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

Not Applicable

Recruiting

• Conditions: Pancreatic Fistula
• Interventions: Other: Scalpel; Device: Cavitron ultrasonic surgical aspirator (CUSA)

• Registration Number: NCT06135012
• Lead Sponsor: University Medical Centre Ljubljana

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).

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-07-03
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-10
• Last Update Submitted: 2023-11-10
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-07-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transection with scalpel/stapler	Scalpel	Standard transection of pancreatic tissue with a surgical scalpel without selective closure of small blood vessels and branch pancreatic ducts (in pancreaticoduodenectomy).
Transection with CUSA	Cavitron ultrasonic surgical aspirator (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.

Primary Outcome Measures

Name	Time	Method
Postoperative pancreatic fistula incidence	30 days	Evaluation and incidence of postoperative pancreatic fistula

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia