Pancreas; FistulaTRANSPAIRENCT04402346
Radiofrequency-assisted Transection of the Pancreas vs Stapler
A study testing Radiofrequency-assisted pancreas transection and Stapler assisted pancreas transection in people with Pancreas; Fistula, run by Patricia Sanchez Velazquez at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas; Fistula
- What is being tested?
- Radiofrequency-assisted pancreas transection and Stapler assisted pancreas transection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2021to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Parc de Salut Mar de Barcelona- Hospital del Mar
Barcelona, Catalonia, 08019
About this study
Official title: Radiofrequency-assisted Transection of the Pancreas vs Stapler. A Phase III Randomized Clinical Trial.
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
- Being tested
- Radiofrequency-assisted pancreas transection, Stapler assisted pancreas transection
- Keywords
- Pancreas fistula, Distal pancreatectomy, Radiofrequency
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency-assisted pancreas transectionProcedure or surgery
Transection of the pancreas in distal pancreatectomy by applying a radio frequency device
Stapler assisted pancreas transectionProcedure or surgery
Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency-assisted | Experimental | Not described Receives: Procedure: Radiofrequency-assisted pancreas transection |
| Stapler | Active comparator | Not described Receives: Procedure: Stapler assisted pancreas transection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreas fistula
Defined by the updated 2016 ISGPF definition
Measured: 90 days follow-up
Secondary outcomes (2)
In-hospital Mortality
30 days
Measured: In-Hospital (30 days)
Morbidity
In terms of Clavien-Dindo and CCI classification
Measured: 90 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start15 Feb 2021
- Primary completion31 Mar 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas; FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patricia Sanchez Velazquez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patricia Sanchez Velazquez, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402346
- Sponsor's protocol ID
- HMar_RF_transection_pancreas
- Acronym
- TRANSPAIRE
- Status last verified
- Jul 2026
- First submitted
- 20 May 2020
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36332946
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency-assisted Transection of the Pancreas vs Stapler. A Phase III Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04402346
- Acronym / sponsor ID
- TRANSPAIRE / HMar_RF_transection_pancreas
- Conditions
- Pancreas; Fistula
- Keywords
- Pancreas fistula, Distal pancreatectomy, Radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Patricia Sanchez VelazquezUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency-assisted | Experimental | Procedure: Radiofrequency-assisted pancreas transection |
| Stapler | Active comparator | Procedure: Stapler assisted pancreas transection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency-assisted pancreas transectionTransection of the pancreas in distal pancreatectomy by applying a radio frequency device | Procedure or surgery | Radiofrequency-assisted |
| Stapler assisted pancreas transectionTransection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard | Procedure or surgery | Stapler |
Primary outcome
Pancreas fistula
Time frame: 90 days follow-up
Defined by the updated 2016 ISGPF definition
2 secondary outcomes
In-hospital Mortality
Time frame: In-Hospital (30 days)
Morbidity
Time frame: 90 days follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Derived from this study: PubMed 36332946Sanchez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency-assisted pancreas transection and Stapler assisted pancreas transection in people with Pancreas; Fistula, run by Patricia Sanchez Velazquez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreas fistula (time frame: 90 days follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.