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JOURNAL ONKOLOGIE – STUDIE

Prospective Endoscopic Follow-up of Patients With Submucosal Esophageal Adenocarcinoma (The PREFER Trial)

Rekrutierend

NCT-Nummer:
NCT03222635

Studienbeginn:
Juli 2017

Letztes Update:
14.01.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Adenocarcinoma, Barrett Esophagus, Esophageal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborator:
-

Studienleiter

J. J. Bergman, MD, PhD
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
R. E. Pouw, MD, PhD
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Kontakt

Studienlocations (3 von 18)

Academic Medical Center
Amsterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
E. Nieuwenhuis, MD
Phone: +31205661613
E-Mail: e.a.nieuwenhuis@amsterdamumc.nl

W. D. Rosmolen, Master
Phone: +31205663252
E-Mail: w.d.rosmolen@amsterdamumc.nl
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Traditionally, the risk of lymph node metastasis associated with submucosal EAC was

considered too high to offer patients endoscopic follow-up. Only in elderly patients with

comorbidity, more often an endoscopic protocol is selected. However, the risk of lymph node

metastasis associated with submucosal EAC is mainly based on surgical series. Recently a

number of studies, which included patients treated endoscopically, were published indicating

that the risk of lymph node metastasis may be much lower than generally assumed.Therefore, a

less invasive and organ preserving approach may not only be an option in the frail and

elderly, but for all patients with submucosal EAC's.

Yet, no data exists on the risk of lymph node metastasis in high risk T1a EAC. The risk is

assumed to be lower than for EACs invading into the submucosal layer. However, a recent

(unpublished) retrospective analysis from our own research group shows that this risk may be

higher than previously assumed. In this nationwide retrospective study, we analysed lymph

node metastasis rates and EAC related mortality rates concerning patients with high risk T1a,

low risk T1b or high risk T1b EAC who received endoscopic treatment. The study was performed

in 9 Barrett Expert Centers in the Netherlands (2008-2019). 120 patients were included in the

analysis, and results showed the highest lymph node metastasis risk in the high risk T1a

patient group Aim of this multicenter study is to prospectively evaluate the safety of

endoscopic follow-up in patients treated by endoscopic resection for submucosal (T1bN0M0)

EAC.

High-resolution upper endoscopy with white-light endoscopy and narrow-band imaging

supplemented with an EUS are performed every three months during the first two years after

ER. After 1 year, a CT-thorax/abdomen will be performed to check for distant metastasis.

During the third and fourth year of follow-up, EUS and upper endoscopy are performed every

six months. From the fifth year on, EUS and upper endoscopy are performed annually.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, revised

by a panel of expert gastrointestinal (GI) pathologists.

- Signed informed consent.

Exclusion Criteria:

- Prior history of high-risk mucosal or ≥T1sm.

- Synchronous esophageal squamous cell carcinoma.

- Suspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the

neck or CT-thorax-abdomen performed six weeks after ER during baseline measurement.

- Tumor-positive deep resection margin (R1) in ER specimen.

- Patients unable to give signed informed consent.

Studien-Rationale

Primary outcome:

1. 5-year disease-specific mortality/survival (descriptive statistics in SPSS, percentages, survival analysis) (Time Frame - 5 years):
Disease specific mortality is decribed as mortality directly linked to the esophageal adenocarcinoma (i.e., metastasized EAC, metastasized disease with a simultaneously primary cancer present and it cannot be ruled out (based on histology) that the metastases are related to the other primary cancer, death due to complications of the endoscopic procedure, death due to complications after surgery or CRT, no clear cause of death in patients who have metastases or untreated local recurrence). If patients are diagnosed with distant metastases, and subsequently die of a non-tumor related cause, patients will still be documented as tumor-related death. Will be measured in number of patients and percentages. Survival analysis using Kaplan Meier will be performed.

2. Overall survival (descriptive statistics in SPSS, percentages, survival analysis) (Time Frame - 5 years):
Overall survival of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).

Secondary outcome:

1. Lymph node metastasis, confirmed by cytology and/or histology (descriptive statistics in SPSS, number of patients (%)) (Time Frame - 5 years):
Confirmed by cytology and/or histology by performing FNA during EUS or biopsies.

2. Local recurrence eligible for endoscopic therapy (descriptive statistics in SPSS, number of patients (%)) (Time Frame - 5 years):
In case a local recurrence is found during FU endoscopy, histopathology have to show if it is recurrent cancer.

3. Local recurrence requiring surgical therapy (descriptive statistics in SPSS, number of patients (%)) (Time Frame - 5 years):
In case a local cancer recurrence is not amendable for endoscopic re-treatment, for example due to extensive disease or fibrosis, a patient will be referred for surgery if possible.

4. Distant metastasis, histologically proven (descriptive statistics in SPSS, number of patients (%)) (Time Frame - 5 years):
Primary tumor of distant metastasis should be histopathologically evalueted by taking biopsies.

5. Quality of life during follow-up endoscopies (questionnaires) (Time Frame - 5 years):
Quality of life is assessed by using questionnaires on set time points during the whole study.

Geprüfte Regime

  • Endoscopic follow-up:
    Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds

Quelle: ClinicalTrials.gov


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