Radiofrequency-assisted Transection of the Pancreas vs Stapler

NCT04402346 | Recruiting DMC

• 1 other identifier: HMar_RF_transection_pancreas
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas; Fistula

Keywords

Pancreas fistula; Distal pancreatectomy; Radiofrequency

Outcome Measures

Primary Outcomes (1)

• Pancreas fistula

  Defined by the updated 2016 ISGPF definition

  90 days follow-up

Secondary Outcomes (2)

• In-hospital Mortality

  In-Hospital (30 days)

• Morbidity

  90 days follow-up

Study Arms (2)

Radiofrequency-assisted

EXPERIMENTAL

Procedure: Radiofrequency-assisted pancreas transection

Stapler

ACTIVE COMPARATOR

Procedure: Stapler assisted pancreas transection

Interventions

Radiofrequency-assisted pancreas transection PROCEDURE

Transection of the pancreas in distal pancreatectomy by applying a radio frequency device

Radiofrequency-assisted

Stapler assisted pancreas transection PROCEDURE

Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard

Stapler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Patricia Sanchez Velazquez: lead

Study Sites (1)

Parc de Salut Mar de Barcelona- Hospital del Mar

Barcelona, Catalonia, 08019, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 36332946 DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patricia Sánchez-Velázquez, MD PhD FEBS

CONTACT

+34 932483207; Psanchezvelazquez@psmar.cat

Fernando Burdío, MD PhD

CONTACT

fburdio@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: February 15, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)