NCT06135012

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

July 3, 2023

Last Update Submit

November 10, 2023

Conditions

Pancreatic Fistula

Keywords

Pancreatic surgeryPancreas transectionPostoperative complicationsPOPF

Outcome Measures

Primary Outcomes (1)

  • Postoperative pancreatic fistula incidence

    Evaluation and incidence of postoperative pancreatic fistula

    30 days

Secondary Outcomes (5)

  • Postoperative septic complications

    90 days

  • Number of postoperative interventions

    90 days

  • Hospital stay

    90 days

  • Volume of intraoperative blood loss

    1 day

  • Operative time

    1 day

Study Arms (2)

Transection with CUSA

EXPERIMENTAL

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 with scalpel/stapler

SHAM COMPARATOR

Standard transection of pancreatic tissue with a surgical scalpel without selective closure of small blood vessels and branch pancreatic ducts (in pancreaticoduodenectomy).

Other: Scalpel

Interventions

Cavitron ultrasonic surgical aspirator (CUSA)DEVICE

Transection of pancreatic tissue with cavitron ultrasonic surgical aspirator (CUSA).

Transection with CUSA
ScalpelOTHER

Transection of pancreatic tissue with scalpel.

Transection with scalpel/stapler

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (1)

  • Hadzialjevic B, Zavrtanik Carni H, Petric M, Dokic M, Trotovsek B, Tomazic A, Badovinac D. Influence of pancreas transection with cavitron ultrasonic surgical aspirator (CUSA) on incidence of postoperative pancreatic fistula after pancreatoduodenectomy (PANCUT): study protocol for a randomised controlled trial. Trials. 2025 Jun 4;26(1):190. doi: 10.1186/s13063-025-08898-4.

    PMID: 40462161DERIVED

MeSH Terms

Conditions

Pancreatic FistulaPostoperative Complications

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • David Badovinac

    Department of Abdominal Surgery, University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Badovinac

CONTACT

+38615224788david.badovinac@kclj.si

Benjamin Hadžialjević

CONTACT

+38615224788benjamin.hadzialjevic@kclj.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

November 18, 2023

Study Start

July 1, 2023

Primary Completion

July 31, 2025

Study Completion

September 30, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)