Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy (TRUDY)

Integrated University Hospital Trust of Verona

Status

Unknown

Conditions

Pancreatic Fistula

Distal Pancreatectomy

Treatments

Device: Stapler

Device: ultrasonic shears

Study type

Interventional

Funder types

Other

Identifiers

NCT03880773

TRUDY

Details and patient eligibility

About

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.

Enrollment

152 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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