An interventional study of Radiofrequency-assisted pancreas transection and Stapler assisted pancreas transection in Pancreas; Fistula, sponsored by Patricia Sanchez Velazquez. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Patricia Sanchez Velazquez · Not applicable, Interventional, and Treatment
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.
125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's enrollment of 112 is close to the median of 110 across 75 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →This is the only study on the registry with Patricia Sanchez Velazquez as lead sponsor.
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Exclusion Criteria:
Procedure: Radiofrequency-assisted pancreas transection
Procedure: Stapler assisted pancreas transection
Transection of the pancreas in distal pancreatectomy by applying a radio frequency device
Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard
Pancreas fistula
Defined by the updated 2016 ISGPF definition
Time frame: 90 days follow-up
In-hospital Mortality
30 days
Time frame: In-Hospital (30 days)
Morbidity
In terms of Clavien-Dindo and CCI classification
Time frame: 90 days follow-up
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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