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OpenTrials
Completed

NCT Number: NCT03387982

Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Long Island Jewish Medical Center, Queens, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Difference in pain quality immediately pre-procedure (Baseline) for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS)

    Time frame: immediately before procedure

    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. Difference in pain quality immediately post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS)

    Time frame: immediately post procedure

    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."

  3. Difference in pain quality 2 days post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS)

    Time frame: 2 days post procedure

    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. Difference in pain quality 1 week post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS)

    Time frame: 1 week post procedure

    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."

  5. Difference in pain quality 4 weeks post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS)

    Time frame: 4 weeks post procedure

    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."

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • Long Island Jewish Medical Center
  • Medical University of South Carolina
  • Pentax Medical
  • Virginia Commonwealth University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 2, 2018
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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