Viewing Study NCT03222635



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Last Modification Date: 2024-10-26 @ 12:28 PM
Study NCT ID: NCT03222635
Status: RECRUITING
Last Update Posted: 2024-04-29
First Post: 2017-07-17

Brief Title: Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma
Sponsor: Amsterdam UMC
Organization: Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA

Study Overview

Official Title: Endoscopic Management of Patients With High Risk T1a and T1b N0M0 Esophageal Adenocarcinoma a Prospective Multicenter Registry
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PREFER
Brief Summary: Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection ER for submucosal or high-risk mucosal esophageal adenocarcinoma T1bN0M0 or HR T1aN0M0 EAC
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 1-5 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 EACs

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 retrospective analysis from our own research group shows that this risk may be higher than previously assumed 6 In this nationwide retrospective study we analyzed 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 and high risk mucosal T1aN0M0 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-thoraxabdomen 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None