免费获得国外相关药品，最快 1 个工作日回馈药物信息
PreOPerative Imaging of NeuroEndocrine Tumors (POPINET)
Neuro-endocrine tumours (NET) are the most frequent tumours of the small intestine. In spite of their small size, these tumours have the particularity of forming mesenteric metastasis and ganglionic secondary lesions along the superior mesenteric axis, which is in close proximity to the superior mesenteric artery (SMA).
Surgery is the only curative treatment. The complete resection being a factor for good patient prognosis, risks of subsequent local complications (occlusion, bleeding) must be discussed. The limiting factor for resectability is arterial vascular invasion considering the risk of postoperative small bowel syndrome.
At the moment, the choice of imaging examination and its protocol is not standardized, nor the description of the tumoral mesenteric and ganglionic extension, especially the criteria defining a lymph node as lymphadenopathy. In addition, the complexity of SMA's anatomy and the absence of criteria for arterial invasion defining arterial invasion may lead to a misinterpretation of the preoperative imaging , and thus to an incomplete planning of the surgical procedure.
To correct this absence of radiological standardization, the investigating team has developed a reading grid for Computed Tomography (CT) aimed to facilitate preoperative planning of small bowel NET.
The main objective of the current study is to improve the semiotic description of the mesenteric and ganglionic tumoral extension of small intestine NET using a technically optimized imaging examination and a standardized reading grid in order to plan the best surgical procedure which would allow maintaining a minimal length of small intestine needed to yield a satisfying quality of life and nutritional status.
The secondary objective of this study is to evaluate the reproducibility of the standardized scanner's reading grid.
| Condition or disease | Intervention/treatment |
|---|---|
| Neuro-endocrine Tumors Small Intestine Cancer | Other: Standardized computerized tomography (CT) reading grid for preoperative planning |
| Study Type : | Observational |
| Actual Enrollment : | 47 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Assessment of an Optimized and Standardized Computerised Tomography (CT) Reading Grid for Preoperative Planning Improvement of Small Bowel Neuroendocrine Tumours (NET). |
| Actual Study Start Date : | March 31, 2019 |
| Estimated Primary Completion Date : | June 30, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Patients
Patients who have undergone pre-operated computerized tomography (CT) imaging for a subsequently operated Neuro-endocrine tumor (NET). Clinical data collected for each patients:
|
Other: Standardized computerized tomography (CT) reading grid for preoperative planning
Using the standardized reading grid, the following data will be collected:
The anonymized CT exam will be reviewed by an expert radiologist and a radiology resident from imaging department of the Hospital. |
- Standardization of a reading grid for PreOPerative Imaging of NeuroEndocrine Tumors [ Time Frame: 7 months ]Improve the semiological description of the mesenteric and ganglionic tumoral extension of small intestine NET using a technically optimized imaging technique with a standardized reading grid in order to plan the best surgical procedure which allows maintaining a minimal length of small intestine needed to a satisfying quality of life and nutritional status.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients with small intestine neuro-endocrine tumors (NET) operated in the digestive surgical service of the University Edouard Herriot hospital of Lyon (Pr. Gilles Poncet) between the 1st of January 2014 and the 31st of March 2019,
- Having done a preoperative thoraco-abdomino-pelvic scanner with arterial and portal sequences.
- Scanner imaging, operative report and anatomo-pathological report available
Exclusion Criteria:
- no Computerized Tomography (CT) images available
| France | |
| Hôpital Edouard Herriot | |
| Lyon, France, 69437 | |
| Principal Investigator: | Romain L'Huillier | Hospices Civils de Lyon |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 20, 2019 | ||||
| First Posted Date | May 21, 2019 | ||||
| Last Update Posted Date | May 28, 2019 | ||||
| Actual Study Start Date | March 31, 2019 | ||||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Standardization of a reading grid for PreOPerative Imaging of NeuroEndocrine Tumors [ Time Frame: 7 months ] Improve the semiological description of the mesenteric and ganglionic tumoral extension of small intestine NET using a technically optimized imaging technique with a standardized reading grid in order to plan the best surgical procedure which allows maintaining a minimal length of small intestine needed to a satisfying quality of life and nutritional status.
|
||||
| Original Primary Outcome Measures |
Computerized tomography (CT) optimized standard reading grid for PreOPerative Imaging of NeuroEndocrine Tumors [ Time Frame: 7 months ] Tumoral extension in small intestine neuro-endocrine tumors (NET) using a technically optimized standard computerized tomography (CT) reading grid in order to plan the best surgical gesture which would allow maintaining a minimal length of small intestine needed to a satisfying quality of life and nutritional status.
|
||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | PreOPerative Imaging of NeuroEndocrine Tumors | ||||
| Official Title | Assessment of an Optimized and Standardized Computerised Tomography (CT) Reading Grid for Preoperative Planning Improvement of Small Bowel Neuroendocrine Tumours (NET). | ||||
| Brief Summary |
Neuro-endocrine tumours (NET) are the most frequent tumours of the small intestine. In spite of their small size, these tumours have the particularity of forming mesenteric metastasis and ganglionic secondary lesions along the superior mesenteric axis, which is in close proximity to the superior mesenteric artery (SMA). Surgery is the only curative treatment. The complete resection being a factor for good patient prognosis, risks of subsequent local complications (occlusion, bleeding) must be discussed. The limiting factor for resectability is arterial vascular invasion considering the risk of postoperative small bowel syndrome. At the moment, the choice of imaging examination and its protocol is not standardized, nor the description of the tumoral mesenteric and ganglionic extension, especially the criteria defining a lymph node as lymphadenopathy. In addition, the complexity of SMA's anatomy and the absence of criteria for arterial invasion defining arterial invasion may lead to a misinterpretation of the preoperative imaging , and thus to an incomplete planning of the surgical procedure. To correct this absence of radiological standardization, the investigating team has developed a reading grid for Computed Tomography (CT) aimed to facilitate preoperative planning of small bowel NET. The main objective of the current study is to improve the semiotic description of the mesenteric and ganglionic tumoral extension of small intestine NET using a technically optimized imaging examination and a standardized reading grid in order to plan the best surgical procedure which would allow maintaining a minimal length of small intestine needed to yield a satisfying quality of life and nutritional status. The secondary objective of this study is to evaluate the reproducibility of the standardized scanner's reading grid. |
||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Male and female patients at least 18 years old with small intestine neuro-endocrine tumors (NET) | ||||
| Condition |
|
||||
| Intervention | Other: Standardized computerized tomography (CT) reading grid for preoperative planning
Using the standardized reading grid, the following data will be collected:
The anonymized CT exam will be reviewed by an expert radiologist and a radiology resident from imaging department of the Hospital. |
||||
| Study Groups/Cohorts | Patients
Patients who have undergone pre-operated computerized tomography (CT) imaging for a subsequently operated Neuro-endocrine tumor (NET). Clinical data collected for each patients:
Intervention: Other: Standardized computerized tomography (CT) reading grid for preoperative planning
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Actual Enrollment |
47 | ||||
| Original Actual Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2019 | ||||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03958188 | ||||
| Other Study ID Numbers | POPINET | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Hospices Civils de Lyon | ||||
| Study Sponsor | Hospices Civils de Lyon | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
||||
| PRS Account | Hospices Civils de Lyon | ||||
| Verification Date | May 2019 | ||||
