Balloon Dilation to Permit Complete Endoscopic Ultrasound Staging in Esophageal Cancer

NCT01950442 | Completed

• 1 other identifier: CE13.118
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Despite improvement in treatment-related morbidity and mortality, esophageal cancer is still one of the most lethal malignancies. Accurate staging is essential to establish prognosis and for patient management. Staging helps to determine if surgery, chemotherapy, radiation therapy, a combination of these, or a palliative approach is the most appropriate. Endoscopic ultrasound techniques are becoming more and more popular. At Notre Dame Hospital, Centre Hospitalier de L'Universite de Montreal, all patients diagnosed with esophageal cancer undergo complete EUS staging. In selected patients, EUS is followed by EBUS during the same procedure, in order to examine all the lymph nodes near or far from the primary tumor amenable to EBUS guided trans-bronchial biopsy. In patients with a malignant esophageal stricture, we have preformed very gentle balloon dilation up to 14 mm. It is important to realize that this is not to achieve symptom resolution, but rather to allow the passage of the scope. We hypothesize that earlier reports of higher perforation rates were related to unnecessary aggressive dilation. Thus far, we have successfully dilated over 60 patients during the last four years (2009-2013) and were able to pass the scope and complete the examination in the vast majority of patients with no morbidity.

Conditions

Esophageal Cancer

Keywords

malignant strictures; esophageal staging

Outcome Measures

Primary Outcomes (1)

• Safety of gentle dilation

  Examine the safety of gentle dilation of a malignant stricture to permit a complete endosonographic examination in patients with strictures not allowing passage of the EUS scope. Determine the proportion of patients that could undergo a complete EUS examination after dilation up to a maximum 14 mm.

  10 months

Secondary Outcomes (1)

• impact on staging

  10 months

Interventions

Balloon dilation DEVICE

Eligibility Criteria

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

You may qualify if:

• Biopsy proven esophageal cancer
• Endoluminal esophageal mass without previous biopsy
• Medical suitability for endoscopic procedure
• Ability to consent

You may not qualify if:

• Patient on Coumadin (Warfarin), Plavix (Clopidogrel) or other anticoagulants with inability to stop medication for 5 days prior to procedure
• Tumors so tight that even a pediatric endoscope cannot traverse the stricture

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

• Molina JC, Goudie E, Pollock C, Menezes V, Ferraro P, Lafontaine E, Martin J, Nasir B, Liberman M. Balloon Dilation for Endosonographic Staging in Esophageal Cancer: A Phase 1 Clinical Trial. Ann Thorac Surg. 2021 Apr;111(4):1150-1155. doi: 10.1016/j.athoracsur.2020.06.063. Epub 2020 Aug 29.

  PMID: 32866480 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Moishe Liberman, MD, PhD

  CHUM-Centre Universitaire de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 25, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-08

Locations

CA (1)