Influence of Pancreatic Transection With Cavitron Ultrasonic Surgical Aspirator (CUSA) on Postoperative Pancreatic Fistula Incidence - a Prospective Randomised Controlled Trial: the PANCUT Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: To compare the outcomes after elective pancreatic resections using cavitron ultrasonic surgical aspirator (CUSA) and selective closure of small blood vessels and branch pancreatic ducts versus surgical scalpel or stapler for the transection of pancreatic tissue. Study design: A randomized controlled, single centre trial. Study population: Two groups of 80 patients (160 in total) scheduled for elective open pancreaticoduodenectomy (PD) for any indication. Intervention: Transection of pancreatic tissue with CUSA. Control: Standard transection of pancreatic tissue with surgical scalpel (in PD) or stapler (in DP)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Slovenia
University Medical Centre Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
David Badovinac
david.badovinac@kclj.si
+38615224788
Backup
Benjamin Hadžialjević
benjamin.hadzialjevic@kclj.si
+38615224788
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 160
Treatments
Experimental: Transection with CUSA
Transection of pancreatic tissue using cavitron ultrasonic surgical aspirator (CUSA) and using metal clips for closing small intraparenchymal blood vessels and pancreatic branch ducts.
Sham_comparator: Transection with scalpel/stapler
Standard transection of pancreatic tissue with a surgical scalpel without selective closure of small blood vessels and branch pancreatic ducts (in pancreaticoduodenectomy).
Sponsors
Leads: University Medical Centre Ljubljana

This content was sourced from clinicaltrials.gov