Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection (BEEPER)

June 27, 2023 updated by: Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

Prospektiv-randomisierter Vergleich Von En-bloc- Versus Piecemeal-Resektion Von Barrett Neoplasien Des Ösophagus Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection

The study will compare EMR versus ESD technique (both combined with subsequent ablative therapy) of mucosal resection in Barrett's esophagus with regard to efficacy and risk in a long term setting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For Barrett's Esophagus neoplasia of at least LGIN up to early adenocarcinoma, the aim is to debulk or completely treat polypoid dysplastic or malignant lesions in Barrett's esophagus. The Endoscopic Mucosal Resection EMR has been established to be a less invasive, safe, and effective nonsurgical therapy. The most commonly employed modalities of EMR include snare resection with and without prior submucosal injection of fluid, and resection using a cap. Since resection of larger areas can only be done piece - by- piece this kind or resection is also called piecemeal resection or piecemeal EMR. Meanwhile, another endoscopic resection has been developed called Endoscopic Submucosal Dissection ESD.It enables complete resection of neoplasms that were impossible to resect en bloc by EMR. After circumferential cutting of the surrounding mucosa of the lesion, fluid is injected into the submucosa to elevate the lesion from the muscle layer, and subsequently the connective tissue beneath the lesion is dissected. As a basic principle on histopathological and oncological terms, the en bloc resection is to be preferred since resection integrity can be evaluated much more securely. However, complexity of this kind of resection technique as well as complication rates can be different and sometimes higher than with EMR. Current approach treating Barrett's esophagus is to eradicate both neoplastic as well as pre neoplastic or non neoplastic Barrett mucosa in order to lower the relapse risk. Current treatment standard is to combine resection of visible neoplastic areas with subsequent thermo-ablation such as RFA or APC, so this approach will also be the basis of the present study. Since RFA has the largest volume of data screened it shall be the preferred method of ablation in this study.In total, data situation ist inconsistent. Short- and Long term of EMR is excellent in centres(Pech et al, Gastroenterology 2014) whereas ESD achieved only suboptimal outcomes in tree minor western studies (Neuhaus et al. Endoscopy 2012, Höbel et al., Surg Endosc 2015, Chevaux et al. Endoscopy 2015). One randomised study published in 2016 (Terheggen et al. Gut 2016) had a higher rate of R0 resections with ESD on 40 patients but no difference in complete remissions in combination with RFA. Although, this study was not empowered sufficientliy, and also showed a higher complication rate on ESD . At present no randomised study data are availale to allow statements about long term developments, so we will set up this current randomised study. We will compare data with regard to efficacy (histological completeness and relapse rates), as well as risks, e.g. perforations and strictures or stenosis by scarring.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
407

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Thomas Rösch, Prof. Dr.
  • Phone Number: 50098 + 49 40 7410
  • Email: t.roesch@uke.de

Study Contact Backup

  • Name: Hanno Ehlken, Dr.
  • Phone Number: 18232 + 49 40 7410
  • Email: h.ehlken@uke.de

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Sub-Investigator:
          • Katharina Zimmermann-Fraedrich, Dr.
        • Sub-Investigator:
          • Guido Schachschal, PD Dr.
        • Sub-Investigator:
          • Philip Dautel, Dr.
        • Contact:
          • Thomas Rösch, Prof. Dr.
          • Phone Number: 50098 + 49 40 7410
          • Email: t.roesch@uke.de
        • Contact:
        • Sub-Investigator:
          • Yuki B. Werner, Dr.
        • Sub-Investigator:
          • Hanno Ehlken, PD Dr.
        • Sub-Investigator:
          • Jocelyn de Heer, Dr.
        • Principal Investigator:
          • Thomas Rösch, Prof. Dr.
        • Sub-Investigator:
          • Karsten Ohlhoff, Dr.
  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ji Young Bang, MD MPH
        • Sub-Investigator:
          • Shyam Varadarajulu, MD
        • Sub-Investigator:
          • Robert Hawes, MD
        • Sub-Investigator:
          • Udayakumar Navaneethan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients to be treated for Barrett's esophagus by mucosal resection and following ablative therapy
  • Barrett's mucosal extension up to 10 cm maximum.
  • patient's ability for compliance to therapy
  • signed Informed Consent

