Balloon Dilation for Endosonographic Staging in Esophageal Cancer: A Phase 1 Clinical Trial.
Journal
The Annals of thoracic surgery
ISSN: 1552-6259
Titre abrégé: Ann Thorac Surg
Pays: Netherlands
ID NLM: 15030100R
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
received:
23
01
2020
revised:
26
05
2020
accepted:
15
06
2020
pubmed:
1
9
2020
medline:
7
4
2021
entrez:
1
9
2020
Statut:
ppublish
Résumé
Dilation in patients with malignant esophageal strictures precluding the passage of the endoscopic ultrasonography (EUS) scope allows complete evaluation; however, it may be associated with complications. This study evaluates the safety and clinical value of balloon dilation to complete EUS in patients with stenotic esophageal cancers. This study consists of a phase I clinical trial. One-hundred-and fifty patients were recruited. Endoscopic balloon dilation was performed before EUS in patients with high-grade stenosis. The analysis was focused on the ability to complete an endosonographic examination after dilation, 30-day morbidity, and change in the final stage or definitive management based on the completed endosonographic examination. Dilation was required in 55 patients (36.7%), with a complication rate of 10.9% (n = 6). Dilation allowed completion of EUS in 53 patients (96.4%), leading to a modification of the clinical stage for 18 patients (34%) and a deviation in the treatment plan in 7 patients (13.2%). No differences were found in these variables when compared with the group that did not require dilation (26.3% and 14.7%, P = .33 and P = .79, respectively). Dilation was associated with more advanced disease on final pathology among patients who underwent surgical resection (P = .006). High-grade malignant esophageal strictures that preclude the passage of the ultrasound probe are associated with advanced stage disease. Owing to the high risk of perforation and the limited benefit in staging, balloon dilation to complete the EUS staging should be avoided. (Clinicaltrials.gov identifier: NCT01950442.).
Sections du résumé
BACKGROUND
Dilation in patients with malignant esophageal strictures precluding the passage of the endoscopic ultrasonography (EUS) scope allows complete evaluation; however, it may be associated with complications. This study evaluates the safety and clinical value of balloon dilation to complete EUS in patients with stenotic esophageal cancers.
METHODS
This study consists of a phase I clinical trial. One-hundred-and fifty patients were recruited. Endoscopic balloon dilation was performed before EUS in patients with high-grade stenosis. The analysis was focused on the ability to complete an endosonographic examination after dilation, 30-day morbidity, and change in the final stage or definitive management based on the completed endosonographic examination.
RESULTS
Dilation was required in 55 patients (36.7%), with a complication rate of 10.9% (n = 6). Dilation allowed completion of EUS in 53 patients (96.4%), leading to a modification of the clinical stage for 18 patients (34%) and a deviation in the treatment plan in 7 patients (13.2%). No differences were found in these variables when compared with the group that did not require dilation (26.3% and 14.7%, P = .33 and P = .79, respectively). Dilation was associated with more advanced disease on final pathology among patients who underwent surgical resection (P = .006).
CONCLUSIONS
High-grade malignant esophageal strictures that preclude the passage of the ultrasound probe are associated with advanced stage disease. Owing to the high risk of perforation and the limited benefit in staging, balloon dilation to complete the EUS staging should be avoided. (Clinicaltrials.gov identifier: NCT01950442.).
Identifiants
pubmed: 32866480
pii: S0003-4975(20)31359-X
doi: 10.1016/j.athoracsur.2020.06.063
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT01950442']
Types de publication
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1150-1155Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.