Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study

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

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• United States
  • New York
    • Queens, New York, United States, 11040
      • Long Island Jewish Medical Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for treatment of Barrett's Esophagus.

Description

Inclusion Criteria:

1. Patients with dysplastic Barrett's esophagus (LGD and HGD) naïve to ablation therapy presenting for ablation
2. Age ≥ 18
3. Ability to sign informed consent

Exclusion Criteria:

1. Prior ablation treatment for Barrett's esophagus
2. Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Balloon Cryotherapy Treatment Group; 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; 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?

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

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: Medical University of South Carolina; Virginia Commonwealth University; Long Island Jewish Medical Center; Pentax Medical
• Investigators: Principal Investigator: Harshit Khara, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): February 16, 2021
• Study Completion (Actual): February 16, 2021

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 2017-0363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No