Clinical trial NCT03387982: Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study
Official title: Post Procedural Pain Assessment in Patients Undergoing Balloon Cryotherapy Compared to Radiofrequency Ablation (RFA) for Dysplastic Barrett's: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett Esophagus
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Long Island Jewish Medical Center
name: Pentax Medical
name: Virginia Commonwealth University
First posted: 2018-01-02
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for treatment of Barrett's Esophagus.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in pain quality immediately pre-procedure (Baseline) for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS)
timeFrame: immediately before procedure
measure: Difference in pain quality immediately post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS)
timeFrame: immediately post procedure
measure: Difference in pain quality 2 days post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS)
timeFrame: 2 days post procedure
measure: Difference in pain quality 1 week post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS)
timeFrame: 1 week post procedure
measure: Difference in pain quality 4 weeks post-procedure for subjects receiving Balloon Cryotherapy or Radiofrequency Ablation via the Pain Quality Assessment Scale (PQAS)
timeFrame: 4 weeks post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Queens
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Geisinger Clinic
name: Harshit Khara, MD
role: PRINCIPAL_INVESTIGATOR
References: