Esophageal AdenocarcinomaNCT02606396
Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer
A study testing Cryotherapy, Esophagogastroduodenoscopy (EGD) and Endoscopic ultrasound (EUS) in people with Esophageal Adenocarcinoma, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Adenocarcinoma
- What is being tested?
- Cryotherapy, Esophagogastroduodenoscopy (EGD) and Endoscopic ultrasound (EUS)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2016to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Advanced Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Esophageal Adenocarcinoma
- Being tested
- Cryotherapy, Esophagogastroduodenoscopy (EGD), Endoscopic ultrasound (EUS)
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
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
Esophagogastroduodenoscopy (EGD)Procedure or surgery
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.
Endoscopic ultrasound (EUS)Procedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dysphagia severity according to validated symptom score
Measured: 2 weeks after cryoablation session
Secondary outcomes (4)
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
Measured: Up to 12 weeks
Assessment of pathologic complete response and clinical complete response at the completion of neo-adjuvant chemoradiation number one.
Results of the re-staging PET-CT will be abstracted from the medical record to document presence or absence of a pathologic complete response
Measured: Up to 24 weeks
Assessment of pathologic complete response and clinical complete response at the completion of neo-adjuvant chemoradiation number two.
Results of the surgical explant will be abstracted from the medical record to document presence or absence of a pathologic complete response.
Measured: Up to 24 weeks
Incidence of procedure related adverse events, classified according to the American Society of Gastrointestinal Endoscopy lexicon
Measured: 1 week after each procedure; 2 to 3 weeks after each procedure and 8 weeks after completion of the last cryoablation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start19 Apr 2016
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Vladimir M Kushnir, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606396
- Sponsor's protocol ID
- 201510035
- Status last verified
- Apr 2026
- First submitted
- 9 Nov 2015
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliation of Malignant Dysphagia With Spray Cryotherapy in Patients With Advanced Esophageal Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT02606396
- Acronym / sponsor ID
- 201510035
- Conditions
- Esophageal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Study start
- 19 Apr 2016 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- Prior esophageal or gastro-esophageal junction surgery.
- Prior diagnosis of oropharyngeal dysphagia.
- Prior diagnosis of esophageal achalasia.
- Esophageal strictures unrelated to EAC
- Distant metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyCryotherapy 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 | Procedure or surgery | – |
| Esophagogastroduodenoscopy (EGD)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. | Procedure or surgery | – |
| Endoscopic ultrasound (EUS)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. | Procedure or surgery | – |
Primary outcome
Change in dysphagia severity according to validated symptom score
Time frame: 2 weeks after cryoablation session
4 secondary outcomes
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
Assessment of pathologic complete response and clinical complete response at the completion of neo-adjuvant chemoradiation number one.
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir M Kushnir, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy, Esophagogastroduodenoscopy (EGD) and Endoscopic ultrasound (EUS) in people with Esophageal Adenocarcinoma, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dysphagia severity according to validated symptom score (time frame: 2 weeks after cryoablation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.