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Risk of GAstric Adenocarcinoma After Cephalic Duodenopancreatectomy (RAGAD)

Primary Purpose

Cephalic Duodenopancreatectomy 10 or More Years Ago

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high digestive endoscopy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cephalic Duodenopancreatectomy 10 or More Years Ago

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  1. Inclusion Criteria:

    Criteria for inclusion in the cohort:

    • 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

    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 in the cohort:

- 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 prior to inclusion in the "endoscopy" group (before or after CPD)
  • Pregnant or lactating woman
  • Patient under guardianship
  • Patient with contraindications to local anesthetics and propofol

Sites / Locations

  • LORENZORecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

with endoscopy

without endoscopy

Arm Description

high digestive endoscopy

no endoscopy

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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)
prevalence of low grade dysplasia in patients who performed the endoscopy
proportion of patients with low grade dysplasia
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)
prevalence of intestinal metaplasi in patients who performed the endoscopy
proportion of patients with intestinal metaplasia.
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)
prevalence of gastric cancer or high grade dysplasia in cohort of patients
proportion of patients with gastric cancer or high grade dysplasia
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)
prevalence of low grade dysplasia in cohort of patients
proportion of patients with intestinal metaplasia
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)
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.
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.

Full Information

First Posted
May 24, 2019
Last Updated
May 12, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03991065
Brief Title
Risk of GAstric Adenocarcinoma After Cephalic Duodenopancreatectomy
Acronym
RAGAD
Official Title
Risk of GAstric Adenocarcinoma After Cephalic Duodenopancreatectomy : RAGAD Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cephalic Duodenopancreatectomy 10 or More Years Ago

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Of the patients included in the cohort, some will be eligible to perform the endoscopy added for research
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
with endoscopy
Arm Type
Experimental
Arm Description
high digestive endoscopy
Arm Title
without endoscopy
Arm Type
No Intervention
Arm Description
no endoscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
high digestive endoscopy
Intervention Description
high digestive endoscopy with biopsies performed according to the sydney protocol
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
7 months after inclusion
Secondary Outcome Measure Information:
Title
Prevalence of gastric cancer or high grade dysplasia in patients who performed the endoscopy
Description
the proportion of patients with gastric cancer or high grade dysplasia among patients in the endoscopic study
Time Frame
7 months after inclusion
Title
Low-grade dysplasia incidence rate in patients who performed the endoscopy
Description
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)
Time Frame
7 months after inclusion
Title
prevalence of low grade dysplasia in patients who performed the endoscopy
Description
proportion of patients with low grade dysplasia
Time Frame
7 months after inclusion
Title
Incidence rate of intestinal metaplasia in patients who performed the endoscopy
Description
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)
Time Frame
7 months after inclusion
Title
prevalence of intestinal metaplasi in patients who performed the endoscopy
Description
proportion of patients with intestinal metaplasia.
Time Frame
7 months after inclusion
Title
incidence rate of gastric cancer or high grade dysplasia in cohort of patients
Description
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)
Time Frame
inclusion
Title
prevalence of gastric cancer or high grade dysplasia in cohort of patients
Description
proportion of patients with gastric cancer or high grade dysplasia
Time Frame
inclusion
Title
incidence rate of low-grade dysplasia in cohort of patients
Description
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)
Time Frame
inclusion
Title
prevalence of low grade dysplasia in cohort of patients
Description
proportion of patients with intestinal metaplasia
Time Frame
inclusion
Title
incidence rate of intestinal metaplasia in cohort of patients
Description
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)
Time Frame
inclusion
Title
Prevalence of intestinal metaplasia, in cohort of patients
Description
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.
Time Frame
inclusion
Title
Factors associated with low-grade dysplasia or intestinal metaplasia in cohort of patients
Description
occurence of factors thought to be associated, as well as those of gastric cancer or high-grade dysplasia.
Time Frame
inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Lorenzo
Phone
140875328
Ext
33
Email
diane.lorenzo@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
philippe levy
Phone
140875328
Ext
33
Email
philippe.levy@aphp.fr
Facility Information:
Facility Name
LORENZO
City
Clichy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DIANE LORENZO
Email
diane.lorenzo@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Risk of GAstric Adenocarcinoma After Cephalic Duodenopancreatectomy

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