Clinical trial NCT04402346: Radiofrequency-assisted Transection of the Pancreas vs Stapler
Official title: Radiofrequency-assisted Transection of the Pancreas vs Stapler. A Phase III Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreas; Fistula
Keywords: Pancreas fistula
Distal pancreatectomy
Radiofrequency
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Pancreas fistula
timeFrame: 90 days follow-up
Secondary outcomes:
measure: In-hospital Mortality
timeFrame: In-Hospital (30 days)
measure: Morbidity
timeFrame: 90 days follow-up
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc de Salut Mar de Barcelona- Hospital del Mar
state: Cataluña
Study officials:
References:
citation: 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.