Pancreatic and Periampullary TumorsDUOPAN-EPAMNCT02803814
Pancreatoduodenectomy in Pancreatic and Periampullary Tumors
A study testing Superior mesenteric artery approach for pancreatoduodenectomy and Classic approach for pancreatoduodenectomy in people with Pancreatic and Periampullary Tumors, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
Background: Recently it has been observed in pancreatic cancer that after apparently complete surgical resection, histological examination of the surgical specimen according to a standard protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic and Periampullary Tumors
- What is being tested?
- Superior mesenteric artery approach for pancreatoduodenectomy and Classic approach for pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to 19 Dec 2018
- 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
- Patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy
Who cannot join
- Patients with hepatic or peritoneal metastasis
- Patients with irresectable tumor
- Patients with R2 resection
- Patients Grade IV of the American Society of Anesthesiology Score
- Patients with neoadjuvant treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pancreatoduodenectomy in Pancreatic and Periampullary Tumors: Initial Approach of the Superior Mesenteric Artery Versus Classical Approach: A Prospective, Randomized, Multicenter Study
Background: Recently it has been observed in pancreatic cancer that after apparently complete surgical resection, histological examination of the surgical specimen according to a standard protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. To increase the resection margin and reduce such high infiltration rate, a new surgical approach based on the initial dissection of the superior mesenteric artery has been advocated.
Aims: To compare the rate of free resection margin (R0) and oncological results of two possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area: the classic approach versus the initial approach of the superior mesenteric artery.
Methodology: Prospective, randomized, multicenter study in which patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy. In a group the classical approach from the superior mesenteric vein will be performed and in the other group an initially dissecting the superior mesenteric artery approach will be carried out. 116 patients are required and the main variables considered are: free margin rates (R0) or infiltrated by tumor (R1), postoperative morbidity, mortality, local and systemic recurrence, disease-free interval and survival at 1, 3 and 5 years.
- Conditions
- Pancreatic and Periampullary Tumors
- Being tested
- Superior mesenteric artery approach for pancreatoduodenectomy, Classic approach for pancreatoduodenectomy
- Keywords
- Pancreatoduodenectomy, Pancreatic tumors, Periampullary tumors
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior mesenteric artery approach for pancreatoduodenectomyProcedure or surgery
Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the superior mesenteric artery approach
Classic approach for pancreatoduodenectomyProcedure or surgery
Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the classical approach
| Study group | Role | What they receive |
|---|---|---|
| Superior mesenteric artery approach | Experimental | Initial approach of the superior mesenteric artery to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area Receives: Procedure: Superior mesenteric artery approach for pancreatoduodenectomy |
| Classic approach | Active comparator | Classic approach to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area Receives: Procedure: Classic approach for pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of free resection margin (R0)
Histological examination of the surgical specimen
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
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 Pancreatic and Periampullary TumorsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803814
- Sponsor's protocol ID
- DUOPAN-EPAM
- Acronym
- DUOPAN-EPAM
- Status last verified
- Feb 2018
- First submitted
- 23 May 2016
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sabater L, Cugat E, Serrablo A, Suarez-Artacho G, Diez-Valladares L, Santoyo-Santoyo J, Martin-Perez E, Ausania F, Lopez-Ben S, Jover-Navalon JM, Garces-Albir M, Garcia-Domingo MI, Serradilla M, Perez-Aguirre E, Sanchez-Perez B, Di Martino M, Senra-Del-Rio P, Falgueras-Verdaguer L, Carabias A, Gomez-Mateo MC, Ferrandez A, Dorcaratto D, Munoz-Forner E, Fondevila C, Padillo J. Does the Artery-first Approach Improve the Rate of R0 Resection in Pancreatoduodenectomy?: A Multicenter, Randomized, Controlled Trial. Ann Surg. 2019 Nov;270(5):738-746. doi: 10.1097/SLA.0000000000003535.
PubMed 31498183
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatoduodenectomy in Pancreatic and Periampullary Tumors: Initial Approach of the Superior Mesenteric Artery Versus Classical Approach: A Prospective, Randomized, Multicenter Study
- ClinicalTrials.gov ID
- NCT02803814
- Acronym / sponsor ID
- DUOPAN-EPAM / DUOPAN-EPAM
- Conditions
- Pancreatic and Periampullary Tumors
- Keywords
- Pancreatoduodenectomy, Pancreatic tumors, Periampullary tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Feb 2016 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
Background: Recently it has been observed in pancreatic cancer that after apparently complete surgical resection, histological examination of the surgical specimen according to a standard protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. To increase the resection margin and reduce such high infiltration rate, a new surgical approach based on the initial dissection of the superior mesenteric artery has been advocated.
Aims: To compare the rate of free resection margin (R0) and oncological results of two possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area: the classic approach versus the initial approach of the superior mesenteric artery.
Methodology: Prospective, randomized, multicenter study in which patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy. In a group the classical approach from the superior mesenteric vein will be performed and in the other group an initially dissecting the superior mesenteric artery approach will be carried out. 116 patients are required and the main variables considered are: free margin rates (R0) or infiltrated by tumor (R1), postoperative morbidity, mortality, local and systemic recurrence, disease-free interval and survival at 1, 3 and 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superior mesenteric artery approach | Experimental | Procedure: Superior mesenteric artery approach for pancreatoduodenectomyInitial approach of the superior mesenteric artery to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area |
| Classic approach | Active comparator | Procedure: Classic approach for pancreatoduodenectomyClassic approach to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy
Key exclusion criteria (5 listed)
- Patients with hepatic or peritoneal metastasis
- Patients with irresectable tumor
- Patients with R2 resection
- Patients Grade IV of the American Society of Anesthesiology Score
- Patients with neoadjuvant treatment
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 |
|---|---|---|
| Superior mesenteric artery approach for pancreatoduodenectomyPancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the superior mesenteric artery approach | Procedure or surgery | Superior mesenteric artery approach |
| Classic approach for pancreatoduodenectomyPancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the classical approach | Procedure or surgery | Classic approach |
Primary outcome
Rate of free resection margin (R0)
Time frame: 1 month
Histological examination of the surgical specimen
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 22 Jul 2020.
- Derived from this study: PubMed 31498183Sabater L, Cugat E, Serrablo A, Suarez-Artacho G, Diez-Valladares L, Santoyo-Santoyo J, Martin-Perez E, Ausania F, Lopez-Ben S, Jover-Navalon JM, Garces-Albir M, Garcia-Domingo MI, Serradilla M, Perez-Aguirre E, Sanchez-Perez B, Di Martino M, Senra-Del-Rio P, Falgueras-Verdaguer L, Carabias A, Gomez-Mateo MC, Ferrandez A, Dorcaratto D, Munoz-Forner E, Fondevila C, Padillo J. Does the Artery-first Approach Improve the Rate of R0 Resection in Pancreatoduodenectomy?: A Multicenter, Randomized, Controlled Trial. Ann Surg. 2019 Nov;270(5):738-746. doi: 10.1097/SLA.0000000000003535.
- 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 Superior mesenteric artery approach for pancreatoduodenectomy and Classic approach for pancreatoduodenectomy in people with Pancreatic and Periampullary Tumors, run by Fundación para la Investigación del Hospital Clínico de Valencia 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 1 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 22 Jul 2020. 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?
Rate of free resection margin (R0) (time frame: 1 month). 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 NCT02803814, 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 22 Jul 2020.