Balloon Dilation to Permit Complete Endoscopic Ultrasound Staging in Esophageal Cancer (CT0046)

August 31, 2017 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Balloon Dilation of Malignant Strictures to Permit Complete Endoscopic Ultrasound Staging in Esophageal Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The gold standard for evaluating the local extension of esophageal cancer is endoscopic ultrasound (EUS). The tumor extension into the esophageal wall (T stage) is best assessed using EUS. Suspicious lymph nodes in the mediastinum and in lymph node basins drained by the tumor (N stage) can be biopsied through the esophagus with fine needle aspiration (FNA) to obtain pathologic confirmation. Computed tomography (CT) and positron-emission tomography (PET) are used for the assessment of metastatic disease(M stage). In selected patients with liver lesions, EUS can be utilized to biopsy these and confirm metastatic disease. In the absence of metastatic disease, the local extent of the disease is an important factor in making the decision between surgery alone, neoadjuvant chemo-radiotherapy followed by surgery, surgery followed by chemoradiation or inoperability.

A difficult situation is encountered in patients with malignant strictures, where the EUS scope cannot be passed across the tumor and into the distal esophagus and stomach. There are several problems with this situation. The first is the inability to assess the complete T stage of the tumor. This can be associated with under T-staging. Also, the mediastinal and intra-abdominal lymph nodes distal to the tumor are not assessed, and this can also lead to inaccurate staging (N and M understaging). Patients with high grade malignant strictures have a worse prognosis, and therefore accurate staging and appropriate application of therapeutic options becomes paramount in providing the optimal treatment plan for this population.

To circumvent the problem of incomplete staging due to tight malignant strictures, one option that has been recently employed is gentle dilation of the malignant stricture, enough to allow passage of the scope. It is important to stress that the purpose is not to relieve any symptoms of dysphagia, but rather to allow passage of the scope to evaluate the TNM stage. There has been mixed results with regards to the safety of this technique. The following table summarizes the results of the studies evaluating dilation during endoscopic staging of esophageal cancer. The earliest reports quote a high complication rate of 24%, specifically related to perforation10. In the current era and with more experience gained in endoscopic diagnostic and therapeutic applications, there have been more reports of patients safely undergoing dilatation to permit complete endosonographic evaluation. The most recent studies report no perforations in their series. Except for the study performed by Pfau et al., the numbers are quite small with less than 40 patients in 3 of the studies. Furthermore, only one study by Wallace et al. reports any change in the staging offered by completing the EUS examination.

The study consists of a phase I clinical trial. All patients currently undergoing esophageal cancer staging in the Division of Thoracic Surgery at the CHUM will be approached for potential enrolment into the study. This staging is currently going on within the staging protocol for esophageal cancer and therefore is not a change in practise, however, patients refusing enrolment will not have there data included in the study database and their outcomes will not be used in any way for research protocols.

Patients with a malignant stricture that precludes passage of the dedicated endosonographic scope will comprise the study group. In this situation, an over-the-wire balloon dilation will be performed up to 14 mm. Patients in whom a standard adult gastroscope does not traverse the stricture, a pediatric gastrosocpe will be utilized in order to allow tumor traversal and guidewire placement into the stomach under endoscopic visualization. This will be performed in order to avoid dilating through the tumor and inadvertently causing a perforation. Once the dilation is complete, a complete EUS examination will be undertaken. EUS, followed by EBUS in selected patients with lymphadenopathy in the high mediastinal lymph nodes will be performed for staging.

All patients will undergo upright chest x-rays following their procedure in order to assess for pneumoperitoneum and pneumomediastinum. Patients will be discharged, as usual, following their procedure. Results will be discussed with them in a follow-up clinic appointment with their thoracic surgeon within 3 to 4 weeks of the procedure. Any procedure-related morbidity will be documented in the post-procedural period as well as at follow-up in the clinic. In patients sent from another hospital for EUS staging of esophageal cancer, which are not treated and followed at the CHUM, a 30 day telephone interview will be performed to assess for complications in the 30-day post-procedure period.

F. Data Points to be Collected

  • Age
  • Sex
  • Comorbidties
  • BMI
  • Tumor location
  • Tumor histology
  • CT stage
  • PET stage
  • EUS T stage
  • EUS N stage
  • EUS M stage
  • EUS lymph node FNA results
  • EBUS lymph node FNA results
  • Change in treatment plan based on completed EUS
  • Procedural morbidity related to staging procedure
  • 30-day morbidity related to staging procedure
  • Pathologic staging, if available after undergoing surgical resection

Analysis will focus on:

  1. Ability to complete an endosonographic examination after dilation
  2. Safety profile of minimal dilation to allow passage of the EUS scopes
  3. Change in treatment plan based on the completed endosonographic examination of esophageal cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de L'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of gentle dilation
Time Frame: 10 months

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
impact on staging
Time Frame: 10 months
Examine the impact on staging gained by completing the EUS examination after dilation compared to the situation of non-dilation (incomplete staging due to non-passage of tumor).
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Moishe Liberman, MD, PhD, CHUM-Centre Universitaire de Montreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CE13.118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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