Exclusion Criteria:

  • any lesion questionable to be resectable by mucosectomy, e.g. bulky lesions ≥10 mm in endoscopy und endosonography, suspected deep submucosal infiltration, ulcers, suspected or by FNA confirmed lymph node infiltration
  • Barrett's esophagus > 10 cm
  • lesions that would afford resection of more than 2/3rd of esophagal circumference
  • two or more single Barrett's lesions with bulky HGIN or early cancer histology, not to be resectable in one half of esophageal circumference
  • planned circumferencial resections
  • very serious general illness and metastatic carcinoma
  • coagulation disorder or anticoagulants that make biopsies and resections impossible
  • American Society of Anesthesiologists (ASA) status > III
  • pregnancy and lactation
  • remainders or recurrences after therapeutic history of Barrett's espohagus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: EMR
Endoscopic mucosal resection
Procedure: Endoscopic mucosal resection
Endoscopic resection is carried out using a double-channel scope. The lesion borders are marked with a coagulator. Saline liquid and sometimes epinephrine are injected into the submucosal layer to swell the area containing the lesion and elucidate the markings. The resected mucosa is lifted, then trapped and strangulated with a snare, and subsequently resected by electrocautery. Another method of EMR employs the use of a clear cap and prelooped snare inside the cap. After insertion, the cap is placed on the lesion and the mucosa containing the lesion is drawn up inside the cap by aspiration. The mucosa is caught by the snare and strangulated, and finally resected by electrocautery.
Other Names:
  • EMR
  • Piecemeal EMR
Active Comparator: ESD
Endoscopic submucosal dissection
Procedure: Endoscopic submucosal dissection
After circumferential cutting of the surrounding mucosa of the lesion, fluid is injected into the submucosa to elevate the lesion from the muscle layer, and the connective tissue of the submucosa beneath the lesion is dissected subsequently.
Other Names:
  • ESD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eradication rate of neoplastic Barrett's Esophagus, initial therapy success
Time Frame: 3 months after end of therapy (resection and ablation)
Rate of complete and curative eradication, free of recurrence of neoplastic Barrett's Esophagus. Endoscopical diagnostic and negative histologies for any kind of neoplasia, measured in follow up control EGD 3 months after end of treatment
3 months after end of therapy (resection and ablation)
Eradication rate of neoplastic Barrett's Esophagus, initial therapy success
Time Frame: 9 months after end of therapy (resection and ablation)
Rate of complete and curative eradication, free of recurrence of neoplastic Barrett's Esophagus. Endoscopical diagnostic and negative histologies for any kind of neoplasia, measured in follow up control EGD 9 months after end of treatment
9 months after end of therapy (resection and ablation)
Eradication rate of neoplastic Barrett's Esophagus
Time Frame: 24 months after end of therapy (resection and ablation)
Rate of complete and curative eradication, free of recurrence of neoplastic Barrett's Esophagus. Endoscopical diagnostic and negative histologies for any kind of neoplasia, measured in follow up control 24 months after end of treatment
24 months after end of therapy (resection and ablation)
Eradication rate of neoplastic Barrett's Esophagus
Time Frame: 33 months after end of therapy (resection and ablation)
Rate of complete and curative eradication, free of recurrence of neoplastic Barrett's Esophagus. Endoscopical diagnostic and negative histologies for any kind of neoplasia, measured in follow up control EGD 33 months after end of treatment
33 months after end of therapy (resection and ablation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eradication rate of complete Barrett's Esophagus, initial therapy success
Time Frame: 3 months after end of treatment (resection and ablation)
Rate of complete and curative eradication, free of recurrence of neoplastic and non-neoplastic Barrett's Esophagus. Endoscopical diagnostics and negative histologies for any kind of neoplasia and Barrett's metaplasia measured in follow up control EGD 3 months after end of treatment
3 months after end of treatment (resection and ablation)
Eradication rate of complete Barrett's Esophagus, initial therapy success
Time Frame: 9 months after end of treatment (resection and ablation)
