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

Study Overview
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Brief Summary
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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)

Detailed Description
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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).

Official Title
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Influence of Pancreatic Transection With Cavitron Ultrasonic Surgical Aspirator (CUSA) on Postoperative Pancreatic Fistula Incidence - a Prospective Randomised Controlled Trial: the PANCUT Study

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Device: Cavitron ultrasonic surgical aspirator (CUSA)
* Other: Scalpel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transection with CUSA<br>Transection of pancreatic tissue using cavitron ultrasonic surgical aspirator (CUSA) and using metal clips for closing small intraparenchymal blood vessels and pancreatic branch ducts. | Device: Cavitron ultrasonic surgical aspirator (CUSA)<br>* Transection of pancreatic tissue with cavitron ultrasonic surgical aspirator (CUSA).<br>|
| Sham Comparator: Transection with scalpel/stapler<br>Standard transection of pancreatic tissue with a surgical scalpel without selective closure of small blood vessels and branch pancreatic ducts (in pancreaticoduodenectomy). | Other: Scalpel<br>* Transection of pancreatic tissue with scalpel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pancreatic fistula incidence | Evaluation and incidence of postoperative pancreatic fistula | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative septic complications | Intraabdominal collections, antibiotic treatment | 90 days | 
| Number of postoperative interventions | Percutaneous drain placement or reoperations | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic surgery, Pancreas transection, Postoperative complications, POPF