NCT03991065: RAGAD

Risk of GAstric Adenocarcinoma After Cephalic Duodenopancreatectomy

Status unknown NA Last updated 15 May 2023

What this trial tests

NA trial testing high digestive endoscopy in Cephalic Duodenopancreatectomy 10 or More Years Ago in 800 participants. Status unknown.

Timeline

16 January 2020

Primary endpoint
1 October 2024

31 March 2025

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	800
Start date	16 January 2020
Primary completion	1 October 2024
Estimated completion	31 March 2025
Sites	1 location across France

Drugs / interventions tested

• high digestive endoscopy

Conditions studied

• Cephalic Duodenopancreatectomy 10 or More Years Ago — all drugs for Cephalic Duodenopancreatectomy 10 or More Years Ago →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Cephalic Duodenopancreatectomy 10 or More Years Ago. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.