Outcomes of Endoscopically Resected High-risk Mucosal and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus

NCT04818476 | Unknown

• 1 other identifier: x
• Study Type: observational
• Target: 1,000
• Locations: 7 countries
• Sites: 16

Brief Summary

The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection.

Conditions

Barrett Esophagus; Adenocarcinoma Esophagus; Submucosal Esophageal Adenocarcinoma; High-risk Mucosal Esophageal Adenocarcinoma

Keywords

Barrett Esophagus; Submucosal esophageal adenocarcinoma; Endoscopic treatment; Endoscopic follow-up; High-risk mucosal esophageal adenocarcinoma

Outcome Measures

Primary Outcomes (4)

• lymph node metastasis rate

  Confirmed by cytology and/or histology by performing FNA during EUS or biopsies

  10 years

• distant metastasis rate

  Primary tumor of distant metastasis should be histopathologically evalueted by taking biopsies.

  10 years

• disease-specific mortality

  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.

  10 years

• overall mortality

  Overall mortality of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).

  10 years

Study Arms (3)

HR-T1a

Patients who weretreated by radical endoscopic resection for a high-risk mucosal EAC (HR-T1a N0M0)

Procedure: diagnostic endoscopic resection

LR-T1b

Patients who were treated by radical endoscopic resection for a low-risk submucosal EAC (LR-T1b N0M0)

Procedure: diagnostic endoscopic resection

HR-T1b

Patients who were treated by radical endoscopic resection for a high-risk submucosal EAC (HR-T1b N0M0)

Procedure: diagnostic endoscopic resection

Interventions

diagnostic endoscopic resection PROCEDURE

diagnostic endoscopic resection

HR-T1a; HR-T1b; LR-T1b

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a diagnostic ER for Barrett's related HR T1a or T1b EAC in one of the participating centers, from 1/1/2008 up to the moment of data collection.

You may qualify if:

• Males or females, all ages
• Endoscopic resection of a histologically proven high risk T1a, low risk T1b EAC, or high risk T1b EAC
• Between 1/1/2008 and 1/1/2019
• Endoscopic resection and endoscopic FU (or other treatment after ER) have taken place in the participating center
• No written or oral refusal to use subject's data
• Objection against participation in this study

Sponsors & Collaborators

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

Study Sites (16)

Westmead hospital

Sydney, Australia

NOT YET RECRUITING

UZ Gasthuisberg

Leuven, Belgium

RECRUITING

CHU Nantes

Nantes, France

NOT YET RECRUITING

Universitätsklinikum Augsburg

Augsburg, Germany

NOT YET RECRUITING

EVK Duesseldorf

Düsseldorf, Germany

NOT YET RECRUITING

MRI TUM

Münich, Germany

NOT YET RECRUITING

Barmherzige Brüder Regensburg

Regensburg, Germany

NOT YET RECRUITING

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

COMPLETED

Catharina Hospital

Eindhoven, Netherlands

COMPLETED

University Medical Center Groningen

Groningen, Netherlands

COMPLETED

St. Antonius Hospital

Nieuwegein, Netherlands

COMPLETED

Erasmus MC - University Medical Center

Rotterdam, Netherlands

COMPLETED

Haga Medical Center

The Hague, Netherlands

COMPLETED

Isala Clinics

Zwolle, Netherlands

COMPLETED

Hirslanden private hospital group

Zurich, Switzerland

RECRUITING

University College London Hospital

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• R.E. Pouw, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Man Wai Chan, MD

CONTACT

(0)20 4442432; m.w.chan@amsterdamumc.nl

Wilda Rosmolen, MSc

CONTACT

(0)20 4442432; w.d.rosmolen@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastrointestinal Endoscopy

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: February 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); FR (1); NL (7); GB (1); CH (1); AU (1); BE (1)