Clinical trial NCT01032044: CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Official title: Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
Collaborators: name: Cellvizio Inc.
First posted: 2009-12-15
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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 guided evaluation (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
timeFrame: 3 month follow-up endoscopic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Kansas City
country: United States
facility: Veterans Affairs Hospital
state: Missouri
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Nantes
country: France
facility: Centre Hospitalier Universitaire
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: Mayo Clinic Jacksonville, Florida, United States
name: Michael Wallace, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mauna Kea Technologies, Paris, France
name: Anne Osdoit
role: STUDY_DIRECTOR
References:
citation: 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.