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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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cavitron ultrasonic surgical aspirator (CUSA) | Device | Transection of pancreatic tissue with cavitron ultrasonic surgical aspirator (CUSA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pancreatic fistula incidence | Evaluation and incidence of postoperative pancreatic fistula | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative septic complications | Intraabdominal collections, antibiotic treatment | 90 days |
| Number of postoperative interventions | Percutaneous drain placement or reoperations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Badovinac | Contact | +38615224788 | david.badovinac@kclj.si | |
| Benjamin Hadžialjević | Contact | +38615224788 | benjamin.hadzialjevic@kclj.si |
| Name | Affiliation | Role |
|---|---|---|
| David Badovinac | Department of Abdominal Surgery, University Medical Centre Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40462161 | Derived | 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. |
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Scalpel | Other | Transection of pancreatic tissue with scalpel. |
|
| 90 days |
| Hospital stay | Days in hospital | 90 days |
| Volume of intraoperative blood loss | Blood loss during surgery | 1 day |
| Operative time | Time spent for pancreas transection | 1 day |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |