Clinical Risk Score to Predict Pancreatic Fistula after Pancreatoduodenectomy: Independent External Validation for Open and Laparoscopic Approaches.
Christopher R Shubert, Amy E Wagie, Michael B Farnell...
https://pubmed.ncbi.nlm.nih.gov/26296680Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07318493
Does Antiseptic Coated Suture Reduce Pancreatic Fistula Rate After Pancreatoduodenectomy: A Randomized Controlled Trial
Led by The Cleveland Clinic · Updated on 2026-01-21
436
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
E
Ethicon, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether antiseptic-coated sutures reduce the risk of postoperative pancreatic fistulas compared to standard sutures in patients undergoing pancreatoduodenectomy, a surgery involving removal of parts of the pancreas and nearby organs. This randomized controlled trial aims to see if using antiseptic-coated sutures can lower the rate of clinically significant fistulas within 90 days after surgery. Participants will be randomly assigned to receive either standard non-antiseptic sutures or triclosan/antiseptic-coated sutures during their pancreatoduodenectomy. The antiseptic-coated sutures, specifically Ethicon PDS Plus Antibacterial Sutures, will be used at the pancreatojejunostomy layer throughout the surgery. Both sutures are commonly used at the study center. Participants will be followed for up to 90 days after surgery to monitor for postoperative pancreatic fistulas and surgical site infections. Researchers will assess outcomes such as fistula rates, infection rates, hospital and ICU length of stay, and any interventions needed for fistulas. The total participation period involves surgery and a 90-day postoperative observation to evaluate safety and effectiveness measures.
CONDITIONS
Brief Title
Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Subjects must be undergoing a scheduled pancreatoduodenectomy.
- Age 18 years or older.
- Ability and willingness to sign a written informed consent document.
You will not qualify if you...
- Patients younger than 18 years old.
- Pregnant patients.
- Patients with a history of previous pancreatic surgery.
- Patients unable to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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Surgery
Duration - 1 day (surgery day)
Participants undergo pancreatoduodenectomy surgery using either antiseptic-coated sutures or standard sutures as part of their operation.
1 surgery visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 1 week
Participants receive immediate post-operative care following their pancreatoduodenectomy surgery, including monitoring for complications related to the surgery and sutures.
Daily in-hospital visits
Post-operative Follow-up
Duration - Up to 90 days post-operative
Participants are followed for up to 90 days after surgery to monitor for pancreatic fistula development, surgical site infections, and recovery progress.
Regular follow-up visits during the 90 days after surgery
Trial Site Locations
Total: 3 locations
1
Cleveland Clinic Akron
Akron, Ohio, United States, 44307
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
3
Cleveland Clinic Fairview Hospital
Fairview, Ohio, United States, 44111
Actively Recruiting
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Research Team
C
Christine Moegling, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Implementation of prospective, surgeon-driven, risk-based pathway for pancreatoduodenectomy results in improved clinical outcomes and first year cost savings of $1 million.
Christopher R Shubert, Michael L Kendrick, Elizabeth B Habermann...
https://pubmed.ncbi.nlm.nih.gov/29275974Extended 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.
Lee M Ocuin, Alexander Loftus, Mohamedraed Elshami...
https://pubmed.ncbi.nlm.nih.gov/37940433Outcomes following pancreatic resection: variability among high-volume providers.
Taylor S Riall, William H Nealon, James S Goodwin...
https://pubmed.ncbi.nlm.nih.gov/18656618Effect of Hospital Volume on In-hospital Morbidity and Mortality Following Pancreatic Surgery in Germany.
Christian Krautz, Ulrike Nimptsch, Georg F Weber...
https://pubmed.ncbi.nlm.nih.gov/28379871The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After.
Claudio Bassi, Giovanni Marchegiani, Christos Dervenis...
https://pubmed.ncbi.nlm.nih.gov/28040257Risk factors of pancreatic leakage after pancreaticoduodenectomy.
Yin-Mo Yang, Xiao-Dong Tian, Yan Zhuang...
https://pubmed.ncbi.nlm.nih.gov/15832417Risk analysis of pancreatic fistula after pancreatic head resection.
N Sato, K Yamaguchi, K Chijiiwa...
https://pubmed.ncbi.nlm.nih.gov/9790207