Clinical trial NCT05753735: eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce CR-POPF
Official title: eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce Clinically Relevant PostOperative Pancreatic Fistula: A Phase 2 Randomized Control Trial (X-POPF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Fistula
Keywords: Postoperative pancreatic fistula
Pancreatoduodenectomy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a randomized, controlled, unblinded, double-arm study with 2:1 randomization to the intervention group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subject undergoing planned, elective pancreatoduodenectomy at University Hospitals Cleveland Medical Center (UH CMC) for any indication.
* Age \>18 years. Pancreatoduodenectomy is rarely, if ever performed in the elective setting for the pediatric population at UH CMC. Therefore, this study will not include this small and different population of patients undergoing pancreatoduodenectomy.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
* Creatinine Clearance greater than 40 ml/min

Exclusion Criteria:

* Concurrent participation in another clinical trial, where participation in the proposed clinical trial that prohibits participation in this clinical trial, or where subjects would be actively receiving another investigational agent during the 90-day evaluation period of this study.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Piperacillin, Tazobactam, Amoxicillin, Clavulanic Acid or other agents used in this study.
* Subjects who are found to have another active infection or presumed infection at time of surgery who will be treated per standard of care with antibiotics regardless of randomization status.
* Subjects who are found to have metastatic disease at time of planned pancreatoduodenectomy, if surgery is otherwise aborted, or if total pancreatectomy is performed due to interoperative considerations
* Any subject who, while not having history of adverse reaction to similar chemical or biologic composition to Piperacillin, Tazobactam, Amoxicillin, Clavulanic Acid or other agents used in this study, develops a suspected drug reaction to the standard perioperative dose of antibiotic, prior to randomization.

Primary outcomes:
measure: Clinically Relevant (Grade B/C) Postoperative Pancreatic Fistula Rate
timeFrame: 56 days
Secondary outcomes:
measure: Mortality
timeFrame: At 30 days
measure: Mortality
timeFrame: At 90 days
measure: Index Postoperative Length of Stay
timeFrame: At 90 days
measure: Composite Length of Stay
timeFrame: At 90 days
measure: Readmission
timeFrame: At 30 days
measure: Readmission
timeFrame: At 90 days
measure: Delayed Gastric Emptying
timeFrame: At 90 days
measure: Image-guided Drain Placement
timeFrame: At 90 days
measure: Postpancreatectomy Hemorrhage
timeFrame: At 90 days
measure: Superficial Surgical Site Infection
timeFrame: At 90 days
measure: Deep Surgical Site Infections
timeFrame: At 90 days
measure: Deep Space Infections/Intra-abdominal Abscess
timeFrame: At 90 days
measure: Additional Drain Placement
timeFrame: At 90 days
measure: Unplanned Return to Operating Room
timeFrame: At 90 days
measure: Acute Kidney Injury
timeFrame: At 90 days
measure: C. Difficile Colitis
timeFrame: At 90 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Lee M. Ocuin, MD
role: PRINCIPAL_INVESTIGATOR
References: