An interventional study of Cavitron ultrasonic surgical aspirator (CUSA) and Scalpel in Pancreatic Fistula, sponsored by University Medical Centre Ljubljana. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Treatment
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)
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).
125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 160 is above the median of 110 across 75 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transection of pancreatic tissue using cavitron ultrasonic surgical aspirator (CUSA) and using metal clips for closing small intraparenchymal blood vessels and pancreatic branch ducts.
Device: Cavitron ultrasonic surgical aspirator (CUSA)
Standard transection of pancreatic tissue with a surgical scalpel without selective closure of small blood vessels and branch pancreatic ducts (in pancreaticoduodenectomy).
Other: Scalpel
Transection of pancreatic tissue with cavitron ultrasonic surgical aspirator (CUSA).
Transection of pancreatic tissue with scalpel.
Postoperative pancreatic fistula incidence
Evaluation and incidence of postoperative pancreatic fistula
Time frame: 30 days
Postoperative septic complications
Intraabdominal collections, antibiotic treatment
Time frame: 90 days
Number of postoperative interventions
Percutaneous drain placement or reoperations
Time frame: 90 days
Hospital stay
Days in hospital
Time frame: 90 days
Volume of intraoperative blood loss
Blood loss during surgery
Time frame: 1 day
Operative time
Time spent for pancreas transection
Time frame: 1 day
Plan to share: No
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University Medical Centre Ljubljana