Pancreatoduodenectomy, Whipple Procedure
Conditions
Keywords
pancreatoduodenectomy, whipple procedure, sutures
Brief summary
The purpose of this study is to determine if the use of antiseptic-coated sutures is better than the use of the standard sutures in preventing postoperative fistulas within 90 days after pancreatoduodenectomy.
Detailed description
This study is a randomized-controlled trial comparing the rate of post-operative pancreatic fistula (POPF) in patients undergoing pancreatoduodenectomy. This is a superiority study designed to determine whether the use of antiseptic-coated sutures (intervention arm) is superior to standard sutures (control arm) in regard to clinically significant POPF within 90 days following pancreatoduodenectomy. Patients will be randomized to receive either a pancreatoduodenectomy surgery utilizing antiseptic coated sutures or with non-coated standard sutures. The study hypothesize that the use of antiseptic-coated sutures will be associated with a reduction in the rate of POPF. Both sutures are currently available at our center and utilized in the procedure of interest.
Interventions
DEVICEStandard (non-antiseptic coated) suture will be used.
This is an operation to treat tumors and other conditions in the pancreas, small intestine, and bile ducts. It involves removing the head of the pancreas, the first part of the small intestine, the gallbladder, and the bile duct. Part of the procedure involves sutures. A suture(s) is a stitch or row of stitches holding together the edges of a wound or surgical incision
DEVICETriclosan/antiseptic -coated suture
Triclosan/antiseptic -coated suture will be used. Ethicon PDSTM Plus Antibacterial Suture will be used at the layer of the pancreatojejunostomy and for the duration of the case.
Sponsors
The Cleveland Clinic
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be undergoing a scheduled pancreatoduodenectomy. * Age ≥18 years. * Subjects must have the ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Patients \< 18 years old * Patients who are pregnant * Patients with history of previous pancreatic surgery * Patients who are unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the rate of postoperative pancreatic fistula | up to 90 days post-operative | comparison of the rate of postoperative pancreatic fistula- Biochemical leak |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Rate of clinically significant POPF | up to 90-days post-operative | Improvement in Rate of clinically significant POPF (Grade B and C defined by ISGLS definition) |
| Improvement in SSI rates between groups using CDC classification | up to 90-days post-operative | Improvement in SSI rates between groups using CDC classification (superficial, deep, organ space) |
| Hospital Length of Stay | up to 90-day post operative | Duration of hospital admission, measured in days, during index presentation for pancreatoduodenectomy. This will subsequently be compared among our two cohorts (standard suture vs antiseptic suture) |
| Length of ICU stay | up to 90-day post operative | Duration of Intensive care unit admission, measured in days, during index presentation for pancreatoduodenectomy, or during convalescence from surgery. This will subsequently be compared among our two cohorts (standard suture vs antiseptic suture) |
| Surgical Site Infection | up to 90-day post operative | An infection that occurs in the part of the body where the surgery took place and includes superficial, deep, and organ space infections |
| Surgical site occurrence | Up to 90 days post-operative | Non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous or purulent drainage, stitch abscess, seroma, hematoma, wound dehiscence, and enterocutaneous fistula |
| Surgical Site Occurrence requiring Procedural Intervention | up to 90 days post-operative | Interventions to address wound healing issues or complications including wound opening or debridement, suture excision, percutaneous drainage. This includes to address superficial, deep, and organ space healing concerns |
| Post operative pancreatic fistula interventions | Up to 90 days post-operative | Postoperative interventions related to clinically relevant postoperative pancreatic leak (defined by 2016 International Study Group of Pancreatic Fistula) including percutaneous, endoscopic and surgical interventions. |
Countries
United States
Contacts
CONTACTChristine Moegling, BS
PRINCIPAL_INVESTIGATORToms Augustin, MD
The Cleveland Clinic
Outcome results
None listed