Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy

Azienda Ospedaliera Universitaria Integrata Verona152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

152

Conditions

Pancreatic Fistula

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of Pancreatic fistula

pancreatic fistula according to International Study Group of Pancreatic Surgery (ISGPS) 2017 definition

Time frame: 90 days

Secondary Outcomes

Operative time

Time frame: intra-operatively

Rate of postoperative overall and specific complications

abdominal collections, delayed gastric emptying, hemorrhage, sepsis, wound infections

Time frame: 30 days, 90 days

Rate of re-operations or percutaneous drainage

re-operations rate or percutaneous drainage rate

Time frame: 30 days, 90 days

Cost-analysis

intra and post-operative costs