Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer

April 10, 2026 updated by: Hunter Holmes Mcguire Veteran Affairs Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • 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

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Center for Advanced Medicine

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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in dysphagia severity according to validated symptom score
Time Frame: 2 weeks after cryoablation session
2 weeks after cryoablation session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 12 weeks
Assessment of pathologic complete response and clinical complete response at the completion of neo-adjuvant chemoradiation number one.
Time Frame: Up to 24 weeks
Results of the re-staging PET-CT will be abstracted from the medical record to document presence or absence of a pathologic complete response
Up to 24 weeks
Assessment of pathologic complete response and clinical complete response at the completion of neo-adjuvant chemoradiation number two.
Time Frame: Up to 24 weeks
Results of the surgical explant will be abstracted from the medical record to document presence or absence of a pathologic complete response.
Up to 24 weeks
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 last cryoablation session
1 week after each procedure; 2 to 3 weeks after each procedure and 8 weeks after completion of the last cryoablation session

Collaborators and Investigators

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

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Investigators

  • Principal Investigator: Vladimir M Kushnir, MD, Washington University School of Medicine

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 (Actual)

April 19, 2016

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimated)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201510035

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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