Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03427346

Studienbeginn:
Dezember 2016

Letztes Update:
28.06.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Barrett Esophagus, Esophageal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Universitätsklinikum Hamburg-Eppendorf

Collaborator:
-

Studienleiter

Thomas Rösch, Prof. Dr.
Principal Investigator
Ph D, Director, Head of department

Kontakt

Thomas Rösch, Prof. Dr.
Kontakt:
Phone: + 49 40 7410
Phone (ext.): 50098
E-Mail: t.roesch@uke.de» Kontaktdaten anzeigen

Hanno Ehlken, Dr.
Kontakt:
Phone: + 49 40 7410
Phone (ext.): 18232
E-Mail: h.ehlken@uke.de» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

University Medical Center Hamburg-Eppendorf
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Thomas Rösch, Prof. Dr.
Phone: + 49 40 7410
Phone (ext.): 50098
E-Mail: t.roesch@uke.de

Tania Ruppenthal
Phone: + 49 40 7410
Phone (ext.): 50089
E-Mail: t.ruppenthal@uke.de» Ansprechpartner anzeigen

Orlando Health
32806 Orlando
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Pamela Beck
Phone: 321-841-6696
E-Mail: Pamela.Beck@orlandohealth.com

Ginette Garcia De Djuro, CCMA
Phone: 321- 841-6649
E-Mail: Ginette.GarciaDeDjuro@orlandohealth.com» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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

Studien-Arme

Active Comparator: EMR
Endoscopic mucosal resection
Active Comparator: ESD
Endoscopic submucosal dissection

Geprüfte Regime

Endoscopic mucosal resection (EMR / Piecemeal EMR / ):
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.
Endoscopic submucosal dissection (ESD):
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.

Quelle: ClinicalTrials.gov

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