Recruiting

Endoscopic ResectionNeoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection

Sponsor:

Universitätsklinikum Hamburg-Eppendorf

Code:

NCT03427346

Conditions

Barrett Esophagus

Barrett Adenocarcinoma

Esophagus Neoplasm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Endoscopic mucosal resection

Endoscopic submucosal dissection

Study Details

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.

Conditions

Barrett Esophagus

Barrett Adenocarcinoma

Esophagus Neoplasm

Study ID

NCT03427346

Start date

Dec, 2016

Status verified date

Jun, 2023

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

407 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: EMR

Endoscopic mucosal resection

active comparator: ESD

Endoscopic submucosal dissection

Interventions

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.

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.

Primary outcome measure

Eradication rate of neoplastic Barrett's Esophagus, initial therapy success [ Time Frame: 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) ]
Eradication rate of neoplastic Barrett's Esophagus [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Thomas Rösch, Prof. Dr.

+ 49 40 7410 t.roesch@uke.de

Hanno Ehlken, Dr.

+ 49 40 7410 h.ehlken@uke.de

Locations

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Pamela Beck

321-841-6696 Pamela.Beck@orlandohealth.com

Ginette Garcia De Djuro, CCMA

321- 841-6649 Ginette.GarciaDeDjuro@orlandohealth.com

Principal Investigator:

Ji Young Bang, MD MPH

More Information

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Last update posted

Jun 28, 2023

Last verified

Jun, 2023

Keywords

Barrett Esophagus
ESD
EMR
Esophagus Neoplasm
endoscopic resection technique
ablation of esophageal mucosa

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf on 2023-06-28.