Neoplastic Barrett Esophagus: Endoscopic Piecemeal vs. En Bloc Resection

NCT03427346 | Unknown

• 1 other identifier: PV5387
• Study Type: interventional
• Target: 407
• Locations: 2 countries
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Eradication rate of neoplastic Barrett's Esophagus, initial therapy success

  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

  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

  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

  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 Outcomes (16)

• Eradication rate of complete Barrett's Esophagus, initial therapy success

  3 months after end of treatment (resection and ablation)

• Eradication rate of complete Barrett's Esophagus, initial therapy success

  9 months after end of treatment (resection and ablation)

• Eradication rate of complete Barrett's Esophagus, freedom of recurrence

  24 months after end of treatment (resection and ablation)

• Eradication rate of complete Barrett's Esophagus, freedom of recurrence

  33 months after end of treatment (resection and ablation)

• Recurrence rate of neoplastic Barrett's Esophagus, initial therapy success

  3 months after end of therapy (resection and ablation)

Study Arms (2)

EMR

ACTIVE COMPARATOR

Endoscopic mucosal resection

Procedure: Endoscopic mucosal resection

ESD

ACTIVE COMPARATOR

Endoscopic submucosal dissection

Procedure: Endoscopic submucosal dissection

Interventions

Endoscopic mucosal resection PROCEDURE

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.

Also known as: EMR, Piecemeal EMR

EMR

Endoscopic submucosal dissection PROCEDURE

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.

Also known as: ESD

ESD

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (2)

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (11)

• Anders M, Bahr C, El-Masry MA, Marx AH, Koch M, Seewald S, Schachschal G, Adler A, Soehendra N, Izbicki J, Neuhaus P, Pohl H, Rosch T. Long-term recurrence of neoplasia and Barrett's epithelium after complete endoscopic resection. Gut. 2014 Oct;63(10):1535-43. doi: 10.1136/gutjnl-2013-305538. Epub 2014 Jan 3.

  PMID: 24389236 BACKGROUND

• BARRETT NR. The oesophagus lined by columnar epithelium. Gastroenterologia. 1956;86(3):183-6. doi: 10.1159/000200553. No abstract available.

  PMID: 13384591 BACKGROUND

• BARRETT NR. The lower esophagus lined by columnar epithelium. Surgery. 1957 Jun;41(6):881-94. No abstract available.

  PMID: 13442856 BACKGROUND

• Dunbar KB, Spechler SJ. Controversies in Barrett esophagus. Mayo Clin Proc. 2014 Jul;89(7):973-84. doi: 10.1016/j.mayocp.2014.01.022. Epub 2014 May 24.

  PMID: 24867396 BACKGROUND

• Edgren G, Adami HO, Weiderpass E, Nyren O. A global assessment of the oesophageal adenocarcinoma epidemic. Gut. 2013 Oct;62(10):1406-14. doi: 10.1136/gutjnl-2012-302412. Epub 2012 Aug 23.

  PMID: 22917659 BACKGROUND

• Hobel S, Dautel P, Baumbach R, Oldhafer KJ, Stang A, Feyerabend B, Yahagi N, Schrader C, Faiss S. Single center experience of endoscopic submucosal dissection (ESD) in early Barrett's adenocarcinoma. Surg Endosc. 2015 Jun;29(6):1591-7. doi: 10.1007/s00464-014-3847-5. Epub 2014 Oct 8.

  PMID: 25294533 BACKGROUND

• Labenz J, Koop H, Tannapfel A, Kiesslich R, Holscher AH. The epidemiology, diagnosis, and treatment of Barrett's carcinoma. Dtsch Arztebl Int. 2015 Mar 27;112(13):224-33; quiz 234. doi: 10.3238/arztebl.2015.0224.

  PMID: 25869347 BACKGROUND

• Neuhaus H. Endoscopic mucosal resection and endoscopic submucosal dissection in the West--too many concerns and caveats? Endoscopy. 2010 Oct;42(10):859-61. doi: 10.1055/s-0030-1255724. Epub 2010 Sep 30. No abstract available.

  PMID: 20886404 BACKGROUND

• Pech O, May A, Manner H, Behrens A, Pohl J, Weferling M, Hartmann U, Manner N, Huijsmans J, Gossner L, Rabenstein T, Vieth M, Stolte M, Ell C. Long-term efficacy and safety of endoscopic resection for patients with mucosal adenocarcinoma of the esophagus. Gastroenterology. 2014 Mar;146(3):652-660.e1. doi: 10.1053/j.gastro.2013.11.006. Epub 2013 Nov 20.

  PMID: 24269290 BACKGROUND

• Phoa KN, Pouw RE, Bisschops R, Pech O, Ragunath K, Weusten BL, Schumacher B, Rembacken B, Meining A, Messmann H, Schoon EJ, Gossner L, Mannath J, Seldenrijk CA, Visser M, Lerut T, Seewald S, ten Kate FJ, Ell C, Neuhaus H, Bergman JJ. Multimodality endoscopic eradication for neoplastic Barrett oesophagus: results of an European multicentre study (EURO-II). Gut. 2016 Apr;65(4):555-62. doi: 10.1136/gutjnl-2015-309298. Epub 2015 Mar 2.

  PMID: 25731874 BACKGROUND

• Spechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available.

  PMID: 25162890 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Thomas Rösch, Prof. Dr.

  Ph D, Director, Head of department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Rösch, Prof. Dr.

CONTACT

+ 49 40 7410; t.roesch@uke.de

Hanno Ehlken, Dr.

CONTACT

+ 49 40 7410; h.ehlken@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Interdisciplinary Endoscopy, University Medical Center Hamburg-Eppendorf

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: February 9, 2018
• Study Start: December 1, 2016
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); US (1)