Clinical trial NCT03991065: Risk of GAstric Adenocarcinoma After Cephalic Duodenopancreatectomy
Official title: Risk of GAstric Adenocarcinoma After Cephalic Duodenopancreatectomy : RAGAD Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cephalic Duodenopancreatectomy 10 or More Years Ago
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Of the patients included in the cohort, some will be eligible to perform the endoscopy added for research
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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 (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 investigators results will provide an argument for conducting larger analytical studies and will also provide useful information for the design of these studies. These studies will eventually identify a gastric cancer screening strategy among patients with previous CPDP. Screening programs in groups at higher risk of gastric cancer among patients with CPDP could provide significant benefits in terms of gastric cancer mortality and quality of life, as well as medico-economic positive for the health care system.

The primary objective of this study is to evaluate the incidence of gastric cancer or high grade dysplasia in patients with old CPDP (10 years or older) and who performed the endoscopy protocol.

The primary endpoint is the incidence rate of gastric cancer or high grade dysplasia in patients who had CPDP 10 years or more ago.

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. The collection of data will be retrospective for these patients.

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 7 months after inclusion
Secondary outcomes:
measure: Prevalence of gastric cancer or high grade dysplasia in patients who performed the endoscopy
timeFrame: 7 months after inclusion
measure: Low-grade dysplasia incidence rate in patients who performed the endoscopy
timeFrame: 7 months after inclusion
measure: prevalence of low grade dysplasia in patients who performed the endoscopy
timeFrame: 7 months after inclusion
measure: Incidence rate of intestinal metaplasia in patients who performed the endoscopy
timeFrame: 7 months after inclusion
measure: prevalence of intestinal metaplasi in patients who performed the endoscopy
timeFrame: 7 months after inclusion
measure: incidence rate of gastric cancer or high grade dysplasia in cohort of patients
timeFrame: inclusion
measure: prevalence of gastric cancer or high grade dysplasia in cohort of patients
timeFrame: inclusion
measure: incidence rate of low-grade dysplasia in cohort of patients
timeFrame: inclusion
measure: prevalence of low grade dysplasia in cohort of patients
timeFrame: inclusion
measure: incidence rate of intestinal metaplasia in cohort of patients
timeFrame: inclusion
measure: Prevalence of intestinal metaplasia, in cohort of patients
timeFrame: inclusion
measure: Factors associated with low-grade dysplasia or intestinal metaplasia in cohort of patients
timeFrame: inclusion
Other outcomes:
Locations:
city: Clichy
country: France
facility: LORENZO
Study officials:
References: