Clinical trial NCT03880773: Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy
Official title: Tri Stapler vs. Ultrasonic Scalpel in Distal Pancreatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Fistula
Distal Pancreatectomy
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Pancreatic fistula
timeFrame: 90 days
Secondary outcomes:
measure: Operative time
timeFrame: intra-operatively
measure: Rate of postoperative overall and specific complications
timeFrame: 30 days, 90 days
measure: Rate of re-operations or percutaneous drainage
timeFrame: 30 days, 90 days
measure: Cost-analysis
timeFrame: 90 days
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Ospedale Policlinico GB Rossi
Study officials:
References:
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citation: Zhang H, Zhu F, Shen M, Tian R, Shi CJ, Wang X, Jiang JX, Hu J, Wang M, Qin RY. Systematic review and meta-analysis comparing three techniques for pancreatic remnant closure following distal pancreatectomy. Br J Surg. 2015 Jan;102(1):4-15. doi: 10.1002/bjs.9653. Epub 2014 Nov 12.
citation: Kim H, Jang JY, Son D, Lee S, Han Y, Shin YC, Kim JR, Kwon W, Kim SW. Optimal stapler cartridge selection according to the thickness of the pancreas in distal pancreatectomy. Medicine (Baltimore). 2016 Aug;95(35):e4441. doi: 10.1097/MD.0000000000004441.
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