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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880773
Recruitment Status : Unknown
Verified January 2019 by Azienda Ospedaliera Universitaria Integrata Verona.
Recruitment status was:  Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Integrata Verona

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pancreatic Fistula Distal Pancreatectomy Device: Stapler Device: ultrasonic shears Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Tri Stapler vs. Ultrasonic Scalpel in Distal Pancreatectomy
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Pancreatic fistula [ Time Frame: 90 days ]
    pancreatic fistula according to International Study Group of Pancreatic Surgery (ISGPS) 2017 definition


Secondary Outcome Measures :
  1. Operative time [ Time Frame: intra-operatively ]
  2. Rate of postoperative overall and specific complications [ Time Frame: 30 days, 90 days ]
    abdominal collections, delayed gastric emptying, hemorrhage, sepsis, wound infections

  3. Rate of re-operations or percutaneous drainage [ Time Frame: 30 days, 90 days ]
    re-operations rate or percutaneous drainage rate

  4. Cost-analysis [ Time Frame: 90 days ]
    intra and post-operative costs


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880773


Contacts
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Contact: Erica Secchettin 0458126254 erica.secchettin@aovr.veneto.it

Locations
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Italy
Ospedale Policlinico GB Rossi Recruiting
Verona, Italy, 37134
Contact: Luca Landoni, MD    0458126254 ext 0039    luca.landoni@aovr.veneto.it   
Principal Investigator: Claudio Bassi, MD         
Principal Investigator: Luca Landoni, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
More Information
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Publications:

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Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT03880773    
Other Study ID Numbers: TRUDY
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Fistula
Fistula
Pathological Conditions, Anatomical
 Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases