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

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ClinicalTrials.gov Identifier: NCT03427346
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Barrett Adenocarcinoma Esophagus Neoplasm Procedure: Endoscopic mucosal resection Procedure: Endoscopic submucosal dissection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospektiv-randomisierter Vergleich Von En-bloc- Versus Piecemeal-Resektion Von Barrett Neoplasien Des Ösophagus Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection
Study Start Date : December 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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 Name: ESD




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. ESD success of resection [ Time Frame: 2 days ]
    rate of en bloc and R0 resections among the initially by ESD resected tissues

  9. 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.

  10. 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

  11. 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

  12. Determination of differences in Barrett's esophagus subtypes: size [ Time Frame: 3 months ]
    size of Barrett's mucosa, e.g. Prague Classification

  13. Determination of differences in Barrett's esophagus subtypes: form [ Time Frame: 3 months ]
    form of Barrett's mucosa

  14. Determination of differences in Barrett's esophagus subtypes: patterns [ Time Frame: 3 months ]
    patterns of Barrett's mucosa, e,g, Kudo Classification

  15. Determination of differences in Barrett's esophagus subtypes: histologies [ Time Frame: 3 months ]
    histological assessment of Barrett's mucosa

  16. Intervention time [ Time Frame: 18 months ]
    time requested for each resection and ablative sessions



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427346


Contacts
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Contact: Thomas Rösch, Prof. Dr. + 49 40 7410 ext 50098 t.roesch@uke.de
Contact: Hanno Ehlken, Dr. + 49 40 7410 ext 18232 h.ehlken@uke.de

Locations
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Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Thomas Rösch, Prof. Dr.    + 49 40 7410 ext 50098    t.roesch@uke.de   
Contact: Tania Noder    + 49 40 7410 ext 50089    t.noder@uke.de   
Principal Investigator: Thomas Rösch, Prof. Dr.         
Sub-Investigator: Hanno Ehlken, Dr.         
Sub-Investigator: Guido Schachschal, Dr.         
Sub-Investigator: Stefan Groth, Dr.         
Sub-Investigator: Yuki B. Werner, Dr.         
Sub-Investigator: Katharina Zimmermann-Fraedrich, Dr.         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Thomas Rösch, Prof. Dr. Ph D, Director, Head of department

Publications:

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Responsible Party: Prof. Dr. Thomas Rösch, Director of Department of Interdisciplinary Endoscopy, University Medical Center Hamburg-Eppendorf, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03427346     History of Changes
Other Study ID Numbers: PV5387
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf:
Barrett Esophagus
ESD
EMR
Esophagus Neoplasm
endoscopic resection technique
ablation of esophageal mucosa
Additional relevant MeSH terms:
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Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms