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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06135012
Other study ID # 20230052
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date September 30, 2025

Study information

Verified date November 2023
Source University Medical Centre Ljubljana
Contact David Badovinac
Phone +38615224788
Email david.badovinac@kclj.si
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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)


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date September 30, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Cavitron ultrasonic surgical aspirator (CUSA)
Transection of pancreatic tissue with cavitron ultrasonic surgical aspirator (CUSA).
Other:
Scalpel
Transection of pancreatic tissue with scalpel.

Locations

Country Name City State
Slovenia University Medical Centre Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pancreatic fistula incidence Evaluation and incidence of postoperative pancreatic fistula 30 days
Secondary Postoperative septic complications Intraabdominal collections, antibiotic treatment 90 days
Secondary Number of postoperative interventions Percutaneous drain placement or reoperations 90 days
Secondary Hospital stay Days in hospital 90 days
Secondary Volume of intraoperative blood loss Blood loss during surgery 1 day
Secondary Operative time Time spent for pancreas transection 1 day
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