eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce CR-POPF

Pancreatic Fistula Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753735
• Other study ID #: CASE2223
• Status: Recruiting
• Phase: Phase 2
• Start date: January 18, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: Lee M. Ocuin, MD
• Phone: 1-800-641-2422
• Email: CTUReferral[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: September 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	At 90 days
Secondary	Mortality	Rate of mortality	At 30 days
Secondary	Mortality	Rate of mortality	At 90 days
Secondary	Index Postoperative Length of Stay	Index postoperative length of stay	At 90 days
Secondary	Composite Length of Stay	Composite 90-day length of stay	At 90 days
Secondary	Readmission	Rate of readmission	At 30 days
Secondary	Readmission	Rate of readmission	At 90 days
Secondary	Delayed gastric emptying	Rate of delayed gastric emptying	At 90 days
Secondary	Image-guided drain placement	Rate of image-guided drain placement	At 90 days
Secondary	Postpancreatectomy hemorrhage	Presence of postpancreatectomy hemorrhage	At 90 days
Secondary	Superficial surgical site infection	Presence of superficial surgical site infection	At 90 days
Secondary	Deep surgical site infections	Presence of deep surgical site infections	At 90 days
Secondary	Deep space infections/intra-abdominal abscess	Presence of deep space infections/intra-abdominal abscess	At 90 days
Secondary	Additional drain placement	Rate of additional drain placement	At 90 days
Secondary	Unplanned return to operating room	Measuring occurrences of unplanned return to operating room	At 90 days
Secondary	Acute kidney injury	Rate of the presence of acute kidney injury	At 90 days
Secondary	C. difficile colitis	Rate of the presence of C. difficile colitis	At 90 days