Solid Pseudopapillary Neoplasm of the PancreasNCT04728750
Laparoscopic Enucleation of Frantz's Tumor of the Pancreas
An observational study of Solid Pseudopapillary Neoplasm of the Pancreas, run by Tecnologico de Monterrey at 1 site in Mexico.
Trial summary
The present study describes a 32-year-old female patient, in whom a preoperative imaging diagnosis confirmed a mass in the junction of the body and tail of the pancreas. Based on the anamnesis, on the preoperative diagnosis, and on the general status of the patient, the decision was made to performed laparoscopic… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Solid Pseudopapillary Neoplasm of the Pancreas
- What is being tested?
- Enucleation of a tumor of the pancreas
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteMexico
- Study dates
- 1 Dec 2020to 2 Jan 2021
- Phase
- Observational
- 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 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a diagnosed pancreatic tumor by image study.
Who may be able to join
- Patients with benign tumor of the pancreas
- Patients with a size tumor of less than 3 cm on the pancreas
Who cannot join
- Patients with a size tumor greater than 3 cm on the pancreas
- Malignant tumors of the pancreas
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Escuela Nacional de Medicina, Tecnologico de Monterrey
Monterrey, Nuevo León, 76140
About this study
Official title: Laparoscopic Enucleation of Frantz's Tumor of the Pancreas: Case Report and Literature Review
The present study describes a 32-year-old female patient, in whom a preoperative imaging diagnosis confirmed a mass in the junction of the body and tail of the pancreas. Based on the anamnesis, on the preoperative diagnosis, and on the general status of the patient, the decision was made to performed laparoscopic enucleation of the pancreatic tumor. The operation and postoperative recovery passed without complications. A minimally invasive surgical approach should be applied whenever the dimensions and the localization of the tumor permits it, bearing in mind all the benefits and advantages that this surgical technique has to offer.
- Being tested
- Enucleation of a tumor of the pancreas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enucleation of a tumor of the pancreasProcedure or surgery
Enucleation of a tumor in the pancreas is feasible and safe, as it offers a minimally invasive approach, and morbidities are fewer than open or conventional approach
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete enucleation of a tumor in the pancreas
Performance of a laparoscopic enucleation of a tumor in the pancreas, and compared it with a conventional approach
Measured: December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Dec 2020
- Primary completion1 Jan 2021
- Study completion2 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Pseudopapillary Neoplasm of the PancreasStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tecnologico de Monterrey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Ruiz Velasco Santacruz, Tecnologico de Monterrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728750
- Sponsor's protocol ID
- FT7831
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Enucleation of Frantz's Tumor of the Pancreas: Case Report and Literature Review
- ClinicalTrials.gov ID
- NCT04728750
- Acronym / sponsor ID
- FT7831
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Tecnologico de MonterreyUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 28 Jan 2021 (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.
The present study describes a 32-year-old female patient, in whom a preoperative imaging diagnosis confirmed a mass in the junction of the body and tail of the pancreas. Based on the anamnesis, on the preoperative diagnosis, and on the general status of the patient, the decision was made to performed laparoscopic enucleation of the pancreatic tumor. The operation and postoperative recovery passed without complications. A minimally invasive surgical approach should be applied whenever the dimensions and the localization of the tumor permits it, bearing in mind all the benefits and advantages that this surgical technique has to offer.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosed pancreatic tumor by image study.
Key inclusion criteria (2 listed)
- Patients with benign tumor of the pancreas
- Patients with a size tumor of less than 3 cm on the pancreas
Key exclusion criteria (2 listed)
- Patients with a size tumor greater than 3 cm on the pancreas
- Malignant tumors of the pancreas
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 |
|---|---|---|
| Enucleation of a tumor of the pancreasEnucleation of a tumor in the pancreas is feasible and safe, as it offers a minimally invasive approach, and morbidities are fewer than open or conventional approach | Procedure or surgery | – |
Primary outcome
Complete enucleation of a tumor in the pancreas
Time frame: December 2020
Performance of a laparoscopic enucleation of a tumor in the pancreas, and compared it with a conventional approach
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 28 Jan 2021.
- 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?
An observational study of Solid Pseudopapillary Neoplasm of the Pancreas, run by Tecnologico de Monterrey at 1 site in Mexico.
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 2 inclusion and 2 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 28 Jan 2021. 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 Mexico. 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?
Complete enucleation of a tumor in the pancreas (time frame: December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2021.