Pancreatic FistulaPANCUTNCT06135012
Influence of Pancreatic Transection With CUSA on Postoperative Pancreatic Fistula Incidence (PANCUT)
A study testing Cavitron ultrasonic surgical aspirator (CUSA) and Scalpel in people with Pancreatic Fistula, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Cavitron ultrasonic surgical aspirator (CUSA) and Scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jul 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
David Badovinac, +38615224788, david.badovinac@kclj.si
Benjamin Hadžialjević, benjamin.hadzialjevic@kclj.si
About this study
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
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)
Read the 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).
- Conditions
- Pancreatic Fistula
- Being tested
- Cavitron ultrasonic surgical aspirator (CUSA), Scalpel
- Keywords
- Pancreatic surgery, Pancreas transection, Postoperative complications, POPF
- Medical subject headings
- Pancreatic Fistula, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cavitron ultrasonic surgical aspirator (CUSA)Device
Transection of pancreatic tissue with cavitron ultrasonic surgical aspirator (CUSA).
ScalpelOther
Transection of pancreatic tissue with scalpel.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pancreatic fistula incidence
Evaluation and incidence of postoperative pancreatic fistula
Measured: 30 days
Secondary outcomes (5)
Postoperative septic complications
Intraabdominal collections, antibiotic treatment
Measured: 90 days
Number of postoperative interventions
Percutaneous drain placement or reoperations
Measured: 90 days
Hospital stay
Days in hospital
Measured: 90 days
Volume of intraoperative blood loss
Blood loss during surgery
Measured: 1 day
Operative time
Time spent for pancreas transection
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jul 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Badovinac, Principal investigator, Department of Abdominal Surgery, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135012
- Sponsor's protocol ID
- 20230052
- Acronym
- PANCUT
- Status last verified
- Nov 2023
- First submitted
- 3 Jul 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40462161
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06135012
- Acronym / sponsor ID
- PANCUT / 20230052
- Conditions
- Pancreatic Fistula
- Keywords
- Pancreatic surgery, Pancreas transection, Postoperative complications, POPF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transection with CUSA | Experimental | Device: 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. |
| Transection with scalpel/stapler | Sham comparator | Other: ScalpelStandard transection of pancreatic tissue with a surgical scalpel without selective closure of small blood vessels and branch pancreatic ducts (in pancreaticoduodenectomy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Patients aged less than 18
- Patient incapable of understanding the provided information about the study
- Pregnancy
- Previous surgical procedures on pancreas
- Immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cavitron ultrasonic surgical aspirator (CUSA)Transection of pancreatic tissue with cavitron ultrasonic surgical aspirator (CUSA). | Device | Transection with CUSA |
| ScalpelTransection of pancreatic tissue with scalpel. | Other | Transection with scalpel/stapler |
Primary outcome
Postoperative pancreatic fistula incidence
Time frame: 30 days
Evaluation and incidence of postoperative pancreatic fistula
5 secondary outcomes
Postoperative septic complications
Time frame: 90 days
Number of postoperative interventions
Time frame: 90 days
Hospital stay
Time frame: 90 days
Volume of intraoperative blood loss
Time frame: 1 day
Operative time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 40462161Hadzialjevic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Badovinac principal investigator
Department of Abdominal Surgery, University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cavitron ultrasonic surgical aspirator (CUSA) and Scalpel in people with Pancreatic Fistula, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Badovinac (+38615224788, david.badovinac@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pancreatic fistula incidence (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.