Cavitron Ultrasonic Surgical Aspirator (CUSA®) compared to conventional pancreatic transection in distal pancreatectomy for prevention of postoperative pancreatic fistulas – the randomized-controlled CUSA-1 pilot trial

Cavitron Ultrasonic Surgical Aspirator (CUSA®) compared to conventional pancreatic transection in distal pancreatectomy for prevention of postoperative pancreatic fistulas – the randomized-controlled CUSA-1 pilot trial - CUSA-1

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027474

Enrollment

Registered

2022-04-08

Start date

2023-04-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K86.9 C25.9

Interventions

Group 1: distal pancreatectomy using the CUSA for pancreatic transection Group 2: conventional distal pancreatectomy transection with scalpel or stapler

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: patient planned for elective open distal pancreatectomy, Patient age > 18 years Ability of subject to understand character and individual consequences of the clinical trial both, trial or control intervention are equally possible, according to intraoperative decision by the operating surgeon (evaluated intraoperatively), written informed consent

Exclusion criteria

Exclusion criteria: multivisceral resection > 3 organs, including arterial resection of coeliac trunc and/or SMA, minimally invasive surgery, no compliance or language problems, participation in another intervention-trial with interference of intervention and outcome of this study, trial or control intervention not possible to perform due to intraoperative decision of the operating surgeon (evaluated intraoperatively, reasons will be assessed)

Design outcomes

Primary

Measure	Time frame
occurence of postoperative Complications according Clavien-Dindo-Classification and occurrence of pancreatic fistulas within 30 days post operation	—

Secondary

Measure	Time frame
postoperative chylus fistula (according to ISGPS), postoperative bleeding (according to ISGPS), occurrence of biochemical leak (according to ISGPS), surgical site infection (according to CDC criteria), postoperative mortality within 30 days post operation (day of death, reason), occurrence of re-operations (reason) occurrence of re-interventions (kind of intervention) intraabdominal fluid collection (CDC), abscess (CDC) occurrence of burst abdomen (CDC) surgical site infection (CDC, superficial/ deep) re-hospitalization (day of readmission, reason) length of hospital stay (days) length of ICU stay (in days, postoperative, readmission) All secondary outcomes will be assessed until POD 30.	—

Measure

Time frame

postoperative chylus fistula (according to ISGPS), postoperative bleeding (according to ISGPS), occurrence of biochemical leak (according to ISGPS), surgical site infection (according to CDC criteria), postoperative mortality within 30 days post operation (day of death, reason), occurrence of re-operations (reason) occurrence of re-interventions (kind of intervention) intraabdominal fluid collection (CDC), abscess (CDC) occurrence of burst abdomen (CDC) surgical site infection (CDC, superficial/ deep) re-hospitalization (day of readmission, reason) length of hospital stay (days) length of ICU stay (in days, postoperative, readmission) All secondary outcomes will be assessed until POD 30.

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026