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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Fistula
• Intervention / Treatment: Device: Cavitron ultrasonic surgical aspirator (CUSA); Other: Scalpel

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).

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Badovinac; Phone Number: +38615224788; Email: david.badovinac@kclj.si
• Study Contact Backup: Name: Benjamin Hadžialjević; Phone Number: +38615224788; Email: benjamin.hadzialjevic@kclj.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • University Medical Centre Ljubljana
    • Contact: David Badovinac; Phone Number: +38615224788; Email: david.badovinac@kclj.si
    • Contact: Benjamin Hadžialjević; Email: benjamin.hadzialjevic@kclj.si
    • Principal Investigator: David Badovinac
    • Sub-Investigator: Aleš Tomažič
    • Sub-Investigator: Benjamin Hadžialjević
    • Sub-Investigator: Hana Zavrtanik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Cavitron ultrasonic surgical aspirator (CUSA); Transection of pancreatic tissue with cavitron ultrasonic surgical aspirator (CUSA).
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).	Other: Scalpel; Transection of pancreatic tissue with scalpel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pancreatic fistula incidence	Evaluation and incidence of postoperative pancreatic fistula	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative septic complications	Intraabdominal collections, antibiotic treatment	90 days
Number of postoperative interventions	Percutaneous drain placement or reoperations	90 days
Hospital stay	Days in hospital	90 days
Volume of intraoperative blood loss	Blood loss during surgery	1 day
Operative time	Time spent for pancreas transection	1 day

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Principal Investigator: David Badovinac, Department of Abdominal Surgery, University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative complications; Pancreatic surgery; POPF; Pancreas transection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: 20230052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No