Cephalic Duodenopancreatectomy 10 or More Years Ago Clinical Trial
— RAGADOfficial title:
Risk of GAstric Adenocarcinoma After Cephalic Duodenopancreatectomy : RAGAD Study
In view of the similarities of the surgical set-ups of partial gastrectomies and cephalic duodenopancreatectomies, and the increased risk of gastric cancer after early partial gastrectomy, it is possible that the former pancreatic cephalic duodenopancreatectomy pancreaticoduodenectomy (CPD) is also associated with the occurrence of stomach cancer. The investigators expect a high rate of cancer and high grade dysplasia in these patients based on literature data and available data on gastric cancer after partial gastrectomy. Participants with lesions to be discovered will benefit from earlier medical management of less advanced tumor lesions, with improved prognosis. The primary objective of this study is to evaluate the incidence of gastric cancer or high grade dysplasia in patients with old CPP CPD (10 years or older) and who performed the endoscopy protocol. The cohort will consist of all eligible patients identified from pathology registries and PMSI data from participating centers (patients living 10 years after CPDP, with no previous history of gastric cancer before entering the cohort). Entry into the cohort (beginning of exposure) will be 10 years after CPD. If a gastric cancer has been diagnosed previously at the beginning of the current study (2019) with histological documentation present in the medical file, no new endoscopy will be performed and the patient will be considered as a "new case" on the date of histological diagnosis of cancer. Of the patients included in the cohort, some will be eligible to perform the endoscopy added for research. This group will be the sample in which the primary endpoint will be measured. 1. Recruitment of patients with cephalad cephalic duodenopancreatectomy 10 or more years ago 2. Per patient (in the group with endoscopies): - Inclusion consultation with patient consent collection - Anesthesia consultation - Upper gastrointestinal endoscopy and biopsy - Follow-up consultation to report the results to the patient and possibly organize a support (announcement device complies with HAS recommendations). For patients in the cohort not included in the endoscopy study, the data collection will be retrospective only (no specific patient consultation for research and no endoscopy review added for this research). 3. Data analysis: primary endpoints (incidence rate of high grade dysplasia and gastric cancer) and secondary endpoints 700 to 800 patients will be included in the entire cohort and 164 patients in the group with endoscopy. 7 centers in Ile de France participate. - duration of inclusion: 36 months - duration of participation (treatment + follow-up): schedule of the visit of anesthesia (5.5 months max), endoscopy programming (1 month max) + the day of the exam + 4 weeks for the results of the exam: 8 months maximum - total duration: 44 months
| Status | Recruiting |
| Enrollment | 800 |
| Est. completion date | March 31, 2025 |
| Est. primary completion date | October 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 1. Inclusion Criteria: Criteria for inclusion for patient without endoscopy for research: - Patient living 10 years after a CPD performed for a benign or malignant condition in one of the participating centers - Age = 18 years at the time of entry into the cohort (10 years after CPD) - Non opposition to the use of data - patient with endoscopy realised 10 years after CPD and before the participation of the study Inclusion criteria to have endoscopy : - Patient living 10 years after a CPP performed for a benign or malignant condition in one of the participating centers Age = 18 years of age for inclusion in the "endoscopy" group - Patient with low or medium anesthetic risk (ASA 1, ASA 2, ASA 3) - Patient who does not have a genetic or acquired haemostasis disorder preventing the performance of gastric biopsies - Possibility of stopping treatment with anticoagulant or clopidogrel or ticagrelor if necessary (see Appendix 1: Management of anticoagulants-antiaggregants in upper gastrointestinal endoscopy requiring gastric biopsies (according to SFED, ESGE recommendation)) (44) - Patient affiliated to a social security scheme - Informed and signed consent of the patient obtained 2. No inclusion Criteria: Criteria for non-inclusion for all patient: - Personal history of gastric cancer prior to inclusion in the cohort (before CPD or 10 years after CPD) Criteria for non-inclusion in endoscopy'group: - Personal history of gastric cancer - Pregnant or lactating woman - Patient under guardianship - Patient with contraindications to local anesthetics and propofol |
| Country | Name | City | State |
|---|---|---|---|
| France | LORENZO | Clichy |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the incidence rate of gastric cancer or high grade dysplasia in patients who had CPD 10 or more years ago in the sample of patients who performed the protocol endoscopy | the ratio of the number of new cases of gastric cancer or high grade dysplasia (diagnosed at endoscopy with biopsies) divided by the sum of person-times at risk of developing the disease (expressed in person-years). | 7 months after inclusion | |
| Secondary | Prevalence of gastric cancer or high grade dysplasia in patients who performed the endoscopy | the proportion of patients with gastric cancer or high grade dysplasia among patients in the endoscopic study | 7 months after inclusion | |
| Secondary | Low-grade dysplasia incidence rate in patients who performed the endoscopy | ratio of the number of new cases of low-grade dysplasia (diagnosed at endoscopy with biopsies) divided by the sum of person-times at risk of developing the disease ( expressed in person-years) | 7 months after inclusion | |
| Secondary | prevalence of low grade dysplasia in patients who performed the endoscopy | proportion of patients with low grade dysplasia | 7 months after inclusion | |
| Secondary | Incidence rate of intestinal metaplasia in patients who performed the endoscopy | ratio of the number of new cases of intestinal metaplasia (diagnosed at endoscopy with biopsies) divided by the sum of person-times at risk of developing the disease (expressed in terms of years) | 7 months after inclusion | |
| Secondary | prevalence of intestinal metaplasi in patients who performed the endoscopy | proportion of patients with intestinal metaplasia. | 7 months after inclusion | |
| Secondary | incidence rate of gastric cancer or high grade dysplasia in cohort of patients | ratio of the number of new cases of low grade dysplasia (histological evidence in the medical file or diagnosed at the endoscopy provided for in the protocol) divided by the sum of person-times at risk of developing the disease (expressed in person-years) | inclusion | |
| Secondary | prevalence of gastric cancer or high grade dysplasia in cohort of patients | proportion of patients with gastric cancer or high grade dysplasia | inclusion | |
| Secondary | incidence rate of low-grade dysplasia in cohort of patients | the ratio of the number of new cases of low-grade dysplasia (histological evidence in the medical file or diagnosed at the protocol endoscopy) divided by the sum of the time at risk of developing the disease (expressed in person-years) | inclusion | |
| Secondary | prevalence of low grade dysplasia in cohort of patients | proportion of patients with intestinal metaplasia | inclusion | |
| Secondary | incidence rate of intestinal metaplasia in cohort of patients | ratio of the number of new cases of low grade dysplasia (histological evidence in the medical file or diagnosed at the endoscopy provided for in the protocol) divided by the sum of the person-times at risk of developing the disease (expressed in person-years) | inclusion | |
| Secondary | Prevalence of intestinal metaplasia, in cohort of patients | proportion of patients with intestinal metaplasia factors associated with gastric cancer or severe dysplasia. The factors thought to be associated are: family history of gastric cancer, active smoking, presence of Helicobacter pylori, digestive symptoms, pancreaticogastric anastomosis. | inclusion | |
| Secondary | Factors associated with low-grade dysplasia or intestinal metaplasia in cohort of patients | occurence of factors thought to be associated, as well as those of gastric cancer or high-grade dysplasia. | inclusion |