Clinical trial · Interventional
Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer
Palliation of Malignant Dysphagia With Spray Cryotherapy in Patients With Advanced Esophageal Cancer: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryotherapy | Procedure | — | UNRESOLVED |
| Endoscopic ultrasound (EUS) | Procedure | — | UNRESOLVED |
| Esophagogastroduodenoscopy (EGD) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in dysphagia severity according to validated symptom score
- timeFrame
- 2 weeks after cryoablation session
Secondary outcomes (4)
- 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
- timeFrame
- Up to 12 weeks
- measure
- Assessment of pathologic complete response and clinical complete response at the completion of neo-adjuvant chemoradiation number one.
- timeFrame
- Up to 24 weeks
- 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
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available