Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy

Study Overview
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Brief Summary
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Several systematic reviews have investigated the management of the pancreatic stump in order to reduce the postoperative pancreatic fistula (POPF) rate after distal pancreatectomy (DP). The appropriate closure technique of the pancreatic stump is still debated. There is no published experience about the comparison of the Endo GIA Reinforced Reload with Tri-Staple Technology (TS) versus Harmonic Focus (US) after distal pancreatectomy (DP) regarding the reduction of POPF. The investigators want to compare the incidence of clinically-relevant POPF (CR-POPF) after DP, depending upon the transection technique (TS versus US). This is a randomized controlled, multicenter, patient-blinded, superiority trial. This protocol was designed according to the SPIRIT guidelines. Two groups of 76 patients (152 in total) with an indication for elective minimally invasive or open DP for a lesion of the body-tail of the pancreas. The two techniques analyzed are Endo GIA Reinforced Reload with Tri-Staple Technology (TS) and Harmonic Focus (US) as control. The primary endpoint is to evaluate the incidence of CR-POPF rate after DP. Secondary endpoints are intraoperative outcomes (blood loss, operative time and conversion of the minimally invasive procedure), postoperative outcomes (complications rate; hospitalization parameters to 90 days; mortality) and treatment costs.

Official Title
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Tri Stapler vs. Ultrasonic Scalpel in Distal Pancreatectomy

Conditions
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Pancreatic Fistula, Distal Pancreatectomy

Intervention / Treatment
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* Device: Stapler
* Device: ultrasonic shears


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for elective DP via a minimally invasive (laparoscopic or robotic) or open technique, either preserving the spleen or with splenectomy, depending on the diagnosis/nature of the tumor ASA score < 4 Ability of the subject to understand character and individual consequences of the clinical trial Written informed consent Exclusion Criteria: Pancreas thickness >17mm measured at the intraoperative ultrasound at the pancreatic transection level Metastatic disease Kidney or adrenal gland resection Arterial resection (celiac axis, superior mesenteric artery, hepatic artery) Intestinal resections and anastomoses or stoma Acute necrotizing and chronic pancreatitis Immune suppressed patients Pregnant women Patients with contraindications for distal pancreatectomy Impaired mental state or language problems

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stapler<br> | Device: Stapler<br>* for transection of the pancreas and pancreatic stump treatment<br>|
| Active Comparator: ultrasonic shears<br> | Device: ultrasonic shears<br>* for transection of the pancreas and pancreatic stump treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Pancreatic fistula | pancreatic fistula according to International Study Group of Pancreatic Surgery (ISGPS) 2017 definition | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | intra-operatively | 
| Rate of postoperative overall and specific complications | abdominal collections, delayed gastric emptying, hemorrhage, sepsis, wound infections | 30 days, 90 days | 
| Rate of re-operations or percutaneous drainage | re-operations rate or percutaneous drainage rate | 30 days, 90 days | 
| Cost-analysis | intra and post-operative costs | 90 days |