Esophageal Cancer Clinical Trial

Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection

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.

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Full 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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Eligibility 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

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

407

Study ID:

NCT03427346

Recruitment Status:

Recruiting

Sponsor:

Universitätsklinikum Hamburg-Eppendorf

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There are 2 Locations for this study

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Orlando Health
Orlando Florida, 32806, United States More Info
Pamela Beck
Contact
321-841-6696
[email protected]
Ginette Garcia De Djuro, CCMA
Contact
321- 841-6649
[email protected]
Ji Young Bang, MD MPH
Principal Investigator
Shyam Varadarajulu, MD
Sub-Investigator
Robert Hawes, MD
Sub-Investigator
Udayakumar Navaneethan, MD
Sub-Investigator
University Medical Center Hamburg-Eppendorf
Hamburg , 20246, Germany More Info
Thomas Rösch, Prof. Dr.
Contact
+ 49 40 7410
[email protected]
Tania Ruppenthal
Contact
+ 49 40 7410
[email protected]
Thomas Rösch, Prof. Dr.
Principal 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.
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

407

Study ID:

NCT03427346

Recruitment Status:

Recruiting

Sponsor:


Universitätsklinikum Hamburg-Eppendorf

How clear is this clinincal trial information?

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