Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer

Completed · Not applicable

Conditions studied: Esophageal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT02606396

Run by

Hunter Holmes Mcguire Veteran Affairs Medical Center

People needed

15

Starts

2016-04-19

Expected to finish

2022-03-15

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.