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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.GE

Abstract

BACKGROUND

Endoscopic ablation is an accepted standard for neoplasia in Barrett's esophagus (BE). Eradication of all glandular mucosa in the distal esophagus cannot be reliably determined at endoscopy.

OBJECTIVE

To assess if use of probe-based confocal laser endomicroscopy (pCLE) in addition to high-definition white light (HDWL) could aid in determination of residual BE.

DESIGN

Prospective, multicenter, randomized, clinical trial.

SETTING

Academic medical centers.

PATIENTS

Patients with Barrett's esophagus undergoing ablation.

INTERVENTION

After an initial attempt at ablation, patients were followed-up either with HDWL endoscopy or HDWL plus pCLE, with treatment of residual metaplasia or neoplasia based on endoscopic findings and pCLE used to avoid overtreatment.

MAIN OUTCOME MEASUREMENTS

The proportion of optimally treated patients, defined as those with residual BE who were treated and had complete ablation plus those without BE who were not treated and had no evidence of disease at follow-up.

RESULTS

The study was halted at the planned interim analysis based on a priori criteria. After enrollment was halted, all patients who had been randomized were followed to study completion. Among the 119 patients with follow-up, there was no difference in the proportion of patients achieving optimal outcomes in the two groups (15/57, 26% for HDWL; 17/62, 27% with HDWL + pCLE). Other outcomes were similar in the two groups.

LIMITATIONS

The study was closed after the interim analysis due to low conditional power resulting from lack of difference between groups as well as higher-than-expected residual Barrett's esophagus in both arms.

CONCLUSION

This study yields no evidence that the addition of pCLE to HDWL imaging for detection of residual Barrett's esophagus or neoplasia can provide improved treatment.

Authors+Show Affiliations

Mayo Clinic, Jacksonville, Florida, USA. Wallace.michael@mayo.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

22749368

Citation

Wallace, Michael B., et al. "Multicenter, Randomized, Controlled Trial of Confocal Laser Endomicroscopy Assessment of Residual Metaplasia After Mucosal Ablation or Resection of GI Neoplasia in Barrett's Esophagus." Gastrointestinal Endoscopy, vol. 76, no. 3, 2012, pp. 539-47.e1.
Wallace MB, Crook JE, Saunders M, et al. 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;76(3):539-47.e1.
Wallace, M. B., Crook, J. E., Saunders, M., Lovat, L., Coron, E., Waxman, I., Sharma, P., Hwang, J. H., Banks, M., DePreville, M., Galmiche, J. P., Konda, V., Diehl, N. N., & Wolfsen, H. C. (2012). Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointestinal Endoscopy, 76(3), 539-e1. https://doi.org/10.1016/j.gie.2012.05.004
Wallace MB, et al. 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;76(3):539-47.e1. PubMed PMID: 22749368.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. AU - Wallace,Michael B, AU - Crook,Julia E, AU - Saunders,Michael, AU - Lovat,Laurence, AU - Coron,Emmanuel, AU - Waxman,Irving, AU - Sharma,Prateek, AU - Hwang,Joo H, AU - Banks,Matthew, AU - DePreville,Mathieu, AU - Galmiche,Jean P, AU - Konda,Vani, AU - Diehl,Nancy N, AU - Wolfsen,Herbert C, Y1 - 2012/06/28/ PY - 2012/01/09/received PY - 2012/05/02/accepted PY - 2012/7/4/entrez PY - 2012/7/4/pubmed PY - 2013/1/24/medline SP - 539 EP - 47.e1 JF - Gastrointestinal endoscopy JO - Gastrointest. Endosc. VL - 76 IS - 3 N2 - BACKGROUND: Endoscopic ablation is an accepted standard for neoplasia in Barrett's esophagus (BE). Eradication of all glandular mucosa in the distal esophagus cannot be reliably determined at endoscopy. OBJECTIVE: To assess if use of probe-based confocal laser endomicroscopy (pCLE) in addition to high-definition white light (HDWL) could aid in determination of residual BE. DESIGN: Prospective, multicenter, randomized, clinical trial. SETTING: Academic medical centers. PATIENTS: Patients with Barrett's esophagus undergoing ablation. INTERVENTION: After an initial attempt at ablation, patients were followed-up either with HDWL endoscopy or HDWL plus pCLE, with treatment of residual metaplasia or neoplasia based on endoscopic findings and pCLE used to avoid overtreatment. MAIN OUTCOME MEASUREMENTS: The proportion of optimally treated patients, defined as those with residual BE who were treated and had complete ablation plus those without BE who were not treated and had no evidence of disease at follow-up. RESULTS: The study was halted at the planned interim analysis based on a priori criteria. After enrollment was halted, all patients who had been randomized were followed to study completion. Among the 119 patients with follow-up, there was no difference in the proportion of patients achieving optimal outcomes in the two groups (15/57, 26% for HDWL; 17/62, 27% with HDWL + pCLE). Other outcomes were similar in the two groups. LIMITATIONS: The study was closed after the interim analysis due to low conditional power resulting from lack of difference between groups as well as higher-than-expected residual Barrett's esophagus in both arms. CONCLUSION: This study yields no evidence that the addition of pCLE to HDWL imaging for detection of residual Barrett's esophagus or neoplasia can provide improved treatment. SN - 1097-6779 UR - https://www.unboundmedicine.com/medline/citation/22749368/Multicenter_randomized_controlled_trial_of_confocal_laser_endomicroscopy_assessment_of_residual_metaplasia_after_mucosal_ablation_or_resection_of_GI_neoplasia_in_Barrett's_esophagus_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5107(12)02244-4 DB - PRIME DP - Unbound Medicine ER -