- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01950442
Balloon Dilation to Permit Complete Endoscopic Ultrasound Staging in Esophageal Cancer (CT0046)
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
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:
- Ability to complete an endosonographic examination after dilation
- Safety profile of minimal dilation to allow passage of the EUS scopes
- Change in treatment plan based on the completed endosonographic examination of esophageal cancer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H2L 4M1
- Centre Hospitalier de l'Université de Montréal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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
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
Investigators
- Principal Investigator: Moishe Liberman, MD, PhD, CHUM-Centre Universitaire de Montreal
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Esophageal Cancer
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OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
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National Cancer Institute (NCI)NRG OncologyCompletedEsophageal Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IB Esophageal Cancer AJCC v7United States
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AIO-Studien-gGmbHBristol-Myers SquibbCompletedEsophageal Cancer | Gastrooesophageal Cancer | Oesophageal Cancer | GastroEsophageal Cancer | Esophageal Cancers NOS | Oesophageal Cancer Metastatic | Esophageal Cancer Metastatic | Oesophageal Cancer NosGermany
-
Cancer Institute and Hospital, Chinese Academy...Tianjin Medical University Cancer Institute and Hospital; Sichuan Cancer Hospital...UnknownEsophageal Neoplasm | Esophageal Cancer TNM Staging Primary Tumor (T) T3 | Esophageal Cancer TNM Staging Primary Tumor (T) T2 | Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0 | Esophageal Cancer TNM Staging Distal Metastasis (M) M0China
-
Academisch Medisch Centrum - Universiteit van Amsterdam...UMC UtrechtCompletedEsophageal Cancer, Stage II | Esophageal Cancer Stage IIINetherlands
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Tianjin Medical University Cancer Institute and...The First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsUnknownEsophageal Cancer Stage III | Esophageal Cancer Stage IIBChina
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University of Wisconsin, MadisonActive, not recruitingResectable Esophageal Cancer | GastroEsophageal CancerUnited States
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Tianjin Medical University Cancer Institute and...Sun Yat-sen University; Cancer Institute and Hospital, Chinese Academy of Medical... and other collaboratorsNot yet recruitingStage III Esophageal Cancer | Stage II Esophageal Cancer
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Tianjin Medical University Cancer Institute and...UnknownStage III Esophageal Cancer | Stage II Esophageal CancerChina
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7 | Malignant Neoplasm of the Cervical Esophagus | Malignant Neoplasm...United States
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