Risk of GAstric Adenocarcinoma After Cephalic Duodenopancreatectomy (RAGAD)

May 12, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: with endoscopy
high digestive endoscopy
Diagnostic test: high digestive endoscopy
high digestive endoscopy with biopsies performed according to the sydney protocol
No Intervention: without endoscopy
no endoscopy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 7 months after inclusion
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of gastric cancer or high grade dysplasia in patients who performed the endoscopy
Time Frame: 7 months after inclusion
the proportion of patients with gastric cancer or high grade dysplasia among patients in the endoscopic study
7 months after inclusion
Low-grade dysplasia incidence rate in patients who performed the endoscopy
Time Frame: 7 months after inclusion
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
prevalence of low grade dysplasia in patients who performed the endoscopy
Time Frame: 7 months after inclusion
proportion of patients with low grade dysplasia
7 months after inclusion
Incidence rate of intestinal metaplasia in patients who performed the endoscopy
Time Frame: 7 months after inclusion
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
prevalence of intestinal metaplasi in patients who performed the endoscopy
Time Frame: 7 months after inclusion
proportion of patients with intestinal metaplasia.
7 months after inclusion
incidence rate of gastric cancer or high grade dysplasia in cohort of patients
Time Frame: inclusion
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
prevalence of gastric cancer or high grade dysplasia in cohort of patients
Time Frame: inclusion
proportion of patients with gastric cancer or high grade dysplasia
inclusion
incidence rate of low-grade dysplasia in cohort of patients
Time Frame: inclusion
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
prevalence of low grade dysplasia in cohort of patients
Time Frame: inclusion
proportion of patients with intestinal metaplasia
inclusion
incidence rate of intestinal metaplasia in cohort of patients
Time Frame: inclusion
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
Prevalence of intestinal metaplasia, in cohort of patients
Time Frame: inclusion
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
Factors associated with low-grade dysplasia or intestinal metaplasia in cohort of patients
Time Frame: inclusion
occurence of factors thought to be associated, as well as those of gastric cancer or high-grade dysplasia.
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P180302J

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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