Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer

NCT02606396 | Completed DMC

• 1 other identifier: 201510035
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Esophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Change in dysphagia severity according to validated symptom score

  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

  Up to 12 weeks

• Assessment of pathologic complete response and clinical complete response at the completion of neo-adjuvant chemoradiation number one.

  Up to 24 weeks

• Assessment of pathologic complete response and clinical complete response at the completion of neo-adjuvant chemoradiation number two.

  Up to 24 weeks

• Incidence of procedure related adverse events, classified according to the American Society of Gastrointestinal Endoscopy lexicon

  1 week after each procedure; 2 to 3 weeks after each procedure and 8 weeks after completion of the last cryoablation session

Interventions

Cryotherapy PROCEDURE

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

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead

Study Sites (1)

Center for Advanced Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

Cryotherapy; Endoscopy, Digestive System; Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Therapeutics; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Investigative Techniques

Study Officials

• Vladimir M Kushnir, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 17, 2015
• Study Start: April 19, 2016
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)