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

NCT06135012 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-11-18

No results posted yet for this study

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)

Conditions

  • Pancreatic Fistula

Interventions

DEVICE

Cavitron ultrasonic surgical aspirator (CUSA)

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

OTHER

Scalpel

Transection of pancreatic tissue with scalpel.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • David Badovinac · Department of Abdominal Surgery, University Medical Centre Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-07-31
Completion
2025-09-30

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06135012 on ClinicalTrials.gov