Tumor of PancreasReSiPaTNENCT05528614
Evaluation of the Results of Simultaneous Pancreatic and Hepatic Resections for Metastatic Neuroendocrine Tumors.
An observational study of Tumor of Pancreas, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The indications for synchronous liver resection for metastatic neuroendocrine tumors of pancreatic origin remain debated and poorly described in the literature. The reported mortality of this type of simultaneous resection remains very high, especially when a cephalic duodenopancreatectomy is associated with a hepatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor of Pancreas
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2022to 13 Jan 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Major subjects (≥18 years old) having had a first pancreatic resection for NET with resections of synchronous metastases
Who may be able to join
- Major subjects (≥18 years old)
- Subject having had a first pancreatic resection for NET with resections of synchronous metastases
- Subject having had a first pancreatic resection for NET followed by a delayed resection of synchronous metastases
- Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research
Who cannot join
- Subject who expressed their opposition to participating in the study
- Pregnant women
- Subject under safeguard of justice
- Subjects under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Générale, Hépatique, Endocrinienne et Transplantation - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Evaluation of the Results of Simultaneous Pancreatic and Hepatic Resections for Metastatic Neuroendocrine Tumors
The indications for synchronous liver resection for metastatic neuroendocrine tumors of pancreatic origin remain debated and poorly described in the literature.
The reported mortality of this type of simultaneous resection remains very high, especially when a cephalic duodenopancreatectomy is associated with a hepatic resection (up to 40%). The benefit in terms of survival remains to be evaluated. The ReSiPaTNE study proposes to create a retrospective cohort of simultaneous pancreatic and hepatic resections for metastatic neuroendocrine tumors in order to evaluate the short and long term results of this type of resection. The evaluation of the results of this type of resection may be useful for the selection of patients for treatment.
- Conditions
- Tumor of Pancreas
- Keywords
- Tumor of Pancreas, Metastatic neuroendocrine tumors, Hepatic resection, Pancreatic resection
- Medical subject headings
- Pancreatic Neoplasms, Neuroendocrine Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity and mortality of simultaneous pancreatic and hepatic resectio
Measured: Morbidity and mortality at 90 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start13 Jan 2022
- Primary completion13 Nov 2022
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor of PancreasStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pietro ADDEO, MD, Principal investigator, Service de Chirurgie Générale, Hépatique, Endocrinienne et Transplantation - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528614
- Sponsor's protocol ID
- 8511
- Acronym
- ReSiPaTNE
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Results of Simultaneous Pancreatic and Hepatic Resections for Metastatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT05528614
- Acronym / sponsor ID
- ReSiPaTNE / 8511
- Conditions
- Tumor of Pancreas
- Keywords
- Tumor of Pancreas, Metastatic neuroendocrine tumors, Hepatic resection, Pancreatic resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 13 Nov 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 6 Sep 2022 (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 indications for synchronous liver resection for metastatic neuroendocrine tumors of pancreatic origin remain debated and poorly described in the literature.
The reported mortality of this type of simultaneous resection remains very high, especially when a cephalic duodenopancreatectomy is associated with a hepatic resection (up to 40%). The benefit in terms of survival remains to be evaluated. The ReSiPaTNE study proposes to create a retrospective cohort of simultaneous pancreatic and hepatic resections for metastatic neuroendocrine tumors in order to evaluate the short and long term results of this type of resection. The evaluation of the results of this type of resection may be useful for the selection of patients for treatment.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subjects (≥18 years old) having had a first pancreatic resection for NET with resections of synchronous metastases
Key inclusion criteria (4 listed)
- Major subjects (≥18 years old)
- Subject having had a first pancreatic resection for NET with resections of synchronous metastases
- Subject having had a first pancreatic resection for NET followed by a delayed resection of synchronous metastases
- Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research
Key exclusion criteria (4 listed)
- Subject who expressed their opposition to participating in the study
- Pregnant women
- Subject under safeguard of justice
- Subjects under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative morbidity and mortality of simultaneous pancreatic and hepatic resectio
Time frame: Morbidity and mortality at 90 postoperative days
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 8 Nov 2023.
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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.
Pietro ADDEO, MD principal investigator
Service de Chirurgie Générale, Hépatique, Endocrinienne et Transplantation - CHU de Strasbourg - France
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 Tumor of Pancreas, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 4 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 8 Nov 2023. 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 France. 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?
Postoperative morbidity and mortality of simultaneous pancreatic and hepatic resectio (time frame: Morbidity and mortality at 90 postoperative days). 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 8 Nov 2023.