Rate of complete and curative eradication, free of recurrence of neoplastic and non-neoplastic Barrett's Esophagus. Endoscopical diagnostics and negative histologies for any kind of neoplasia and Barrett's metaplasia measured in follow up control EGD 9 months after end of treatment
9 months after end of treatment (resection and ablation)
Eradication rate of complete Barrett's Esophagus, freedom of recurrence
Time Frame: 24 months after end of treatment (resection and ablation)
Rate of complete and curative eradication, free of recurrence of neoplastic and non-neoplastic Barrett's Esophagus. Endoscopical diagnostics and negative histologies for any kind of neoplasia and Barrett's metaplasia measured in follow up control EGD 24 months after end of treatment
24 months after end of treatment (resection and ablation)
Eradication rate of complete Barrett's Esophagus, freedom of recurrence
Time Frame: 33 months after end of treatment (resection and ablation)
Rate of complete and curative eradication, free of recurrence of neoplastic and non-neoplastic Barrett's Esophagus. Endoscopical diagnostics and negative histologies for any kind of neoplasia and Barrett's metaplasia measured in follow up control EGD 33 months after end of treatment
33 months after end of treatment (resection and ablation)
Recurrence rate of neoplastic Barrett's Esophagus, initial therapy success
Time Frame: 3 months after end of therapy (resection and ablation)
rate of complete and curative eradication of neoplastic Barrett's Esophagus measured in follow up control EGD 3 months, Endoscopical diagnostic and negative histologies for any kind of neoplasia.
3 months after end of therapy (resection and ablation)
Recurrence rate of neoplastic Barrett's Esophagus, initial therapy success
Time Frame: 9 months after end of therapy (resection and ablation)
rate of complete and curative eradication of neoplastic Barrett's Esophagus measured in follow up control EGD 9 months , Endoscopical diagnostic and negative histologies for any kind of neoplasia.
9 months after end of therapy (resection and ablation)
freedom of recurrence rate of complete Barrett's Esophagus, initial therapy success
Time Frame: 9 months after end of treatment (resection and ablation)
Freedom of recurrence rate of neoplastic and non-neoplastic Barrett's Esophagus. Endoscopical diagnostics and negative histologies for any kind of neoplasia and Barrett's metaplasia measured in follow up control EGD 9 months (initial therapy success) after end of treatment
9 months after end of treatment (resection and ablation)
ESD success of resection
Time Frame: 2 days
rate of en bloc and R0 resections among the initially by ESD resected tissues
2 days
EMR success of resection
Time Frame: 9 months after end of treatment (resection and ablation)
Since with EMR resection success can only be measured for the depth of base initially, the second control EGD with negative histology has been chosen for Gold standard indication for resection success. After 2 negative bioptic controls a piecemeal resection of early carcinoma is classified as complete.
9 months after end of treatment (resection and ablation)
Surveillance of Barrett's mucosa after incomplete resections and recurrences
Time Frame: 51 months
follow up of all cases with initially incomplete EMR or ESD resections as well as recurrences after resection and ablation
51 months
conclusions of Tumor Board in case of re resection and outcome if postitive cancer histology
Time Frame: 51 months
any Treatment and follow up in case of positive cancer histology
51 months
Determination of differences in Barrett's esophagus subtypes: size
Time Frame: 3 months
size of Barrett's mucosa, e.g. Prague Classification
3 months
Determination of differences in Barrett's esophagus subtypes: form
Time Frame: 3 months
form of Barrett's mucosa
3 months
Determination of differences in Barrett's esophagus subtypes: patterns
Time Frame: 3 months
patterns of Barrett's mucosa, e,g, Kudo Classification
3 months
Determination of differences in Barrett's esophagus subtypes: histologies
Time Frame: 3 months
histological assessment of Barrett's mucosa
3 months
Intervention time
Time Frame: 18 months
time requested for each resection and ablative sessions
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Rösch, Prof. Dr., Ph D, Director, Head of department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PV5387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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