Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study

NCT03387982 | Completed

• 1 other identifier: 2017-0363
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for treatment of Barrett's Esophagus.

You may qualify if:

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

You may not qualify if:

• Prior ablation treatment for Barrett's esophagus
• Pregnancy

Sponsors & Collaborators

• Geisinger Clinic: lead
• Medical University of South Carolina: collaborator
• Long Island Jewish Medical Center: collaborator
• Pentax Medical: collaborator
• Virginia Commonwealth University: collaborator

Study Sites (4)

Long Island Jewish Medical Center

Queens, New York, 11040, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Harshit Khara, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Medicine; Director of Endoscopic and Translational Research

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: January 2, 2018
• Study Start: November 1, 2017
• Primary Completion: February 16, 2021
• Study Completion: February 16, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)