NCT04402346: TRANSPAIRE

Radiofrequency-assisted Transection of the Pancreas vs Stapler

Recruiting now NA Last updated 7 June 2024

What this trial tests

NA trial testing Radiofrequency-assisted pancreas transection in Pancreas; Fistula in 110 participants. Currently enrolling.

Timeline

15 February 2021

Primary endpoint
31 December 2024

30 June 2025

Quick facts

Lead sponsor	Patricia Sanchez Velazquez
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	110
Start date	15 February 2021
Primary completion	31 December 2024
Estimated completion	30 June 2025
Sites	1 location across Spain

Drugs / interventions tested

• Radiofrequency-assisted pancreas transection
• Stapler assisted pancreas transection

Conditions studied

• Pancreas; Fistula — all drugs for Pancreas; Fistula →

Sponsor

Patricia Sanchez Velazquez

Who can join

18 and older, any sex, with Pancreas; Fistula. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiofrequency-assisted transection of the pancreas vs stapler in distal pancreatectomy: a propensity score matched cohort analysis.
   Pueyo-Périz E, Téllez-Marquès C, Radosevic A, Morató O, et al · · 2022 · cited 3× · PMID 35523857 · DOI 10.1038/s41598-022-11583-0
2. Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy: study protocol for a multicentric randomised clinical trial (TRANSPAIRE).
   Sánchez-Velázquez P, Pueyo-Périz E, Álamo JM, Suarez Artacho G, et al · · 2022 · cited 1× · PMID 36332946 · DOI 10.1136/bmjopen-2022-062873