PALASS: PAncreas Borderline and Locally Advanced Snapshot Study
Study Details
Study Description
Brief Summary
The project's objective is to carry out prospectively, in France, for one year, a descriptive registry study in the management of patients with borderline or locally advanced pancreatic adenocarcinoma, and to collect both the patient's demographic characteristics, but also the therapeutic regimens applied, the types of surgeries performed and the outcome of the patients after surgery, and at three months of follow up (preoperative data, complications's post surgery, quality of the resection, etc.)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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Multicenter, observational prospective study over one year in France in patients with borderline or locally advanced pancreatic adenocarcinoma operated between September 2022 and August 2023.
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Patients will be screened by the pancreatic's surgeons practicing in a reference centers during preoperative surgical consultations (V1),
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The patient's non-objection will be sollected,
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The end of follow-up's patient will take place during the post-operative consultation approximately 3 months after surgery (V3)
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Between V1 and V3, preoperative data (demography, history, tumor characteristics, neoadjuvant treatments performed, tumor response), operative, intraoperative, pathological and postoperative data will be collected via a e-CRF " the REDCAP software".
Study Design
Outcome Measures
Primary Outcome Measures
- The main study's objective is to definite the effective rate of adjuvant chemotherapy performed after surgery (at the 3-month post operatively), which is essential marker recognized as improving overall survival. [during 1 year]
Evaluation of the rate of adjuvant chemotherapy performed after surgery (at the 3-month post operatively)
Secondary Outcome Measures
- The secondary objective of the study is to know, in patients operated for pancreatic adenocarcinoma, the rate of postoperative complications, the rate of the postoperative morbidity and mortality, and the quality of the resection. [during 1 year]
the secondary objective will be definited by evaluation of the rate of postoperative complications, the rate of postoperative morbidity and mortality and the quality of the resection (R0)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Any patient over the age of 18, operated on for pancreatic adenocarcinoma, borderline or locally advanced, between September 2022 and August 2023, in France
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Diagnosis of pancreatic adenocarcinoma:
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either after cytopuncture with anatomopathological result confirming the diagnosis,
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or with strong suspicion on the combined criterias : clinical, biological and morphological criterion (according to INCa 2019 and NCCN recommendations ) in the event of absence of anatomopathological documentation (failure of several fine needle punctures (maximum 3)/or non-contributory anatomopathological examinations),
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Borderline or locally advanced character depending on the presence of a contact of the tumor with nearby vessels and defined by morphological examination (scanner +/- MRI). These criteria are defined by the NCCN Guidelines for Pancreatic Adenocarcinoma V.1.2021, international reference
Exclusion Criteria:
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Patient under juridic protected or subject to any measure of legal protection,
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Patients not operated on for their pancreatic adenocarcinoma,
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Adenocarcinoma of the pancreas operable immediately on diagnosis,
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Metastatic pancreatic adenocarcinoma from the outset on diagnosis,
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Patient without pancreatic adenocarcinoma after histological examination (in the case where the pancreatic lesion was operated on for strong suspicion of pancreatic adenocarcinoma on the combined clinical, biological and morphological criterion (according to INCa 2019 and NCCN recommendations, but that the lesion on definitive pathological examination is not a pancreatic adenocarcinoma)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Amiens | Amiens | France | ||
| 2 | CHU Besançon | Besançon | France | ||
| 3 | CHU Bordeaux | Bordeaux | France | ||
| 4 | CHU clermont-ferrand | Clermont-Ferrand | France | 63000 | |
| 5 | CHU Dijon | Dijon | France | ||
| 6 | CHU Lille | Lille | France | ||
| 7 | Hospices Civils de Lyon | Lyon | France | ||
| 8 | APHM | Marseille | France | ||
| 9 | Institut Paoli-Calmettes d'Unicancer | Marseille | France | ||
| 10 | CHU Montpellier | Montpellier | France | ||
| 11 | CHU Nancy | Nancy | France | ||
| 12 | CHU Nantes | Nantes | France | ||
| 13 | CHU Nice | Nice | France | ||
| 14 | APHP Hopital Beaujon | Paris | France | ||
| 15 | APHP Hopital Cochin | Paris | France | ||
| 16 | APHP Hopital de la Pitié-Salpétrière | Paris | France | ||
| 17 | APHP Hopital Paul Brousse | Paris | France | ||
| 18 | CHU Reims | Reims | France | ||
| 19 | CHU Rennes | Rennes | France | ||
| 20 | CHU Rouen | Rouen | France | ||
| 21 | CHU Strasbourg | Strasbourg | France | ||
| 22 | CHU Toulouse | Toulouse | France | ||
| 23 | CHU Tours | Tours | France |
Sponsors and Collaborators
- University Hospital, Clermont-Ferrand
Investigators
- Study Director: Johan Gagniere, University Hospital, Clermont-Ferrand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022 GAGNIERE PALASS