Saint Louis, Missouri 63110


Purpose:

Esophageal adenocarcinoma (EAC) is one of the few cancers with a rising incidence in the United States, with an estimated 17,000 new cases diagnosed in 2012. Most patients with esophageal cancer present with tumors which are not amenable to surgery and are treated with chemotherapy and radiation. The most common and bothersome symptoms from esophageal cancer is dysphagia (difficulty swallowing). Chemotherapy and radiation are effective in shrinking tumors and allowing patients with EAC to swallow more easily; however it usually takes 1-2 months for swallowing to improve with this treatment. Another method of shrinking esophageal tumors and allowing for better swallowing is endoscopic spray cryotherapy (freezing the tumor from inside the esophagus with the aid of an endoscope); cryotherapy is a well established method for treating cancerous and pre-cancerous esophageal disease. This is a particularly attractive treatment option, as patients with esophageal cancer usually undergo endoscopy on several occasions before starting treatment in order to biopsy and evaluate the tumor. The goal of this study is to evaluate the effectiveness of cryotherapy in treating EAC related dysphagia in patients who are getting ready to start chemotherapy and radiation. In order to do this the investigators are planning to invite patients who are already undergoing endoscopy for pre-chemotherapy evaluation of known EAC. Patients would undergo cryotherapy after the diagnostic portion of the endoscopy has been completed. After the cryotherapy patients will be contacted by phone in order to evaluate change in symptoms, 2 and 4 weeks after cryotherapy.


Study summary:

Endoscopic spray cryotherapy (EC) is a novel modality for destruction of tissue in the gastrointestinal tract. EC involves the endoscopic application of cryogen [liquid nitrogen (LN)], which destroys tissue by rapid freezing and slow thawing. Immediate effects from tissue freezing include failure of cellular metabolism, membrane damage and local ischemia. Delayed effects may include apoptosis of cancer cells and immune mediated tumor destruction. EC has been used for the treatment of mucosal EAC and palliation of malignant dysphagia since 2007 in multiple tertiary centers, including Washington University in St Louis, with positive results. EC is an attractive modality for the palliation of malignant dysphagia in EAC due to the fact that newly diagnosed patients undergo upper endoscopy (EGD) and endoscopic ultrasound (EUS) as part of initial staging; thus EC could be delivered at the time of the staging endoscopy, without burdening the patient with an additional procedure. However, prospective studies on the efficacy of EC in the short term palliation of malignant dysphagia in EAC have not been performed. Thus, the goal of this pilot study is to evaluate the effectiveness of EC in the short term palliation of malignant dysphagia in patients with unresectable EAC.


Criteria:

Inclusion Criteria: - Patients >18 years of age with malignant dysphagia due to locally advanced EAC (≥T3 and/or N1) who are undergoing upper endoscopic ultrasound or upper endoscopy for pre-treatment staging or symptom evaluation Exclusion Criteria: - Prior esophageal or gastro-esophageal junction surgery. - Prior diagnosis of oropharyngeal dysphagia. - Prior diagnosis of esophageal achalasia. - Esophageal strictures unrelated to EAC - Distant metastasis - Dysphagia only to solid or semi-solid foods - Need for esophageal dilation in order to pass the diagnostic upper endoscope distal to the tumor. - Coagulopathy (INR>2, platelets < 50,000) - Inability to provide informed consent. - Marfan's syndrome


Study is Available At:


Original ID:

201510035


NCT ID:

NCT02606396


Secondary ID:


Study Acronym:


Brief Title:

Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer


Official Title:

Palliation of Malignant Dysphagia With Spray Cryotherapy in Patients With Advanced Esophageal Cancer: A Pilot Study


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hunter Holmes Mcguire Veteran Affairs Medical Center


Oversight Authority:

United States: Data and Safety Monitoring Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Vladimir M Kushnir, MD
Principal Investigator
Washington University School of Medicine
Primary Contact:Vladimir M Kushnir, MD
314-362-3685
vkushnir@dom.wustl.edu

Study Dates

Start Date:November 2015
Completion Date:June 2018
Completion Type:Anticipated
Primary Completion Date:June 2018
Primary Completion Type:Anticipated
Verification Date:July 2017
Last Changed Date:July 17, 2017
First Received Date:November 9, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Incidence of procedure related adverse events, classified according to the American Society of Gastrointestinal Endoscopy lexicon
Time Frame:1 week after each procedure; 2 to 3 weeks after each procedure and 8 weeks after completion of the l
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Assessment of pathologic complete response and clinical complete response at the completion of neo-adjuvant chemoradiation number two.
Time Frame:Up to 24 weeks
Safety Issues:False
Description:Results of the surgical explant will be abstracted from the medical record to document presence or absence of a pathologic complete response.
Outcome Type:Secondary Outcome
Measure:Assessment of pathologic complete response and clinical complete response at the completion of neo-adjuvant chemoradiation number one.
Time Frame:Up to 24 weeks
Safety Issues:False
Description:Results of the re-staging PET-CT will be abstracted from the medical record to document presence or absence of a pathologic complete response
Outcome Type:Secondary Outcome
Measure:Ability to maintain oral intake evaluated by a member of the study team utilizing dysphagia assessment and oral intake assessment instruments who will contact each patient at 1-month intervals while the patient receives chemoradiation
Time Frame:Up to 12 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in dysphagia severity according to validated symptom score
Time Frame:2 weeks after cryoablation session
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Cryotherapy
Description:Cryotherapy employs thermal ablation to treat esophageal cancer and BE. Ablation is achieved by intracellular disruption and ischemia that is produced by freeze-thaw cycles using liquid nitrogen or carbon dioxide
Intervention Type:Procedure
Name:Esophagogastroduodenoscopy (EGD)
Description:EGD is a diagnostic procedure that allows the physician to diagnose and treat problems in the upper gastrointestinal (UGI) tract. The doctor uses a long, flexible, lighted tube called an endoscope.
Intervention Type:Procedure
Name:Endoscopic ultrasound (EUS)
Description:EUS is a procedure that allows a doctor to obtain images and information about the digestive tract and the surrounding tissue and organs, including the lungs. Ultrasound testing uses sound waves to make a picture of internal organs.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Hunter Holmes Mcguire Veteran Affairs Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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