Comparing radiofrequency-assisted pancreas transection to stapler-assisted transection
Radiofrequency-assisted Transection of the Pancreas vs Stapler. A Phase III Randomized Clinical Trial.
NA · Hospital del Mar · NCT04402346
This study tests if a new method using radiofrequency to cut the pancreas can lower the chances of complications compared to the standard stapler method for patients having surgery for pancreatic tumors.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital del Mar (other) |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT04402346 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of radiofrequency-assisted pancreas transection in reducing the incidence of postoperative pancreatic fistula compared to the traditional stapler method. It is a Phase III multicenter, randomized study involving patients undergoing distal pancreatectomy for various pancreatic neoplasms. Participants will be randomly assigned to either the radiofrequency group or the control group receiving stapler-assisted transection, with various clinical and demographic factors being assessed as secondary endpoints.
Who should consider this trial
Good fit: Ideal candidates include patients with solid or cystic pancreatic neoplasms who are scheduled for distal pancreatectomy.
Not a fit: Patients requiring pancreatectomy at the neck level or those with severe comorbidities (ASA≥IV) may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of postoperative complications for patients undergoing distal pancreatectomy.
How similar studies have performed: While this approach is innovative, similar studies have shown promising results in reducing postoperative complications with alternative techniques.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Barcelona, Catalonia
- Parc de Salut Mar de Barcelona- Hospital del Mar — Barcelona, Catalonia, Spain (RECRUITING)
Study contacts
- Study coordinator: Patricia Sánchez-Velázquez, MD PhD FEBS
- Email: Psanchezvelazquez@psmar.cat
- Phone: +34 932483207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreas, Fistula, Pancreas fistula, Distal pancreatectomy, Radiofrequency