Comparing two methods for pancreatic surgery to reduce complications
Influence of Pancreatic Transection With Cavitron Ultrasonic Surgical Aspirator (CUSA) on Postoperative Pancreatic Fistula Incidence - a Prospective Randomised Controlled Trial: the PANCUT Study
This study is testing whether a new tool called CUSA for pancreatic surgery can help reduce complications like pancreatic fistulas compared to traditional methods for patients having pancreatic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT06135012 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of using a cavitron ultrasonic surgical aspirator (CUSA) for transecting pancreatic tissue compared to traditional methods using a surgical scalpel or stapler. The study will involve 160 patients scheduled for elective pancreaticoduodenectomy, who will be randomly assigned to either the CUSA group or the control group. The primary focus is to assess the incidence of postoperative pancreatic fistula (POPF), a significant complication following pancreatic surgery. The trial is designed as a randomized controlled trial at a single center, adhering to SPIRIT guidelines.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for elective pancreaticoduodenectomy.
Not a fit: Patients with previous pancreatic surgeries, those undergoing immunosuppressive therapy, or pregnant individuals may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative pancreatic fistula, improving recovery and outcomes for patients undergoing pancreatic surgery.
How similar studies have performed: While there have been studies on various surgical techniques for pancreatic resections, the specific use of CUSA for this purpose is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or more * Patients capable of understanding the provided information about the study * Patients with signed informed consent * Planned elective pancreaticoduodenectomy for any indication Exclusion Criteria: * Patients aged less than 18 * Patient incapable of understanding the provided information about the study * Pregnancy * Previous surgical procedures on pancreas * Immunosuppressive therapy * Preoperative radiotherapy
Where this trial is running
Ljubljana
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Principal investigator: David Badovinac — Department of Abdominal Surgery, University Medical Centre Ljubljana
- Study coordinator: David Badovinac
- Email: david.badovinac@kclj.si
- Phone: +38615224788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.