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

Pancreatic Fistula Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135012
• Other study ID #: 20230052
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: University Medical Centre Ljubljana
• Contact: David Badovinac
• Phone: +38615224788
• Email: david.badovinac[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 30, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Device:
• Cavitron ultrasonic surgical aspirator (CUSA)
Transection of pancreatic tissue with cavitron ultrasonic surgical aspirator (CUSA).

Other:
• Scalpel
Transection of pancreatic tissue with scalpel.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pancreatic fistula incidence	Evaluation and incidence of postoperative pancreatic fistula	30 days
Secondary	Postoperative septic complications	Intraabdominal collections, antibiotic treatment	90 days
Secondary	Number of postoperative interventions	Percutaneous drain placement or reoperations	90 days
Secondary	Hospital stay	Days in hospital	90 days
Secondary	Volume of intraoperative blood loss	Blood loss during surgery	1 day
Secondary	Operative time	Time spent for pancreas transection	1 day