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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency-assisted | Experimental |
| |
| Stapler | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency-assisted pancreas transection | Procedure | Transection of the pancreas in distal pancreatectomy by applying a radio frequency device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pancreas fistula | Defined by the updated 2016 ISGPF definition | 90 days follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital Mortality | 30 days | In-Hospital (30 days) |
| Morbidity | In terms of Clavien-Dindo and CCI classification | 90 days follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Sánchez-Velázquez, MD PhD FEBS | Contact | +34 932483207 | Psanchezvelazquez@psmar.cat | |
| Fernando Burdío, MD PhD | Contact | fburdio@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc de Salut Mar de Barcelona- Hospital del Mar | Recruiting | Barcelona | Catalonia | 08019 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36332946 | Derived | 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. |
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
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| Stapler assisted pancreas transection | Procedure | Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |