Radiofrequency-assisted Transection of the Pancreas vs Stapler

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreas; Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Radiofrequency-assisted

Group Type EXPERIMENTAL

Radiofrequency-assisted pancreas transection

Intervention Type PROCEDURE

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

Stapler

Group Type ACTIVE_COMPARATOR

Stapler assisted pancreas transection

Intervention Type PROCEDURE

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

Interventions

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Radiofrequency-assisted pancreas transection

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

Intervention Type PROCEDURE

Stapler assisted pancreas transection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No