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NCT Number: NCT01032044

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

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.

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Key information

Conditions

Barrett Syndrome Adenocarcinoma Barrett Esophagus Barrett's Esophagus Barrett's Syndrome Carcinoma Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire, Nantes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard endoscopic evaluation

Device

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

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.

Primary outcomes

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

    Time frame: 3 month follow-up endoscopic procedure

    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.

Sponsors and collaborators

Lead sponsor

Mauna Kea Technologies

Industry

Collaborators

  • Cellvizio Inc.

Registry information

Official study title

Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

Acronym: CLEAN-MARGIN

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2009
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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