Clinical trial NCT06135012: Influence of Pancreatic Transection With CUSA on Postoperative Pancreatic Fistula Incidence (PANCUT)
Official title: Influence of Pancreatic Transection With Cavitron Ultrasonic Surgical Aspirator (CUSA) on Postoperative Pancreatic Fistula Incidence - a Prospective Randomised Controlled Trial: the PANCUT Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Fistula
Keywords: Pancreatic surgery
Pancreas transection
Postoperative complications
POPF
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility 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

Primary outcomes:
measure: Postoperative pancreatic fistula incidence
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative septic complications
timeFrame: 90 days
measure: Number of postoperative interventions
timeFrame: 90 days
measure: Hospital stay
timeFrame: 90 days
measure: Volume of intraoperative blood loss
timeFrame: 1 day
measure: Operative time
timeFrame: 1 day
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: Department of Abdominal Surgery, University Medical Centre Ljubljana
name: David Badovinac
role: PRINCIPAL_INVESTIGATOR
References: