Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study

Study Overview
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Brief Summary
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Barrett's esophagus is a condition in which the normal lining of the lower esophagus is replaced with cells that predispose an individual to development of esophageal cancer. Treatment of Barrett's esophagus reduces the risk of progression to cancer. Treatment is provided endoscopically, via a variety of approved techniques including endoscopic mucosal resection, argon plasma coagulation, radiofrequency ablation (RFA), spray cryotherapy ablation and balloon cryotherapy ablation. A common side effect of ablation treatment is pain, thus making pain an important factor when discussing treatment options. It is speculated that balloon cryotherapy causes less pain than RFA but no head-to-head comparison trials exist to date. This multi-center, prospective cohort study aims to compare pre- and post-procedural pain for balloon cryotherapy versus RFA. Providing both patients and clinicians with data from a well-designed prospective study may help guide future physician/patient treatment discussions.

Official Title
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Post Procedural Pain Assessment in Patients Undergoing Balloon Cryotherapy Compared to Radiofrequency Ablation (RFA) for Dysplastic Barrett's: A Prospective Study

Conditions
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Barrett Esophagus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with dysplastic Barrett's esophagus (LGD and HGD) naïve to ablation therapy presenting for ablation Age ≥ 18 Ability to sign informed consent Exclusion Criteria: Prior ablation treatment for Barrett's esophagus Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Balloon Cryotherapy Treatment Group<br>Subjects will undergo endoscopic balloon cryotherapy for dysplastic Barrett's Esophagus as per standard of care. The treatment type (balloon cryotherapy vs RFA) is determined by the endoscopy physician at the time of the procedure and is based on several clinical factors including co-existing medical conditions, the anatomy of the esophagus, and the length and amount of tissue affected with Barrett's. | |
| RFA Treatment Group<br>Subjects will undergo radio frequency ablation treatment for dysplastic Barrett's Esophagus as per standard of care. The treatment type (balloon cryotherapy vs RFA) is determined by the endoscopy physician at the time of the procedure and is based on several clinical factors including co-existing medical conditions, the anatomy of the esophagus, and the length and amount of tissue affected with Barrett's. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pain quality immediately pre-procedure (Baseline) for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS) | Differences in PQAS scores between groups will be determined by using the t test or Wilcoxon test for continuous variables and the Fisher exact test for categorical variables. The Pain Quality Assessment Scale (PQAS) assesses distinct pain qualities associated with all types and categories of pain problems. The PQAS is a 20-item measure used to assess pain qualities associated with non-neuropathic pain. The PQAS asks respondents to rate the severity of each of 20 pain (quality and spatial) descriptor domains by using 0 to 10 numeric rating scales, in which 0 = no pain or not [ descriptor/item] and 10 = the most [descriptor] pain sensation imaginable. | immediately before procedure | 
| Difference in pain quality immediately post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS) | Differences in PQAS scores between groups will be determined by using the t test or Wilcoxon test for continuous variables and the Fisher exact test for categorical variables. The Pain Quality Assessment Scale (PQAS) assesses distinct pain qualities associated with all types and categories of pain problems. The PQAS is a 20-item measure used to assess pain qualities associated with non-neuropathic pain. The PQAS asks respondents to rate the severity of each of 20 pain (quality and spatial) descriptor domains by using 0 to 10 numeric rating scales, in which 0 = no pain or not [ descriptor/item] and 10 = the most [descriptor] pain sensation imaginable. | immediately post procedure | 
| Difference in pain quality 2 days post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS) | Differences in PQAS scores between groups will be determined by using the t test or Wilcoxon test for continuous variables and the Fisher exact test for categorical variables. The Pain Quality Assessment Scale (PQAS) assesses distinct pain qualities associated with all types and categories of pain problems. The PQAS is a 20-item measure used to assess pain qualities associated with non-neuropathic pain. The PQAS asks respondents to rate the severity of each of 20 pain (quality and spatial) descriptor domains by using 0 to 10 numeric rating scales, in which 0 = no pain or not [ descriptor/item] and 10 = the most [descriptor] pain sensation imaginable. | 2 days post procedure | 
| Difference in pain quality 1 week post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS) | Differences in PQAS scores between groups will be determined by using the t test or Wilcoxon test for continuous variables and the Fisher exact test for categorical variables. The Pain Quality Assessment Scale (PQAS) assesses distinct pain qualities associated with all types and categories of pain problems. The PQAS is a 20-item measure used to assess pain qualities associated with non-neuropathic pain. The PQAS asks respondents to rate the severity of each of 20 pain (quality and spatial) descriptor domains by using 0 to 10 numeric rating scales, in which 0 = no pain or not [ descriptor/item] and 10 = the most [descriptor] pain sensation imaginable. | 1 week post procedure | 
| Difference in pain quality 4 weeks post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS) | Differences in PQAS scores between groups will be determined by using the t test or Wilcoxon test for continuous variables and the Fisher exact test for categorical variables. The Pain Quality Assessment Scale (PQAS) assesses distinct pain qualities associated with all types and categories of pain problems. The PQAS is a 20-item measure used to assess pain qualities associated with non-neuropathic pain. The PQAS asks respondents to rate the severity of each of 20 pain (quality and spatial) descriptor domains by using 0 to 10 numeric rating scales, in which 0 = no pain or not [ descriptor/item] and 10 = the most [descriptor] pain sensation imaginable. | 4 weeks post procedure |