Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy

Not Applicable

• Conditions: Pancreatic Fistula; Distal Pancreatectomy
• Interventions: Device: ultrasonic shears; Device: Stapler

• Registration Number: NCT03880773
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Status Verified: 2019-01
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-03-18
• Last Update Submitted: 2019-03-18
• Study First Posted: 2019-03-19
• Last Update Posted: 2019-03-19
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasonic shears	ultrasonic shears	-
Stapler	Stapler	-

Primary Outcome Measures

Name	Time	Method
Rate of Pancreatic fistula	90 days	pancreatic fistula according to International Study Group of Pancreatic Surgery (ISGPS) 2017 definition

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ospedale Policlinico GB Rossi; 🇮🇹 Verona, Italy