NCT06135012

Influence of Pancreatic Transection With CUSA on Postoperative Pancreatic Fistula Incidence (PANCUT)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Rationale: Postoperative pancreatic fistula (POPF) is one of the major causes of morbidity and mortality after pancreatic resections. There is no predominant surgical technique of pancreatic stump closure in distal pancreatectomy (DP) or formation of pancreaticojejunostomy in pancreaticoduodenectomy (PD) proven to prevent/lower POPF incidence. Cavitron ultrasonic surgical aspirator (CUSA) selectively removes tissue parenchyma, evading blood vessels and pancreatic ducts which could consequently be selectively ligated. Such technique could anull pancreatic juice drainage from branch ducts and provide better (skeletonised) view of the main duct to from an anastomosis (or to ligate it in DP) and thus lower the incidence of POPF formation. Objective: To compare transection of pancreatic tissue with CUSA and selective closure of small blood vessels and branch pancreatic ducts with transection with surgical scalpel or stapler in elective pancreatic resections regarding the incidence of POPF. Study design: A randomized controlled, single centre trial. The study protocol was designed according to the SPIRIT guidelines. 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). Main study parameters/endpoints: Primary outcome is the incidence of POPF. Main secondary outcomes are intraoperative outcomes (such as blood loss and operative time), postoperative outcomes (such as complications, time to functional recovery and hospital stay).

Conditions

• Pancreatic Fistula

Interventions

Type	Name	Description
DEVICE	Cavitron ultrasonic surgical aspirator (CUSA)	Transection of pancreatic tissue with cavitron ultrasonic surgical aspirator (CUSA).
OTHER	Scalpel	Transection of pancreatic tissue with scalpel.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-07-31
• Completion: 2025-09-30
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: Slovenia