Radiofrequency-assisted Transection of the Pancreas vs Stapler (TRANSPAIRE)

Radiofrequency-assisted Transection of the Pancreas vs Stapler. A Phase III Randomized Clinical Trial.

Main objective: The main end-point of this study is to compare in a randomized clinical trial that radiofrequency-assisted pancreas transection (RF) reduces the incidence of postoperative pancreatic fistula (POPF) compared to the classical method of transection (stapler). As secondary end-points, other clinical and demographic variables of the patients will be evaluated (sex, age, ASA classification, consistency of the pancreas, as well as the type of procedure, open or laparoscopic surgery, estimated intraoperative bleeding, pancreatic duct size, duration of intervention, type of tumor and quality of lymphatic resection). Methodology: Phase III prospective multicenter study in patients undergoing distal pancreatectomy for any origin. All consecutive patients who undergo a distal pancreatectomy for any cause in a multicenter setting will be included. A simple randomization of the participants to the RFA group or to the control group (stapler) will be carried out. The incidence of pancreatic fistula will be assessed as main variable; predictive multivariable models with multiple regression for quantitative variables, logistic regression for categorical variables and Cox regression for survival analyzes. In addition to histological study, molecular analysis of resection specimen and clinical and radiological follow-up with volumetry of necrosis in the area of post-pancreatectomy transection will be performed.

Study Overview

• Status: Recruiting
• Conditions: Pancreas; Fistula
• Intervention / Treatment: Procedure: Radiofrequency-assisted pancreas transection; Procedure: Stapler assisted pancreas transection

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Sánchez-Velázquez, MD PhD FEBS; Phone Number: +34 932483207; Email: Psanchezvelazquez@psmar.cat
• Study Contact Backup: Name: Fernando Burdío, MD PhD; Email: fburdio@hotmail.com

Study Locations

• Spain
  • Cataluña
    • Barcelona, Cataluña, Spain, 08019
      • Recruiting
      • Parc de Salut Mar de Barcelona- Hospital del Mar
      • Contact: Patricia Sánchez-Velázquez, MD PhD FEBS; Email: Psanchezvelazquez@psmar.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Solid or cystic, benign or malign pancreas neoplasms.
• Patients undergoing a distal pancreatectomy, i.e pancreas transection beyond > 2 cm from the SMV (assessed by computer tomography or RM) with or without splenectomy
• Both open and laparoscopic approaches are valid.

Exclusion Criteria:

• Patients who required a pancreatectomy with transection at the level of the neck.
• Non-intervention group: only stapler transection will be accepted, other pancreatic transection methods will be excluded.
• Patients ASA≥IV
• Absence of informed consent
• Underage (<18 years)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency-assisted	Procedure: Radiofrequency-assisted pancreas transection; Transection of the pancreas in distal pancreatectomy by applying a radio frequency device
Active Comparator: Stapler	Procedure: Stapler assisted pancreas transection; Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pancreas fistula	Defined by the updated 2016 ISGPF definition	90 days follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital Mortality	30 days	In-Hospital (30 days)
Morbidity	In terms of Clavien-Dindo and CCI classification	90 days follow-up

Collaborators and Investigators

• Sponsor: Patricia Sanchez Velazquez

Publications and helpful links

General Publications

• Sanchez-Velazquez P, Pueyo-Periz E, Alamo JM, Suarez Artacho G, Gomez Bravo MA, Marcello M, Vicente E, Quijano Y, Ferri V, Caruso R, Dorcaratto D, Sabater L, Gonzalez Chavez P, Noguera J, Navarro Gonzalo A, Bellido-Luque J, Tellez-Marques C, Ielpo B, Burdio F. Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy: study protocol for a multicentric randomised clinical trial (TRANSPAIRE). BMJ Open. 2022 Nov 4;12(11):e062873. doi: 10.1136/bmjopen-2022-062873.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Radiofrequency; Distal pancreatectomy; Pancreas fistula
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula; Gastrointestinal Agents; Pancrelipase; Pancreatin
• Other Study ID Numbers: HMar_RF_transection_pancreas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No