CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

NCT01032044 | Completed Results

• 1 other identifier: MKT-2009-BE-01
• Study Type: interventional
• Target: 164
• Locations: 3 countries
• Sites: 6

Brief Summary

This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE). It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

Conditions

Barrett Syndrome; Barrett's Syndrome; Barrett's Esophagus; Barrett Esophagus; Adenocarcinoma

Keywords

Barrett's esophagus; EsoGastroDuodenoscopy; Barrett's carcinoma; adenocarcinoma; Cellvizio; endomicroscopy; probe-based Confocal Laser Endomicroscopy; pCLE; Radio-frequency ablation; Endoscopic mucosal resection; Photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"

  Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of "Optimally Treated", in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.

  3 month follow-up endoscopic procedure

Study Arms (2)

Standard endoscopic evaluation

ACTIVE COMPARATOR

Standard high-definition white light endoscopy guided evaluation

Device: Standard endoscopic evaluation

pCLE-guided evaluation

EXPERIMENTAL

Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)

Device: pCLE guided evaluation

Interventions

Standard endoscopic evaluation DEVICE

Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy

Standard endoscopic evaluation

pCLE guided evaluation DEVICE

Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure.

pCLE-guided evaluation

Eligibility Criteria

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

You may qualify if:

• Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.
• Undergoing any type of endoscopic BE ablation treatment
• \<2cm of circumferential BE and \<5 total islands of BE on prior to last ablation.
• Age \> 18 years
• Ability to provide written, informed consent

You may not qualify if:

• Participation in another clinical study
• Circumferential BE
• Complete eradication of BE documented by biopsies
• Inability to obtain biopsies due to anticoagulation, varices, etc.
• Allergy to fluorescein
• Pregnancy
• Renal insufficiency

Sponsors & Collaborators

• Mauna Kea Technologies: lead
• Cellvizio Inc.: collaborator

Study Sites (6)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

Veterans Affairs Hospital

Kansas City, Missouri, 64128, United States

Location

University of Washington Medical Center

Seattle, Washington, 98115, United States

Location

Centre Hospitalier Universitaire

Nantes, France

Location

University College London Hospital

London, United Kingdom

Location

Related Publications (1)

• Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.

  PMID: 22749368 DERIVED

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Dr Michael B. Wallace
• Organization: Mayo Clinic, Jacksonville, Florida, USA

wallace.michael@mayo.edu

904 953-7630

Study Officials

• Michael Wallace, MD

  Mayo Clinic Jacksonville, Florida, United States

  PRINCIPAL INVESTIGATOR

• Anne Osdoit

  Mauna Kea Technologies, Paris, France

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 15, 2009
• Study Start: February 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 22, 2016
• Results First Posted: April 22, 2016

Record last verified: 2016-03

Locations

GB (1); FR (1); US (4)