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Endoscopic Resection Techniques for Esophageal Cancer (BEEPER Trial)

N/A
Recruiting
Led By Thomas Rösch, Prof. Dr.
Research Sponsored by Universitätsklinikum Hamburg-Eppendorf
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients to be treated for Barrett's esophagus by mucosal resection and following ablative therapy
Barrett's mucosal extension up to 10 cm maximum
Must not have
Barrett's esophagus > 10 cm
Lesions that would afford resection of more than 2/3rd of esophageal circumference
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 51 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two different ways of removing abnormal tissue from the esophagus, to see which is more effective and has fewer risks in the long term.

Who is the study for?
This trial is for patients with Barrett's esophagus needing mucosal resection and follow-up therapy, with lesions up to 10 cm. Participants must be able to comply with treatment and provide consent. It excludes those with serious illnesses, metastatic cancer, large or deep lesions, extensive Barrett's esophagus over 10 cm, or requiring more than two-thirds of the esophageal circumference resected.
What is being tested?
The study compares two techniques for removing abnormal tissue in Barrett's esophagus: Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD), both followed by ablative therapy. The goal is to evaluate their long-term effectiveness and safety.
What are the potential side effects?
Potential side effects from EMR and ESD may include bleeding, pain at the procedure site, risk of infection, tearing of the esophagus lining (perforation), and possible narrowing of the esophagus (stricture).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for treatment on my esophagus using resection and ablation.
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My Barrett's esophagus extends no more than 10 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My Barrett's esophagus is longer than 10 cm.
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My esophageal cancer can be surgically removed without taking out more than two-thirds of the esophagus.
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I am scheduled for a surgery that will remove tissue in a circular pattern.
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My Barrett's esophagus has returned or persisted after treatment.
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I have two or more Barrett's lesions with high-grade changes or early cancer, not removable in one procedure.
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I cannot undergo biopsies or surgeries due to a bleeding disorder or blood-thinning medication.
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I have a severe illness and cancer that has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~51 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 51 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Eradication rate of neoplastic Barrett's Esophagus
Eradication rate of neoplastic Barrett's Esophagus, initial therapy success
Secondary study objectives
Barrett Esophagus
Determination of differences in Barrett's esophagus subtypes: histologies
Determination of differences in Barrett's esophagus subtypes: patterns
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: EMRActive Control1 Intervention
Endoscopic mucosal resection
Group II: ESDActive Control1 Intervention
Endoscopic submucosal dissection

Find a Location

Who is running the clinical trial?

Universitätsklinikum Hamburg-EppendorfLead Sponsor
481 Previous Clinical Trials
2,076,739 Total Patients Enrolled
Thomas Rösch, Prof. Dr.Principal InvestigatorPh D, Director, Head of department
9 Previous Clinical Trials
2,995 Total Patients Enrolled

Media Library

Endoscopic mucosal resection Clinical Trial Eligibility Overview. Trial Name: NCT03427346 — N/A
Esophageal Neoplasm Research Study Groups: EMR, ESD
Esophageal Neoplasm Clinical Trial 2023: Endoscopic mucosal resection Highlights & Side Effects. Trial Name: NCT03427346 — N/A
Endoscopic mucosal resection 2023 Treatment Timeline for Medical Study. Trial Name: NCT03427346 — N/A
~38 spots leftby Oct 2025
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