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

March 18, 2019 updated by: Azienda Ospedaliera Universitaria Integrata Verona

Tri Stapler vs. Ultrasonic Scalpel in Distal Pancreatectomy

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy, 37134
        • Recruiting
        • Ospedale Policlinico GB Rossi
        • Principal Investigator:
          • Claudio Bassi, MD
        • Contact:
        • Principal Investigator:
          • Luca Landoni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stapler
Device: Stapler
for transection of the pancreas and pancreatic stump treatment
Active Comparator: ultrasonic shears
Device: ultrasonic shears
for transection of the pancreas and pancreatic stump treatment

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRUDY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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