postpancreatectomy hemorrhage | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| Secondary | Superficial Surgical Site Infection | Presence of superficial surgical site infection | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| Secondary | Deep Surgical Site Infections | Presence of deep surgical site infections | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| Secondary | Deep Space Infections/Intra-abdominal Abscess | Presence of deep space infections/intra-abdominal abscess | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| Secondary | Additional Drain Placement | Rate of additional drain placement | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| Secondary | Unplanned Return to Operating Room | Measuring occurrences of unplanned return to operating room | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| Secondary | Acute Kidney Injury | Rate of the presence of acute kidney injury | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| Secondary | C. Difficile Colitis | Rate of the presence of C. difficile colitis | Zero participants were randomized to the standard perioperative antibiotic arm. | Posted | Count of Participants | Participants | At 90 days |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Extended Antibiotic Prophylaxis | The intervention group will receive an extended duration of current standard perioperative antibiotics, then converted to amoxicillin/clavulanic at discharge Piperacillin/Tazobactam: Piperacillin/Tazobactam 3.375 g IV every 6 hours while inpatient following surgery, not to exceed 10 days Amoxicillin/ Clavulanic acid: Amoxicillin/ Clavulanic acid 875/125 mg every 12 hours after discharge to complete 10 days total antibiotics | 0 | 3 | 0 | 3 | 0 | 3 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D000658 | Amoxicillin |